[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"digestive-system-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:digestive-system-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,76,109,137,162,194,219,247,273],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100598834","phase-3-efficacy-and-safety-of-intravenous-lidocaine-versus-placebo-in-patients-receiving-morphine-rachi-analgesia-100598834",false,"NCT07076641","Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia","Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Analgesic Morphine Rachi Anesthesia for Major Digestive or Abdominal Surgery by Laparotomy.","LIDORACHI","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynecological, esophageal, gastric, duodenal, small intestine...);\n* Scheduled surgery;\n* Laparotomy;\n* Patient in agreement with morphine rachi anesthesia;\n* Social security affiliation;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Emergency surgery;\n* Contraindication to non-steroidal anti-inflammatory drugs: history of gastro duodenal ulcer, renal failure from stage 3 A or higher;\n* History of bradycardia and\u002For known conduction disorder (atrioventricular block) \u002F Pacemaker ;\n* Unstable coronary ;\n* Myocardial infarction \\\u003C6 months;\n* Severe cardiocirculatory insufficiency;\n* Severe hepatic insufficiency;\n* Allergy to morphine ;\n* Allergy to lidocaine;\n* Rhythm disorders at risk of sudden death (e.g. Brugada syndrome);\n* Flecaine as usual treatment;\n* Chronic pain with level II or III analgesics;\n* Gabapentinoids: pregabalin (Lyrica), gabapentin;\n* Drug addiction and substitute drugs;\n* Epileptic disorders ;\n* Myasthenia gravis;\n* Creatinine clearance below 10 mL\u002Fmin;\n* Hypokalemia, hypoxia or acid-base disorders;\n* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;\n* Inability to understand study information (due to linguistic, psychological, cognitive or literacy problems);\n* Women who are or may become pregnant\\* (of childbearing age, without effective contraception) or who are breast-feeding;\n* Patient deprived of liberty, under guardianship or unable to give consent.","ALL","18 Years",{"count":20,"type":21},76,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the superiority of IV lidocaine combined with morphine spinal anesthesia versus placebo combined with morphine spinal anesthesia, in reducing postoperative morphine consumption at 48 hours, in patients undergoing major digestive or abdominal surgery by laparotomy.",[27,28],"Digestive System Disease","Surgery","NOT_YET_RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":21},"2026-07",{"date":37,"type":21},"2027-07-30",{"name":39,"class":40},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":73,"locationsCount":41},"100536954","phase-4-evaluation-of-efficacy-of-skl-pro-powder-on-symptoms-of-irritable-bowel-syndrome-100536954","NCT06271538","Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome","A Randomized Double-Blind Placebo-controlled Clinical Trial on the Efficacy of Skål Pro (Lactobacillus Plantarum 299 and Galacto-oligosaccharides) in Improving Severity of Symptoms, Stool Forms, Quality of Life and Psychological Dysfunction in Patients With Irritable Bowel Syndrome (IBS)","Inclusion Criteria:\n\n* IBS diagnosed using the Rome IV criteria\n* Age above 18 years old and any gender\n* Any subtypes of IBS (diarrhea, constipation or mixed)\n\nExclusion Criteria:\n\n* Presence of red flag symptoms (weight loss, anemia, night symptoms, abdominal mass, strong family history of cancer)\n* Was prescribed antibiotic (s) within the past one month\n* Medical conditions that contraindicate probiotic use including severe sepsis and pregnancy\n* Presence of bowel malignancy\n* Diagnosis of bowel infection within the past one month\n* Previous abdominal surgeries\n* Patients with overt psychiatric illnesses including schizophrenia and manic disorders\n* A history of allergy to probiotic\n* Was prescribed probiotic (s) within the past one month\n* Was previously prescribed probiotic Skal Pro™ (LP299V™)",{"count":50,"type":21},60,[52],"PHASE4","The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention.",[55,56,57,58,27,59,60,61],"Irritable Bowel Syndrome","Gastrointestinal Diseases","Colonic Diseases, Functional","Intestinal Disease","Pathologic Processes","Colonic Disease","Disease",[63,64,65],"probiotic","Lactobacillus plantarum 299v","randomized controlled study","RECRUITING","2026-05-11",{"date":69,"type":33},"2026-05-12",{"date":71,"type":33},"2024-10-17",{"date":30,"type":21},{"name":74,"class":75},"EP Plus Group Sdn Bhd","INDUSTRY",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100486305","colonoscopy-vs-stool-testing-for-older-adults-with-colon-polyps-100486305","NCT05612347","Colonoscopy vs Stool Testing for Older Adults With Colon Polyps","Colonoscopy Versus Stool-based Testing for Older Adults With a History of Colon Polyps","COOP","Inclusion Criteria:\n\n* English or Spanish speaking\n* Personal history of colorectal polyps\n* Most recent colonoscopy with ≤2 non-advanced polyps\n* Currently due or coming due within 12 months for colonoscopy\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Personal history of colorectal cancer\n* Personal history of genetic syndrome with high risk for colorectal cancer (e.g. Lynch Syndrome, Familial Adenomatous Polyposis Syndrome (FAP), or Serrated Polyposis Syndrome)\n* Personal history of inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease)\n* Most recent colonoscopy with advanced polyp(s) or ≥3 non-advanced polyps\n* Patients unlikely to benefit from polyp surveillance (e.g., history of heart disease or coronary artery disease with treatment in the last 6 months, heart failure affecting function, lung disease requiring use of home oxygen, stroke within the last 4 months, dementia affecting activities of daily living (ADL) or instrumental activities of daily living (IADL), severe liver disease requiring the use of certain medications to control fluid, confusion, or bleeding, severe kidney disease requiring dialysis, or a new cancer diagnosis within the last year)\n* Patients unable to provide written informed consent","65 Years","82 Years",{"count":87,"type":21},8946,[89],"NA","This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.",[92,93,94,95,27],"Colorectal Polyp","Colorectal Neoplasms","Colorectal Adenoma","Colorectal Cancer",[97,98],"Colonoscopy","Fecal immunochemical test (FIT)","2026-05-01",{"date":101,"type":33},"2026-05-07",{"date":103,"type":33},"2023-06-14",{"date":105,"type":21},"2035-12-31",{"name":107,"class":40},"Dartmouth-Hitchcock Medical Center",22,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":117,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":41},"100444339","multidisciplinary-evaluation-of-elderly-patients-with-digestive-cancer-epodig-g-100444339","NCT05066139","Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)","Monocentric Randomized Study Evaluating the Impact of an Early Multidisciplinary Program in Elderly Subjects Starting a Chemotherapy for Digestive Cancer: Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)","EPODIG-G","Inclusion Criteria:\n\n* Patients must be ≥ 75 years old\n* Performance status 0, 1 or 2\n* Diagnostic of digestive cancer, all stages (adjuvant or metastatic), with an indication for chemotherapy treatment or targeted therapy for a treatment period of 24 weeks or more\n* Patients previously treated with one or several lines of chemotherapy for this digestive cancer are eligible\n* Estimated life expectancy ≥ 3 months\n* Patients able to speak, read and understand French\n* Signed informed consent from the patient\n* Patients must have a social security coverage\n\nExclusion Criteria:\n\n* History of differentiated neuroendocrine tumors grade 1 or 2 (pancreas, small intestine)\n* Cancer currently being treated (except for hormone therapy) other than current digestive cancer\n* History of major surgery and\u002For curative radiation therapy during the last 4 weeks before inclusion\n* Patients unable to submit to medical follow-up for geographical, social or psychological reasons\n* Patients placed under guardianship","75 Years",{"count":119,"type":21},144,[89],"This is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in Strasbourg Europe Cancerology Institute (ICANS), starting chemotherapy or targeted therapy for the treatment of digestive cancer.",[27,123],"Neoplasms",[125,126,127],"Digestive cancer","supportive care","gastrointestinal cancer","2025-12-30",{"date":130,"type":33},"2026-01-05",{"date":132,"type":33},"2021-09-17",{"date":134,"type":21},"2030-10-17",{"name":136,"class":40},"Centre Paul Strauss",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":144,"sex":17,"minAge":145,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":41},"100601739","phase-3-a-study-to-evaluate-safety-and-efficacy-of-pbkm2502-100601739","NCT07114406","A Study to Evaluate Safety and Efficacy of PBK_M2502","A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2502","Inclusion Criteria:\n\n* Patients who is informed and give a consent in voluntary\n* Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy\n* BMI 19≤and\\\u003C30\n\nExclusion Criteria:\n\n* Patients who participate in other interventional study or had participated within 30 days before screening\n* Pregnant or breast-feeding women who do not want to stop breast-feeding\n* Uncontrolled hypertension\n* Uncontrolled diabetes\n* Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance\n* HIV infection and\u002For chronic hepatitis B or C\n* Patients who has a difficulty to participate because of severe nausea or vomiting\n* History of colon surgery and abdominal surgery within 6 month; need an emergency surgery",true,"19 Years",{"count":147,"type":21},110,[24],"This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.",[58,151,152,27],"Colonic Diseases","Gastrointestinal Disease","2025-08-03",{"date":155,"type":33},"2025-08-11",{"date":157,"type":21},"2025-08",{"date":159,"type":21},"2026-11",{"name":161,"class":75},"Pharmbio Korea Co., Ltd.",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":144,"sex":17,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":180,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100455362","immune-responses-to-gluten-100455362","NCT05209568","Immune Responses to Gluten","Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten","Inclusion Criteria:\n\n1. On a gluten-free diet for ≥ 4 weeks\n2. Willing to consume gluten for research\n3. For the celiac disease arm, diagnosis confirmed by serology and\u002For histology\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Wheat allergy\n3. Type 1 diabetes\n4. BMI z-score \\\u003C -2\n5. History of more than minimal symptoms following gluten exposure on a gluten-free diet\n6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results","2 Years","101 Years",{"count":172,"type":21},400,[89],"This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.",[176,177,27,58,56,178,179],"Celiac Disease","Malabsorption Syndromes","Gluten Sensitivity","Celiac Disease in Children",[181,182,183],"gluten","cytokine","T cell immune response","2025-04-18",{"date":186,"type":33},"2025-04-23",{"date":188,"type":33},"2023-01-15",{"date":190,"type":21},"2029-09-30",{"name":192,"class":40},"Boston Children's Hospital",2,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":144,"sex":17,"minAge":18,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":204,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":41},"100399037","early-diagnosis-of-upper-digestive-tract-disease-100399037","NCT04475952","Early Diagnosis of Upper Digestive Tract Disease","E-DIGEST","Inclusion Criteria:\n\n* Any patient who:\n\n  * is ≥ 18 years old and below 90 years of age, AND:\n  * is undergoing endoscopy as part of their routine clinical care, OR:\n  * is undergoing surgical resection of orodigestive tract disease as part of their routine clinical care, OR:\n  * is undergoing treatment of orodigestive tract disease as part of their routine clinical care\n\nExclusion Criteria:\n\n* Any patient who:\n\n  * Lacks capacity or is unable to provide informed consent.\n  * Any patient below 18 years of age or over 90 years of age.","90 Years",{"count":203,"type":21},180,"OBSERVATIONAL","Upper digestive tract cancer (UDC) is a major disease burden worldwide encompassing all cancers involving the digestive tract (from oral cavity to duodenum). A majority of patients presenting with this disease are diagnosed late and have poor overall survival rates (\\\u003C20%). NICE referral guidelines for diagnostic endoscopy are usually associated with late disease. Exhaled breath testing is a non-invasive and acceptable technology utilising mass spectrometry (MS) which has shown promise at diagnosing cancer at an early stage.\n\nPrevious research has shown that products formed as a result of metabolism can be measured in breath and saliva (biomarkers). This has the ability to accurately identify patients with upper gastrointestinal (UGI) cancers from breath. Our initial pilot data has demonstrated that changes in the breakdown of metabolites release volatile organic compounds (VOC) which can be measured with MS. This data is supported by other patient studies. However no previous study has been performed utilising a non-invasive technique with breath and saliva. Thus the aim of this study is to identify VOCs present in patients with this disease.\n\nIn this multi-centre study the investigators want to overcome the limitations of previous work by utilising non-invasive samples (breath, saliva and urine) in patients in multiple sites. The investigators aim to conduct a study in patients with UDC and those without. The investigators hope that the results of this study will provide evidence for large scale analysis of patients with this disease, demonstrate the feasibility of this technique and move this valuable test forward into mainstream medical practice. The major advantage of this test is that it is easy to undertake and painless for the patient. This study of products in breath, saliva and urine will be useful for detecting UDC to allow treatment at an early stage, improving overall survival.",[207,208,27,209],"Squamous Cell Carcinoma","Breath Test","Diagnose Disease","2025-02-07",{"date":212,"type":33},"2025-02-10",{"date":214,"type":33},"2019-09-13",{"date":216,"type":21},"2025-09-13",{"name":218,"class":40},"Imperial College London",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":227,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":41},"100543079","impact-assessment-of-abdominal-massage-on-feeding-tolerance-of-preterms-100543079","NCT06351202","Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms","Impact Assessment of Abdominal Massage on the Feeding Tolerance of Preterms (Less Than 34 Weeks of Amenorrhea) : a Randomized, Single-blind Controlled Trial","PREMABDO","Inclusion Criteria:\n\n* Newborn, premature, less than 34 Weeks of Amennorhea\n* at least 3 days of life\n* hospitalized in neonatal intensive care units\n* with feeding intolerance demonstrated by an ECAP (Clinical Abdominal Assessement scale for preterms) score equal to or greater than 4\u002F20\n* whose holders of parental authority are able to give free and informed consent to participate in this study.\n\nExclusion Criteria:\n\n* premature newborns with a congenital pathology such as malformation, genetic or chromosomal abnormality\n* newborns whose holders of parental authority are protected by law (under guardianship, curatorship, placed under judicial safeguard) or aged under 18\n* rejection of participation by parents\n* newborns with a contraindication to abdominal massage (fever, major hemodynamic instability)","3 Days","60 Days",{"count":230,"type":21},120,[89],"Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea - WA), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, expressed by abdominal distension, regurgitation, irregular transit and abdominal discomfort. It can influence the length of hospitalization and lead to necrotising enterocolitis, a major complication.\n\nAt the Clermont-Ferrand University Hospital Center, abdominal massages have been performed by physiotherapist for several years in order to improve the state of the digestive system of preterm infants. The indication for abdominal massages are very dependent on the caregivers in charge of the newborns because the evaluation of feeding intolerance remains subjective.\n\nIn this context, the investigators carried out a first study to validate a scale that they created (ECAP scale : Clinical Assessment Scale for Abdominal state of Preterm infant) to assess in a rapid, reliable and reproductible manner the abdominal state of preterm infant - data currently being published). This scale can pose the indications for abdominal massage more objectively.\n\nThe hypothesis is that abdominal massage improves feeding tolerance (decrease ECAP score), allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants.\n\nThe aim of the study is to assess the effectiveness of abdominal massage, over a period of 14 days, on the feeding tolerance of preterm infants (under 34 weeks of amenorrhea), defined by the achievement and maintenance of an ECAP score less than 4 during 3 days.",[234,27],"Preterm Birth Complication",[236,237],"physiotherapy","abdominal massage","2024-05-21",{"date":240,"type":33},"2024-05-22",{"date":242,"type":33},"2024-05-16",{"date":244,"type":21},"2026-06",{"name":246,"class":40},"University Hospital, Clermont-Ferrand",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":4},"100547920","improvement-of-lower-digestive-endoscopy-without-anesthesia--evaluation-of-the-virtual-reality-mask-100547920","NCT06414239","Improvement of Lower Digestive Endoscopy Without Anesthesia : Evaluation of the Virtual Reality Mask","Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie : évaluation du Masque de réalité Virtuelle","REVENDO","Inclusion Criteria:\n\nPatient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia\n\nExclusion Criteria:\n\n* Hearing problems or low vision\n* Psychiatric or cognitive disorders hindering communication\n* History of epilepsy\n* Claustrophobia which can lead to a rejection of the virtual reality mask\n* History of cybercynetosis during previous use of VR\n* Chronic abdominal pain with baseline Visual analogue scale (VAS) \\> 5\n* Emergency examination\n* Patient participating in another interventional research on digestive endoscopy\n* Patient not speaking French\n* Patient under guardianship","100 Years",{"count":257,"type":21},240,[89],"90% of colonoscopies are performed with general anesthesia (GA). GA carries risks and requires a prior anesthesia consultation, a dedicated team and technical platform on the day of the examination. These constraints increase the time it takes to organize examinations. This was particularly highlighted during the recent health crisis. The success of colonoscopy without GA varies depending on the patient's experience of the examination. Any measure allowing better tolerance of the exam is therefore likely to increase its success rate and avoid rescheduling the exam under GA. A 2017 meta-analysis showed that the use of virtual reality (VR) reduced pain and anxiety during care for burn victims, in trauma and oncology. In upper digestive endoscopy, retrospective studies have shown good tolerability of the examinations and a reduction in pain compared to patients with only local anesthesia. Thus, if the VR mask improves the success rate of total colonoscopy by improving tolerance and acceptability, more examinations without GA could be considered. It could also have an economic impact.",[27],[262,263,97,264],"Lower digestive endoscopy whatever the indication","Digestive endoscopy","Virtual reality","2024-05-13",{"date":242,"type":33},{"date":268,"type":21},"2024-06",{"date":270,"type":21},"2026-12",{"name":272,"class":40},"Assistance Publique - Hôpitaux de Paris",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":201,"enrollmentInfo":281,"targetDuration":283,"studyType":204,"phases":4,"briefSummary":284,"conditions":285,"keywords":292,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100400392","osprey-is-a-post-market-global-multicentre-observational-prospective-registry-100400392","NCT04493632","OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.","OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)","OSPREY","Inclusion Criteria:\n\n1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).\n2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.\n3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.\n4. Pancreatic target tumour recommended size of \\\u003C7 cm (longest diameter) and \\\u003C110 cc volume.\n5. A clinically acceptable ECOG performance status.\n6. Patients ≥ 18 years of age at screening.\n7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.\n8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.\n\nExclusion Criteria:\n\n1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.\n2. Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).\n3. Evidence of distant metastases based on review of baseline CT scan.\n4. More than one primary lesion.\n5. In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:\n\n   * where previous EUS-FNA was considered technically too difficult to perform;\n   * imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;\n   * presence (or significant risk) of varices near to the target tumour.\n6. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).\n7. In the setting of recent, clinically significant pancreatitis, implantation is not recommended.\n8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding.\n9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components",{"count":282,"type":21},500,"24 Months","The OSPREY Patient Registry has been developed to collect and assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.\n\nThe Registry data will provide both complementary and contemporary information to the existing clinical data across various countries and will form part of the post-market clinical follow-up activities for OncoSil™. Therefore, the Registry will be implemented only in countries with regulatory (commercial) approval for the OncoSil™ device.",[286,287,288,123,289,27,290,291],"Pancreatic Neoplasm","Digestive System Neoplasm","Neoplasms by Site","Endocrine Gland Neoplasm","Pancreatic Diseases","Endocrine System Diseases",[293,294,295,296,297,298,299,300,301,302,303,304,305,306,307],"Pancreatic Cancer","Pancreas","Metastases","Pancreatic tumor","Unresectable","Locally advanced","Implantable","Radiographic","Device","Phosphorous-32","OncoSil™","Brachytherapy","Gemcitabine","Nab-paclitaxel","Abraxane","2024-04-29",{"date":310,"type":33},"2024-04-30",{"date":312,"type":33},"2022-04-12",{"date":314,"type":21},"2027-10-01",{"name":316,"class":75},"OncoSil Medical Limited",9]