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

NCT06443047 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-05-02

No results posted yet for this study

Summary

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.

Conditions

  • Precancerous Lesion of Colon

Interventions

DEVICE

TTS suturing system

The use of TTS suturing system could allow a quick, complete endoscopic closure of colonic post-ESD defects, providing relevant clinical and medico-economic benefits.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Alessandro Repici, Prof. · IRCCS Humanitas Research Hospital - Rozzano 20089, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06443047 on ClinicalTrials.gov