Health TrialsbyHealthPanel

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

ConditionGIST - Gastrointestinal Stromal Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAffiliated Hospital to Academy of Military Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Clip

    Device

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Novel Clip-Assisted Traction ESD/EFTRExperimental treatment 1 intervention
Group B: Conventional ESD/EFTRActive comparator 1 intervention

Trial outcomes

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.

Time frame
24 hours

Secondary outcomes

1

Technical Success Rate of Purse-String Closure

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.

Time frame
24 hours
2

Incidence of Intraoperative Adverse Events

* 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

Time frame
3 days
3

Defect Closure Time

Time taken to achieve complete purse-string closure of the post-resection defect.

Time frame
24 hours
4

Post-procedural Outcomes

* Rates of delayed bleeding within 90 days * Rates of delayed perforation within 90 days * Rates of post-polypectomy electrocoagulation syndrome within 90 days

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Affiliated Hospital to Academy of Military Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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