A Novel Two-Tooth Clip for ESD and EFTR of GIST

May 20, 2026 updated by: Affiliated Hospital to Academy of Military Medical Sciences

Efficacy and Safety of a Novel Two-Tooth Clip-Assisted ESD and EFTR of GIST: A Single-Center, Prospective, Open-Label, Randomized Controlled Study

This study is designed to evaluate the efficacy and safety of a novel two-tooth endoscopic clip, utilized in a "clip with line" traction configuration, during endoscopic resection procedures (ESD and EFTR) of GIST. The novel clip's dual-tooth design is intended to provide a more secure anchor on the lesion, enabling effective counter-traction when combined with a line. The primary aim is to determine if this method improves submucosal dissection efficiency compared to conventional ESD. A secondary aim is to evaluate the performance of the same clip system for full-thickness or mucosal defect closure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endoscopic Submucosal Dissection (ESD) and Endoscopic Full-Thickness Resection (EFTR) are established, minimally invasive techniques for the en-bloc resection of gastrointestinal stromal tumor (GIST). However, a persistent challenge, especially in difficult locations or large lesions, is the lack of sufficient counter-traction, which leads to prolonged procedure times, increased risk of intraoperative bleeding, and potential for incomplete resection due to poor visualization of the submucosal layer. Furthermore, managing large post resection defects or perforations requires reliable and technically feasible endoscopic suturing.

This study introduces a novel two-tooth clip. The device's geometry is hypothesized to provide a stronger, more stable grasp on the targeted tissue compared to standard single-tooth or non-toothed clips. The study will investigate two sequential applications of this clip within a single procedure:

The Traction Phase: A "clip with line" technique will be employed. The novel two-tooth clip will be anchored to the proximal edge of the lesion. A dental line, pre-tied to the clip, will be used by the endoscopist to apply adjustable counter-traction. This is intended to lift the lesion, tauten the submucosal fibers, and clearly expose the dissection plane, thereby simulating the principle of surgical counter-traction.

The Closure Phase: Following lesion resection, the novel two-tooth clip will be utilized to perform a continuous, circumferential closure of the mucosal defect or perforation. The study will assess the technical success rate, time required for complete closure, and the clip's ability to securely approximate tissue layers.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100071
        • Recruiting
        • The Fifth Medical Center of Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 and ≤ 85 years.
  • Patients diagnosed with gastric gastrointestinal lesions clinically indicated for ESD or EFTR.
  • Lesion size between 2 cm and 5 cm in diameter.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Lesions with clear evidence of deep submucosal invasion or distant metastasis precluding curative endoscopic resection.
  • Severe coagulation dysfunction (international normalized ratio >2.0, platelet count <50,000/µL) or ongoing use of dual antiplatelet therapy/anticoagulants that cannot be appropriately bridged or discontinued per guidelines.
  • Severe organ failure (cardiac, renal, hepatic, or respiratory) rendering the patient unsuitable for prolonged sedation or general anesthesia.
  • Pregnancy or lactation.
  • Prior surgical or endoscopic intervention at the target lesion site that results in significant fibrosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Novel Clip-Assisted Traction ESD/EFTR
Patients will undergo ESD or EFTR using the "clip with line" traction method with the novel two-tooth clip. After initial circumferential mucosal incision, the two-tooth clip (with pre-tied line) will be anchored to the lesion. The endoscopist will apply continuous or intermittent traction via the line to optimize the submucosal view. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips in a purse-string configuration.
Device: A Novel Two-Tooth Endoscopic Clip
"Clip with line" traction method with the novel two-tooth clip will be applied in patients undergoing ESD or EFTR. After lesion retrieval, defects requiring closure will be managed using the same novel two-tooth clips.
Active Comparator: Conventional ESD/EFTR
Patients will undergo standard ESD or EFTR without the use of dedicated traction devices. The endoscopist may use transparent cap assistance and positional changes for exposure, which is current standard practice.
Device: Clip
Standard ESD or EFTR without the use of dedicated traction devices will be performed, then using the standard clips for closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Submucosal Dissection Efficiency
Time Frame: 24 hours
The rate of submucosal dissection (measured in mm²/min), calculated from the start of submucosal entry to the completion of lesion removal.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success Rate of Purse-String Closure
Time Frame: 24 hours
Percentage of cases where complete, circumferential mucosal/full-thickness defect closure is achieved using the novel two-tooth clip without conversion to alternative closure devices.
24 hours
Defect Closure Time
Time Frame: 24 hours
Time taken to achieve complete purse-string closure of the post-resection defect.
24 hours
Incidence of Intraoperative Adverse Events
Time Frame: 3 days
  • Rates of immediate perforation (unintended) in both groups during the dissection phase
  • Rates of significant active bleeding requiring emergency hemostasis (aside from planned vessel coagulation) in both groups during the dissection phase
  • Rates of muscularis injury in both groups during the dissection phase
3 days
Post-procedural Outcomes
Time Frame: 3 months
  • Rates of delayed bleeding within 90 days
  • Rates of delayed perforation within 90 days
  • Rates of post-polypectomy electrocoagulation syndrome within 90 days
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Yan Liu, M.D.,Ph.D., Beijing 302 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2026

Primary Completion (Estimated)

April 24, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTC-GIST

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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