[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-diseases":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,56,90,119],{"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":38,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100619934","post-market-study-of-the-signia-circular-stapler-with-tri-staple-technology-in-left-sided-colon-sigmoid-and-rectal-resections-100619934",false,"NCT07351071","Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections","A Prospective, Multicenter, Single-arm, Post Market Study to Evaluate the Safety and Performance of the Signia™ Circular Stapler With Tri-Staple™ Technology in Elective Open or Minimally Invasive Left-sided Colon, Sigmoid, and Rectal Resections (SECURE)","SECURE","Preoperative Inclusion Criteria:\n\n1. Subject is competent and willing to provide documented informed consent to participate in this clinical study\n2. Subject is intended to undergo an elective left sided colon\u002Fcolorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler\n3. Subject is ≥ 18 years of age at time of consent\n\nPreoperative Exclusion Criteria:\n\n1. Subject is unable or unwilling to comply with the study requirements or follow-up schedule\n2. Subject with ASA classification ≥ IV\n3. Subject is pregnant (as determined by standard site practices)\n4. The procedure is an emergency procedure\n5. The procedure is a revision\u002Freoperation for the same indication\n6. The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months\n7. Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study\n8. Subject will undergo multiple synchronous colon resections\n9. Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)\n10. Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure\n11. Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)\n12. Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)\n13. Any subject undergoing an ileal-anal pouch anastomosis surgery\n\nIntraoperative Exclusion Criteria\n\n1. Anastomosis not attempted with the Signia™ circular stapler\n2. Any subject for which the device is intended to be used outside the instructions for use (IFU)","ALL","18 Years",{"count":20,"type":21},137,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.",[27,28,29,30,31,32,33,34,35,36,37],"Colorectal Anastomosis","Left-sided Colon Resection","Anastomotic Leak","Anastomotic Complication","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases","Postoperative Complications","Anastomotic Leaks",[27,28,39,29,40,41,42],"Circular stapler","Rectal cancer","Low anterior resection","Powered stapler","RECRUITING","2026-06-11",{"date":46,"type":47},"2026-06-12","ACTUAL",{"date":49,"type":47},"2025-12-30",{"date":51,"type":21},"2027-02-28",{"name":53,"class":54},"Medtronic - MITG","INDUSTRY",9,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":74,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100610070","phase-3-symbiotic-gi-03-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-metastatic-colorectal-cancer-100610070","NCT07222800","Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer","AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER","Inclusion Criteria:\n\n* Histological or cytological confirmed colorectal adenocarcinoma.\n* Evidence of Stage IV metastatic disease.\n* No prior systemic therapy for metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* At least one measurable lesion according to RECIST 1.1 per Investigator assessment.\n* Adequate hepatic, liver, and renal function\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Locally confirmed BRAF V600E mutation\n* Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer\n* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":64,"type":21},800,[66],"PHASE3","The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have colorectal cancer that has spread to other parts of your body.\n* Be in good enough health to receive study treatment.\n* Should not be pregnant before starting treatment.\n\nParticipants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.\n\nThe medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.\n\n* The study is expected to last approximately 33 months for each participant.\n* Participants will have regular visits to the study site for treatment, health checks, and tests.\n* After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.\n* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.",[69,70,71,72,31,32,33,34,35,73],"Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Colorectal Neoplasms",[75,76,77,78,79],"mCRC","metastatic disease","first-line","metastatic colorectal cancer","colon cancer","2026-06-03",{"date":82,"type":47},"2026-06-04",{"date":84,"type":47},"2025-12-11",{"date":86,"type":21},"2031-08-01",{"name":88,"class":54},"Pfizer",228,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100499342","sci-pex-study---safety-and-performance-of-pexyeazy-a-device-for-treatment-of-hemorrhoids-100499342","NCT05782010","SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids","SCI-Pex, a Multi-center, Prospective, Non-controlled Investigation to Evaluate the Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids","SCI-Pex","Inclusion Criteria:\n\n* Adult\n* Hemorrhoidal disease grade II and III\n* American Society of Anesthesiologists (ASA) classification I-III.\n\nExclusion Criteria:\n\n* Previous surgical treatment for hemorrhoids by all methods except rubber band ligation or sclerosing injection therapy within the last 3 years.\n* Previous surgical treatment with rubber band ligation or injection therapy within the last 2 months.\n* More than three surgical treatments with rubber band ligation or sclerosing injection therapy within the last 3 years.\n* Under medication with immunosuppressive drugs and\u002For anticoagulant drugs (not including 75mg acetylsalicylic acid) and not able to interrupt the anticoagulant drug medication or replace it with low molecular weight heparin for 5 days.\n* Have ulcerative colitis, Crohn's disease or other intestinal inflammatory disease or presence of inflamed or thickened mucosa of the rectum.\n* Presence of anal fissure, anal stenosis, stricture, fistulas or ulcers in the rectal area.\n* The rectum has not been prepared prior to the investigation with rectal enema and is contaminated with feces that cannot easily be removed.\n* Have schizophrenia, untreated depression or other mental illness or conditions that may affect judgment, sensation of pain or inability to complete the follow-up.\n* Under medication of morphine or other strong painkillers, not including paracetamol.\n* Fecal incontinence (not including soiling due to hemorrhoidal disease), or conditions with impaired sensation in the rectal area or impaired function of the anal sphincter.\n* Previous rectal radiation.\n* Rectal cancer or previous surgery due to rectal cancer.\n* Pregnancy\n* Hypercoagulability disorders or diseases that result in increased risk of bleeding.\n* Impaired immune system or condition that increases the risk of infection.","84 Years",{"count":100,"type":21},35,[24],"The SCI-Pex study is a multicenter, prospective, non-controlled investigation on PexyEazy®, a new device for treatment of hemorrhoids based on the mucopexy method. Mucopexy is a well established method where sutures are applied above the hemorrhoids. When knots are tied, the hemorrhoids are lifted inwards to their normal position, which makes them swell down and symptoms disappears. PexyEazy® perform a mukopexy in a semiautomatic, faster and easier way on awake patient in less than 10 minutes. The SCI-Pex study will evaluate the safety and performance of PexyEazy on 35 patients with hemorrhoids grade II and III with a follow-up after 1 week, 3 months and 1 years. Adverse events, pain and other complications will be recorded, quality of life and hemorrhoid symptom questionnaires and clinical examination after 3 months and 1 year will be monitored to evaluate the result after a PexyEazy® procedure.",[104,105,106,35,32],"Hemorrhoids","Hemorrhoids, Internal","Suture; Complications, Infection or Inflammation",[108],"PexyEazy","2025-03-04",{"date":111,"type":47},"2025-03-07",{"date":113,"type":47},"2023-06-15",{"date":115,"type":21},"2026-05-30",{"name":117,"class":54},"Developeration AB",3,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":142},"100541140","clinical-observation-of-drug-retention-enema-in-preventing-acute-radiation-induced-rectal-injury-100541140","NCT06325982","Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury","Clinical Observation of Trolamine Retention Enema in Preventing Acute Radiation-induced Rectal Injury: a Real-world Multicenter Prospective Study","Inclusion Criteria:\n\n* There are clear indications for radiotherapy (pelvic radiotherapy or rectal radiotherapy) according to relevant guidelines;\n* ECOG score 0-1;\n* normal mind, clear consciousness;\n* High compliance;\n* Able to cooperate with the interviewer\n\nExclusion Criteria:\n\n* Poor compliance, unwilling to participate or unable to cooperate with the interviewer;\n* Patients with other intestinal diseases (such as Crohn's disease, rectal ulcer, anal fissure, anal fistula, hemorrhoids, etc.) and perianal diseases;\n* serious heart, brain, liver, kidney disease;\n* Long-term immune dysfunction;\n* Pregnant or lactating women;\n* Patients who terminate treatment for various reasons.",{"count":127,"type":21},200,[24],"The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.",[131,35],"Radiation Injuries","2024-06-04",{"date":134,"type":47},"2024-06-05",{"date":136,"type":21},"2024-06-11",{"date":138,"type":21},"2025-12-31",{"name":140,"class":141},"Fujian Cancer Hospital","OTHER_GOV",1]