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

NCT07581977 | Recruiting

• 1 other identifier: TTC-GIST
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GIST - Gastrointestinal Stromal Tumor

Keywords

GIST; ESD; EFTR; two-tooth clips

Outcome Measures

Primary Outcomes (1)

• Submucosal Dissection Efficiency

  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 Outcomes (4)

• Technical Success Rate of Purse-String Closure

  24 hours

• Incidence of Intraoperative Adverse Events

  3 days

• Defect Closure Time

  24 hours

• Post-procedural Outcomes

  3 months

Study Arms (2)

Novel Clip-Assisted Traction ESD/EFTR

EXPERIMENTAL

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

Conventional ESD/EFTR

ACTIVE COMPARATOR

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

Interventions

Clip DEVICE

Standard ESD or EFTR without the use of dedicated traction devices will be performed, then using the standard clips for closure.

Conventional ESD/EFTR

A Novel Two-Tooth Endoscopic Clip DEVICE

"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.

Novel Clip-Assisted Traction ESD/EFTR

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, 100071, China

RECRUITING

Related Publications (4)

• Zhang K, Hu S, Zhang X, Min M, Liu Y. The retained-bridge traction strategy: a novel solution for secure defect closure following duodenal endoscopic full-thickness resection. Endoscopy. 2026 Mar;58(S 01):E374-E375. doi: 10.1055/a-2804-6504. Epub 2026 Mar 9. No abstract available.

  PMID: 41802768 BACKGROUND

• Hu S, Chu J, Qiao Y, Shen W, Tang A, Zhang H, Zhang X, Min M, Liu Y. A novel enhanced two-tooth clip for reliable defect closure endoscopically: An ex vivo comparative and in vivo feasibility study. Surg Endosc. 2026 Jan;40(1):864-874. doi: 10.1007/s00464-025-12450-5. Epub 2025 Dec 12.

  PMID: 41388104 BACKGROUND

• Qiao Y, Hu S, Shen W, Tang A, Zhang X, Zhang H, Min M, Liu Y. Novel endoscopic gastric purse-string suture device for weight management in a porcine model (with video). Endosc Int Open. 2025 Apr 15;13:a25399167. doi: 10.1055/a-2539-9167. eCollection 2025.

  PMID: 40309063 BACKGROUND

• Hu S, Qiao Y, Zhang X, Min M, Liu Y. Transrectal endoscopic resection of intraperitoneal gastrointestinal stromal tumor facilitated by incidental segmental absence of intestinal musculature. Endoscopy. 2025 Dec;57(S 01):E945-E946. doi: 10.1055/a-2665-7697. Epub 2025 Aug 20. No abstract available.

  PMID: 40834899 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Yan Liu, M.D.,Ph.D.

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Min, M.D., Ph.D.

CONTACT

+86-010-66947473; minmin823@sina.com

Yan Liu, M.D., Ph.D.

CONTACT

+86-010-66947473; 13911798288@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): April 24, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)