Study of a New Two-Tooth Clip Device to Improve Endoscopic Removal and Closure of Gastrointestinal Stromal Tumors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new two-tooth endoscopic clip used with a clip with line traction method during endoscopic procedures to remove gastrointestinal stromal tumors GIST. This study aims to see if this novel clip improves the efficiency of submucosal dissection compared to standard endoscopic methods. Additionally, the study will assess the clips ability to close tissue defects after tumor removal. Participants will receive one of two treatments either the novel two-tooth clip used with a pre-tied dental line to provide controlled traction during tumor removal, followed by using the clip to close any tissue defects or the standard endoscopic procedure without special traction devices, using standard clips for closure. The novel clip is designed to securely hold the tissue and enhance visibility during the procedure. The study involves a randomized, open-label design comparing these methods. During the study, participants will undergo tumor removal procedures with assigned techniques. Researchers will monitor outcomes such as the efficiency of submucosal dissection within 24 hours, success and time taken for tissue closure, and any adverse events during the procedure and follow-up over three months. Safety and post-procedure recovery will also be assessed. The total study period extends until July 2027, with ongoing evaluations at specified time points.

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