Clinical trial · Interventional
A Novel Two-Tooth Clip for ESD and EFTR of GIST
Efficacy and Safety of a Novel Two-Tooth Clip-Assisted ESD and EFTR of GIST: A Single-Center, Prospective, Open-Label, Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GIST - Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A Novel Two-Tooth Endoscopic Clip | Device | — | UNRESOLVED |
| Clip | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Novel Clip-Assisted Traction ESD/EFTR
- description
- 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.
- interventionNames
- Device: A Novel Two-Tooth Endoscopic Clip
- type
- ACTIVE_COMPARATOR
- label
- Conventional ESD/EFTR
- description
- 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.
- interventionNames
- Device: Clip
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDZhang 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
- BACKGROUNDHu 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
- BACKGROUNDQiao 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
- BACKGROUNDHu 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