A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue (NCT07727564) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue
60 participantsStarted 2026-07-31
Plain-language summary
This clinical trial employs a prospective, multicenter, randomized, single-blind, parallel-controlled, non-inferiority design with a positive comparator device. The study aims to assess the safety and efficacy of the disposable endoscopic closing device manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd. when applied for gastrointestinal tissue closing and hemostasis.
The trial group will undergo closure and hemostasis using disposable endoscopic closing device.
The control group will undergo closure and hemostasis using metal clips, or metal clips in combination with nylon loops.
This device is clinically indicated for patients requiring closure of gastrointestinal tissue.
Primary effectiveness endpoint: composite clinical success rate. Secondary effectiveness endpoints: endoscopic procedure time. Secondary safety endpoints: incidence of adverse events, incidence of serious adverse events, and incidence of device malfunctions.
Vital signs and hemoglobin changes will be closely monitored during the 24-hour period following the procedure. At 7 days postoperatively, a follow-up assessment (either outpatient or by telephone) will be performed. At 30 days postoperatively, the final outpatient follow-up visit will be conducted.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. No restrictions on gender or race.
. Intraoperative endoscopic confirmation of gastrointestinal tissue defects or lesions (≤50 mm) requiring closure, such as post-endoscopic resection mucosal defects, gastrointestinal fistulas, active bleeding, gastrointestinal perforation, colonic diverticular bleeding, etc.
. The local anatomy, tissue thickness, and inflammatory status of the target lesion and its surrounding tissues are assessed by the endoscopist as sufficient to withstand the mechanical tensile and anchoring forces exerted by the device (screws or clips).
. Patients possess good communication skills and compliance, are willing to cooperate in completing a 30-day clinical follow-up observation, and have an expected survival of more than 6 months.
. Voluntary participation in this clinical trial, with written informed consent approved by the Ethics Committee signed by the patient or their legally authorized representative.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Presence of severe coagulation disorders, specifically defined as: platelet count \< 50 × 10⁹/L, or international normalized ratio (INR) \> 2.0, or partial thromboplastin time (PTT) \> 2× the upper limit of normal, and not correctable by blood product transfusion or medication prior to the procedure.
. Concomitant high-risk conditions such as severe organ dysfunction, including: severe hepatic or renal insufficiency (AST or ALT \> 3× upper limit of normal; serum creatinine \> 3× upper limit of normal), heart failure classified as NYHA Class III-IV, or presence of impaired consciousness, or profound hemorrhagic shock (systolic blood pressure \< 90 mmHg and heart rate \> 110 bpm) without successful resuscitation.
. Continuous use of systemic anticoagulants (e.g., warfarin, novel oral anticoagulants) or dual antiplatelet agents within 7 days prior to the procedure (with the exception of aspirin monotherapy), and inability to safely discontinue or implement bridging therapy before and after the procedure.
. Known allergy to medical-grade surgical stainless steel (containing metallic components such as nickel, cobalt, chromium), polypropylene polymeric materials, or anesthetic/sedative medications required for endoscopic procedures.
. Female patients who are pregnant or breastfeeding.
. Current participation in another drug or medical device clinical trial, with less than 30 days having elapsed since the last withdrawal from the previous trial, or presence of any other factors that, in the investigator's opinion, may interfere with the evaluation of trial outcomes.
. Conditions deemed by the investigator as inappropriate for the patient's enrollment.