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

NCT07727564 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-27

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Bleeding
  • Gastrointestinal Neoplasms

Interventions

DEVICE

disposable endoscopic closing device

Using disposable endoscopic closing device 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

Sponsors & Collaborators

  • Jiangsu Vedkang Medical Science and Technology Co., Ltd

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-06-30
Completion
2027-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727564 on ClinicalTrials.gov