NCT06747988

Feasibility and Prospective Study of a Dynamic Traction Device for Use During ESD

Prospective Study Evaluating the Use of a Novel Through - the- Scope Suturing System as a Dynamic Traction Device During ESD: A Feasibility Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The goal of this prospective study at Baylor St. Luke's Medical Center is to investigate the the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric endoscopic submucosal dissection (ESD). The investigators of this study hypothesize that a dynamic traction during ESD can be less traumatic than with other traction devices.

Detailed description

Endoscopic submucosal dissection (ESD) is the mainstay of treatment for complex gastrointestinal polyps, particularly those with a higher risk of superficial submucosal invasion. To facilitate endoscopic dissection, traction is frequently used, particularly in tough locations or when fibrosis is present \[1\]. Traction assisted ESD is particularly attractive when other techniques, such as tunneling or pocket formation, are not effective. Tissue traction can be applied by several methods including gravity, mucosal tension, water pressure, and adjusting the patient's body position \[2\]. Additionally, traction can also be applied using devices such as clip and line, snare, band assisted or using dedicated over-the-scope devices, which can be cumbersome and costly. Despite multiple publications about the efficacy of traction devices in the East, there are few published data from the West \[3\]. Furthermore, an easy to use through the scope (TTS) dynamic traction device has yet to be developed. Recently, a novel TTS helix tack and suture device (X-tack, Apollo Endosurgery, Austin, Tex, USA) was FDA approved to help facilitate closure of post-resection defects \[4\]. However, clinical experience suggests the tack and suture system can also be used as a form of dynamic traction during ESD, similar to effective techniques using traditional suture-pulley systems for countertraction during ESD \[5\]. The traditional suture-pulley system, however, can be cumbersome to assemble as multiple parts are needed to configure it appropriately \[6\]. Additionally, attaching the suture to the designated areas requires use of multiple costly clips and if repositioning is needed, removal of the clip can be traumatic to the tissue. With the novel TTS suture system (X-tack), four tacks are already assembled along one suture line, thus a suture-pulley countertraction system can be employed without having to assemble multiple parts. In addition, the degree and angulation of traction can be altered simply by pulling, releasing or even redirecting the suture towards a different axis, supporting a dynamic traction during ESD. Finally, removal of the tack, if required, can be less traumatic than with other traction devices. Despite its potential advantages, use of X-tack as countertraction pulley system during ESD has not been formally studied. We looked to investigate the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric ESD.

Conditions

• Gastrointestinal Neoplasms

Interventions

Type	Name	Description
DEVICE	Traction Device	After circumferential incision and trimming the submucosa at the incision's edge, dissection is initiated until approximately 20 to 30% of the anal side (for colonic lesions) or oral side (for gastric lesions) of lesion has been dissected leaving a flap of at least 1 cm in length. Once the mucosal flap is created the X-tack device is introduced through the endoscope channel. The first tack is placed on the opposite wall of the lesion, the 2nd and 3rd tack will then be placed next to each other on the mucosal flap portion of the lesion. The 4th tack does not have to be placed but can be used to generate further traction at any time. Clips can be placed along the suture and clipped to the wall at any point to change angulation of traction. The sutures can then be cut and released from the tissue

Timeline

• Start date: 2025-03-30
• Primary completion: 2026-03-30
• Completion: 2026-07-20
• First posted: 2024-12-24
• Last updated: 2024-12-24

Locations

1 site across 1 country: United States