A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue

A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal Tissue: a Prospective, Multicenter, Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Neoplasms; Gastrointestinal Bleeding
• Intervention / Treatment: Device: disposable endoscopic closing device; Device: metal clips, or metal clips in combination with nylon loops

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Project Manager; Phone Number: +86 15161150617; Email: hongjun.shao@vedkang.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. No restrictions on gender or race.
2. 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.
3. 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).
4. 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.
5. 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:

1. 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.
2. 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.
3. 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.
4. 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.
5. Female patients who are pregnant or breastfeeding.
6. 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.
7. Conditions deemed by the investigator as inappropriate for the patient's enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Using disposable endoscopic closing device to closure and hemostasis	Device: disposable endoscopic closing device; Using disposable endoscopic closing device to closure and hemostasis
Active Comparator: Using metal clips, or metal clips in combination with nylon loops to closure and hemostasis	Device: metal clips, or metal clips in combination with nylon loops; Using metal clips, or metal clips in combination with nylon loops to closure and hemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness : composite clinical success rate. Composite clinical success = Technical success AND 7-day post-procedural clinical success AND 30-day post-procedural clinical success.	Technical success is defined as the successful achievement of complete closure of the target lesion or immediate hemostasis following a single application of the randomly assigned investigational or control device during the initial endoscopic procedure, without the need for any unassigned adjunctive closure devices not originally allocated. 7-day post-procedural clinical successis defined as the absence of any clinically significant delayed bleeding event occurring from the completion of the initial endoscopic procedure up to post-operative day 7 (±1 day). 30-day post-procedural clinical success is defined as the patient concurrently meeting all of the following criteria from the completion of the initial endoscopic procedure up to post-operative day 30 (±3 days): Absence of clinically significant delayed bleeding; Absence of perforation; Absence of salvage interventions; Absence of attributable mortality	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Endoscopic procedure time.	2 hours
Adverse Event Rate	30 days
Serious Adverse Event Rate	30 days
Device Malfunction Rate	2 hours

Collaborators and Investigators

• Sponsor: Jiangsu Vedkang Medical Science and Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: July 19, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Gastrointestinal Hemorrhage
• Other Study ID Numbers: VDKPF-HCD-046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No