[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"medical-device\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:medical-device":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,70,95,125,150,182,209],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100542689","effect-of-virtual-reality-on-patients-comfort-during-cardiac-electronic-device-implantation-100542689",false,"NCT06346132","Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.","Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.","Inclusion Criteria:\n\n* Patients over 18 year old,\n* Patients who signed the consent form and accepted to participate to the trial,\n* New cardiac electronic device implantation or cardiac electronic device battery change,\n* Surgical procedure planned in ambulatory care.\n\nExclusion Criteria:\n\n* Communication limitations,\n* Surgical procedure planned in sedation or narcosis,\n* Severe sensorial deficits (visual, auditory),\n* Claustrophobia,\n* Known motion sickness,\n* Patient isolated or with contact precautions,\n* Known or anticipated psychiatric diseases,\n* Patient known for epilepsia,\n* Opened scar and or ongoing infection at the level of the face and\u002For eyes,\n* Patient evaluated non suitable for the study by the surgeon, cardiologist or anesthetist.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia.",[26,27,28,29],"Virtual Reality","Medical Device","Local Anesthesia","Pain","RECRUITING","2026-03-18",{"date":33,"type":34},"2026-03-20","ACTUAL",{"date":36,"type":34},"2024-03-29",{"date":38,"type":20},"2026-12-31",{"name":40,"class":41},"Schlotterbeck Hervé","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100499287","multicentre-randomised-study-comparing-a-taurolidine-lock-and-a-standard-saline-lock-in-paediatric-oncology-100499287","NCT05781295","Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology","Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.","PEDIALOCK","Inclusion Criteria:\n\n1. Patient less than or equal to 21 years of age at inclusion.\n2. Patient for whom a central catheter is planned to be inserted\\*, excluding a non-tunneled femoral or cervical external catheter or a peripherally inserted central catheter (as PICC line). \\*1st catheter placement or placement following a relapse (this placement must take place at least one month after previous catheter removal).\n3. Patient treated for a cancer.\n4. Patient with regular follow-up in the inclusion center.\n5. Informed consent signed by the patient if adult or by legal representatives if minor.\n6. Patient benefiting from a social security coverage.\n7. Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks.\n\nExclusion Criteria:\n\n1. Patient with retinoblastoma.\n2. Allografted patient.\n3. Patient with a life expectancy of less than 6 months.\n4. Patient refusing to participate in the protocol.\n5. Patient already receiving a central venous catheter-related infection prevention lock (ILCVC).\n6. Patient with known allergy to citrate or (cyclo)-Taurolidine.\n7. Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine.\n8. Patient with an external femoral catheter.\n9. Patient with a PICCLINE-type peripheral venous inserted central catheter.\n10. Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.\n11. Patient under guardianship and curatorship.","21 Years",{"count":53,"type":20},148,[23],"Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology.\n\nMulticentric, controlled, randomized and double-blind label study.",[57,27,58,59],"Children","Primary Prevention","Oncology","2026-02-18",{"date":62,"type":34},"2026-02-20",{"date":64,"type":34},"2024-01-19",{"date":66,"type":20},"2028-07-23",{"name":68,"class":41},"Institut Curie",5,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":42},"100543605","opioid-dispenser-for-microdiscectomylaminectomy-100543605","NCT06358040","Opioid Dispenser for Microdiscectomy\u002FLaminectomy","Use of a Novel Device to Dispense Postoperative Opioids in Patients Undergoing Microdiscectomy\u002FLaminectomy: A Pilot Study","Inclusion Criteria:\n\n* opioid-naive patients or intermittent opioid users within 3 months of scheduled surgery\n* At least 18 years old\n* presenting for primary elective one-level lumbar laminectomy and\u002For discectomy via posterior approach with participating surgeon\n* planned discharge on day of surgery\u002F23 hour admission\n* planned discharge to home\n\nExclusion Criteria:\n\n* patients with opioid-tolerance\n* patients without a smart-phone or without the ability to perform Telehealth visits\n* patients unable to utilize the medication dispensing device\n* patients presenting for other surgeries\u002Fsurgeries with combined anterior\u002Flateral approaches\n* patient refusal\n* allergy or intolerance to opioids\n* planned admission after surgery\n* planned discharge disposition to nursing facility or skilled rehabilitation\n* planned use of or preference for opioid other than oxycodone\n* patients who are pregnant",{"count":78,"type":20},30,[23],"The opioid crisis continues to plague the United States. While great strides have been made nationwide to decrease overprescribing, improvements are still needed to appropriately educate patients on the safe and responsible use, storage and disposal of opioids. Pain after surgery is often treated with opioid medications. Opioid medications can have side effects. Some side effects are relatively minor (constipation, nausea, vomiting), while others are more severe (sedation, abnormal breathing, etc.) and can lead to serious illness or death. Opioid pain medications when used the wrong way may also be addictive. Due to theses side effects, sometimes patients feel uncomfortable about taking these medications, and doctors prescribe them very cautiously. However, when used properly and safely, opioid pain medications are excellent pain relievers.\n\nAddinex, a technology company, has developed a device to help patients take opioids more safely. In this study the investigators aim to enroll a total of 30 patients who undergo spine surgery. Half will be randomly assigned to receive a standard pill bottle with opioids at discharge and will download a mobile app so that they can record their daily pain scores and the number of opioids they take for two weeks after surgery. The other half will receive the new opioid dispenser filled with opioids and a mobile app that generates a passcode that opens that device only at designated times. For this group of patients, every time the patient wants to take an opioid, they need to go to the app, enter their pain score before the app generates a passcode. The investigators will be tracking all study patients' opioid use and pain scores for the two weeks after surgery, will count how many pills they have left over 14 days after their surgery during a live telehealth session, and ask patients how they liked using the device. Results from this study will help understand if the Addinex device could potentially be useful to patients in the future after surgeries as opposed to typical pill bottles.",[82,83,27,84,85],"Opioid Use","Pain, Postoperative","Laminectomy","Diskectomy","2025-12-02",{"date":88,"type":34},"2025-12-08",{"date":90,"type":20},"2026-10",{"date":92,"type":20},"2026-12",{"name":94,"class":41},"Hospital for Special Surgery, New York",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":121,"locationsCount":124},"100573400","clinical-validation-of-bonemri-in-the-spine-100573400","NCT06745791","Clinical Validation of BoneMRI in the Spine","CleverBones","Inclusion Criteria:\n\n* ≥ 12 years old\n* Indication for diagnostic MRI of the spine\n* Indication for diagnostic CT of the spine\n* Eligible for MRI\n* Eligible for CT\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* History of (psychiatric) disorder which causes the patient to be incompetent to make a thought-out decision\n* claustrophobia\n* \\>3 months between CT and MRI scan","12 Years",{"count":104,"type":20},450,"OBSERVATIONAL","BoneMRI is a quantitative 3D MRI technique that has been developed recently by MRIGuidance BV©, which is based on a multiple gradient-echo sequence and a machine learning processing pipeline. The BoneMRI technology is capable of generating CT-like, quantitative radiodensity bone MRI images to visualize cortical and trabecular bone, allowing to assess bone structure and morphology, in addition to regular clinical MRI images. The use of BoneMRI has been investigated and clinically validated in multiple musculoskeletal studies involving the cervical spine, hip and sacro-iliac joint. In order to clinically use BoneMRI in the entire spine, the BoneMRI technology needs to be validated in that area as well, focussing on geometrical and voxelwise accuracy of the radiodensity contrast to assure accurate visualization of the osseous structures. As robustness against expected data variability between hospitals is crucial for successful machine learning algorithms, multiple MR field strengths and scanner types from different manufacturers will be included in this study. If successful, BoneMRI will facilitate a better, easier and cheaper workflow by enabling diagnosis, treatment planning and surgical navigation using a single radiological examination, without the potential hazards of ionizing radiation.",[108,109,27],"Bone Diseases","Image",[111,112,113,114],"medical device","software","synthetic CT","MRI sequence","2025-09-23",{"date":117,"type":34},"2025-09-24",{"date":119,"type":34},"2021-08-20",{"date":38,"type":20},{"name":122,"class":123},"MRIguidance B.V.","INDUSTRY",10,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":42},"100590512","the-covid-dome-trial-100590512","NCT06968377","The COVID Dome Trial","Preliminary Clinical Evaluation of a Novel Airborne Pathogen Containment Device Design: Randomized Open-label Equivalence Trial of Patient Safety and Acceptability During Endotracheal Intubation.","Inclusion Criteria:\n\n* ASA class 1 and 2\n* Elective surgery\n* Adults \\>18 years of age\n* Ability to give informed consent\n* Surgery in supine or lithotomy position\n* Surgical site: abdominal, pelvic, lower limb or distal upper limb\n* Endotracheal intubation is indicated as per attending anesthesiologist\n\nExclusion Criteria:\n\n* BMI \\>40\n* pregnancy\n* \"full stomach\" or increased intraabdominal pressure (as per attending anesthesiologist)\n* predictors of difficult airway management as per attending anesthesiologist\n* airway management plan (as per attending anesthesiologist) that is incompatible with study protocol\n* initial ventilatory settings that are incompatible with planned care as per study protocol\n* anxiety disorder (including claustrophobia)\n* significant cardiovascular or respiratory disease (including pleural effusion, pulmonary edema, etc.)\n* anticipated significant level of post-operative sedation preventing survey participation",true,{"count":134,"type":20},80,[23],"The aim of this study is to test a bubble-like dome (made of clear plastic) being placed over patients' heads during surgery as a tool to prevent the spread of germs through the air in hospitals.\n\nThe researchers are interested in the following outcomes:\n\n* How the device affects the patients' experience of surgery.\n* The impact of the device on how long it takes to place a breathing tube, blood pressure, heart rate and oxygen levels of the patient.\n\nResearchers will compare the outcomes across patients using the device and patients not using the device. This will be done by randomly (by chance) assigning participants undergoing surgery to group 1 (using the bubble-like dome device) or group 2 (not using the device).\n\nParticipants will:\n\n* Tell the researchers or your anesthesia doctor about any problems that you experience that you think might be related to participating in the study.\n* Fill out a 10-minute survey regarding your experience with the dome after surgery.\n* If you did not try the dome before going to sleep, you will be able to watch a video of the dome in use and answer questions based on the video\n* Be video recorded with your time with the dome.",[27,138,139],"Medical Device Performance","Aerosol Generating Procedure","NOT_YET_RECRUITING","2025-05-06",{"date":143,"type":34},"2025-05-13",{"date":145,"type":20},"2025-05-15",{"date":147,"type":20},"2026-05-15",{"name":149,"class":41},"IWK Health Centre",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":168,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100541796","ventilation-of-the-extremely-premature-infants-optimized-by-dead-space-washout-100541796","NCT06334523","Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout","Open Randomised Study of Conventional Ventilation Optimised by Dead Space Washout in Extremely Premature Infants","Volem","Inclusion Criteria:\n\n* Gestational Age at birth between 23 weeks gestation + 0 days and 26 weeks gestation + 6days\n* Age between 0 and 7 days of life\n* Need for intubation and mechanical ventilation before day 8 of life\n* Availability of the Research-associated medical devices\n* Beneficiary of a social security system (in France: CMU or securité sociale)\n* Parental consent for their infant to participate in this trial\n\nExclusion Criteria:\n\n* Known Severe Congenital Malformation (potential life-threatening malformation)\n* Known Preexisting Severe Intraventricular Haemorrhage (grade 3 or 4) and\u002For other brain abnormality that can alter life prognosis\n* Known Genetic Disorder (potential life-threatening malformation)\n* Preexistent mechanical ventilation for a duration of more than 12 hours\n* Participation in another interventional research trial before inclusion","7 Days",{"count":160,"type":20},144,[23],"The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses. This objective is of particular interest in the smallest preterm infants, where the volume of anatomical dead space due to prostheses is little different from the tidal volume. The principle of this option is to continuously blow an additional flow of 0.2 L\u002Fminute at the tip of the endotracheal tube to purge expired CO2 trapped in the prostheses, to have a CO2-free volume of gas available for subsequent insufflation.\n\nThe goal of this clinical trial is to learn if Continuous Tracheal Gas Insufflation (CTGI) works to reduce ventilatory dependence in preterm infants after mechanical ventilation. It will also learn about the safety of CTGI. The main questions it aims to answer are:\n\n* Does Continuous Tracheal Gas Insufflation (CTGI) reduce the number of days of non-invasive ventilation in extremely preterm infants who needed mechanical ventilation?\n* Does Continuous Tracheal Gas Insufflation (CTGI) reduce the age at the weaning of any ventilatory support and\u002For oxygen supplementation.\n\nResearchers will compare the clinical outcome of patients mechanically ventilated with the CTGI-device to the outcome of patients ventilated without the CTGI device, to see if the CTGI ventilation works to reduce ventilation dependence.\n\nParticipants will:\n\n• Be mechanically ventilated using CTGI (if randomly assigned in the CTGI-group), for the entire endotracheal ventilation period during their stay in the neonatal intensive care unit.",[164,165,27,166,167],"Extremely Low Birthweight Infant","Continuous Tracheal Gas Insufflation","Lung Protection","Ventilator-Induced Lung Injury",[169,170,167,171],"lung protection","extremely low birthweight infant","mechanical ventilation","2025-02-03",{"date":174,"type":34},"2025-02-05",{"date":176,"type":20},"2025-02-13",{"date":178,"type":20},"2029-04-03",{"name":180,"class":41},"Centre Hospitalier Intercommunal Creteil",4,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":42},"100576150","evaluation-of-the-performance-and-safety-of-a-type-i-collagen-based-medical-device-md-small-joints-collagen-medical-device-i-the-treatment-of-rhizoartrosis-100576150","NCT06781554","Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS","Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS. \"SMAGENART PILOT STUDY\"","SMAGENART","Inclusion Criteria:\n\n* Male and female subjects aged between 18 and 75 years;\n* Subjects with clinically diagnosed symptomatic thumb carpometacarpal osteoarthritis confirmed radiographically (stages I and II according to Eaton and Littler's classification);\n* \\[N.B. in case of bilateral symptomatic thumb carpometacarpal osteoarthritis, treatment can be unilateral only, at the level of the thumb carpometacarpal joint that is more affected at the time of enrollment\\].\n* Subjects with a VAS score ≥ 5; \\[The request for pain intensity (VAS) from the patient should refer to moments of hand use, nota t rest!\\]\n* Subjects with joint pain for at least 1 month;\n* Subjects not using thumb carpometacarpal orthotic devices;\n* Subjects agreeing not to take analgesics within 24 hours before the scheduled visits;\n* Subjects capable of understanding and signing the Informed Consent.\n\nExclusion Criteria\n\n* Subjects with rheumatological conditions involving the hands;\n* Subjects who have undergone hand surgery for the affected pathology;\n* Subjects who have received HA injections in the thumb carpometacarpal joint in the last 3 months;\n* Subjects who have taken NSAIDs in the last 7 days and\u002For corticosteroids in the last 30 days;\n* Subjects undergoing physical therapy such as X-ray therapy, Tecar therapy, shock wave therapy, laser therapy, ultrasound therapy in the last 3 months;\n* Subjects with neoplastic pathology;\n* Subjects with systemic infections;\n* Subjects with uncontrolled diabetes;\n* Subjects with neurological conditions that may affect active participation in the study;\n* Subjects with coagulopathies or taking anticoagulants (vitamin K antagonists, heparin);\n* Subjects undergoing immunosuppressive treatment;\n* Subjects using drugs or abusing alcohol;\n* Subjects allergic to porcine collagen;\n* Female subjects who are pregnant or breastfeeding;\n* Subjects participating in other clinical studies during the same period;\n* Subjects unable to cooperate or for whom poor compliance is expected;\n* Any condition that, in the investigator's judgment, recommends the subject's exclusion.","75 Years",{"count":192,"type":20},42,[23],"Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix. Its structure, characterized by the presence of glycine every third residue, a high content of proline and hydroxyproline, is stabilized by interchain hydrogen bonds and electrostatic interactions, giving the molecules high mechanical resistance, incompressibility, and simultaneously, extensibility, plasticity, and flexibility, making tissues abundant in collagen particularly resistant to stress and load. In humans, collagen is present especially in the skin, subcutaneous tissue, cartilage, bone, joint capsule, tendons, muscles, and ligaments.\n\nGrowing evidence supports the infiltrative use of type I collagen in the treatment of musculoskeletal pathologies. In particular, the intra-articular and peri-articular use of collagen has been proposed in the treatment of osteoarthritis in various body districts with the intention of limiting joint hypermobility, stabilizing the structure of joint and peri-articular components, reducing pain, and consequently improving function. Several clinical studies have demonstrated that its intra-articular infiltrative use could result in pain reduction and improvement of functionality in various cases of gonarthrosis and coxarthrosis. Regarding the conservative management of symptomatic thumb base osteoarthritis, some studies, albeit on limited case series, have highlighted how the use of type I collagen at the joint and peri-articular level can lead to better control of painful symptoms, improvement in functionality, and reduction of joint instability.\n\nRecently, Randelli F. et al. studied the in vitro effects on tenocytes induced by type I swine collagen (MD-Tissue Collagen Medical Device). In vitro results seem to demonstrate that this medical device can induce proliferation and migration of tenocytes and synthesis, maturation, and secretion of type I collagen, favoring tendon repair.\n\nRandelli F. et al. also demonstrated the mainly mechanical activity of MD-Tissue Collagen Medical Device, which is able to induce modifications of morpho-functional properties of tenocytes.\n\nIn this Clinical Investigation, we aim to investigate the performance and safety of an injectable medical device based on type I collagen of swine origin called MD-Small Joints Collagen Medical Device, in the treatment of symptomatic thumb base osteoarthritis.\n\nThe purpose of this research project is to understand through a multicenter Clinical Investigation, the performance and safety of an intra-articular and peri-articular treatment with a medical device (MD-Small Joints Collagen Medical Device) based on type I collagen in terms of pain reduction and joint function recovery in subjects with symptomatic thumb base osteoarthritis. The primary endpoint will consist of evaluating, through the Visual Analogue Scale (VAS), the performance of MD-Small Joints Collagen Medical Device in reducing pain associated with trapeziometacarpal osteoarthritis, at time T6 weeks (T6w) compared to T0 (day0). A reduction of at least 30% in the VAS score is considered clinically significant.\n\nSecondary endpoints will consist of evaluating the performance of MD-Small Joints Collagen Medical Device through:\n\n* VAS score assessment at T3 week and T16week \u002FFU compared to T0;\n* Disability of the Arm Shoulder and Hand score assessment at T6 week and T16 week \u002FFU compared to T0 (day0);\n* Functional Index for Hand Osteoarthritis assessment at T6 week and T16 week \u002FFU compared to T0;\n* Pinch Strength Test assessment at T6 week and T16 week\u002FFU compared to T0;\n* Evaluation of analgesic drug consumption through clinical diary in various study phases;\n* Assessment of Adverse Event incidence.",[196,197,198,199],"Trapeziometacarpal Osteoarthritis","Rhizarthrosis","MEDICAL DEVICE","Infiltrate","2025-01-13",{"date":202,"type":34},"2025-01-17",{"date":204,"type":34},"2024-11-18",{"date":206,"type":20},"2026-03-30",{"name":208,"class":123},"Guna S.p.a",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100571975","safe-infusion-study-100571975","NCT06727240","Safe-Infusion Study","A Non-Inferiority Randomized Clinical Trial Investigating Efficacy and Safety of an Innovative Medical Device in the Reduction of Mechanical Complications of Peripheral Intravenous Catheters","Inclusion Criteria:\n\n* The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥2h and intermitted as an infusion lasting 15min to \\\u003C2h.\n* ≥18 years of age\n* Speak and understand local language\n* VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion\n* Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent\n\nExclusion Criteria:\n\n* The VAD is expected to be used for sampling only\n* Pregnancy\n* Unable to obtain informed consent or without an available LAR to provide surrogate informed consent\n* Patients under palliative care\n* Bolus IV infusion, defined as an infusion time of \\\u003C15 min",{"count":217,"type":20},548,[23],"Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. This study aims to assess a new device's effectiveness in reducing mechanical complications associated with PIVCs through a non-inferiority randomized trial at two sites. A total of 548 patients will be recruited, with primary outcomes focused on complication rates and secondary outcomes examining adverse events, healthcare feedback, and economic impacts.",[221,27],"Intravenous Access","2024-12-11",{"date":224,"type":34},"2024-12-16",{"date":226,"type":34},"2024-03-25",{"date":228,"type":20},"2025-03",{"name":230,"class":123},"Interlinked AB",2]