Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

About this trial

The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.

Eligibility criteria

Qualifiers

Patient suffering from 30-60 mm colonic polyps with indication of ESD

Male or female patients aged > 18 years' old

Patients able to fill in questionnaires written in Italian

Disqualifiers

Failure of endoscopic resection

Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)

Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)

Polyp inside the ileo-cecal valvula.

Trial design

Treatments tested in this trial

  • TTS suturing system

Treatment groups

66 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators