RecruitingNot Applicable

Traction vs. No Traction in Colonic ESD

United States150 participantsStarted 2023-12-05

Plain-language summary

The goal of this prospective, randomized, controlled trial conducted at Baylor St. Luke's Medical Center is to compare the effectiveness and clinical outcomes of using a traction device in colonic endoscopic submucosal dissection (ESD) to those of using conventional ESD. The investigators of this study hypothesize that use of the traction device will help expedite colonic endoscopic submucosal dissections.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient is ≥ 18 years old.
✓. Patients can provide informed consent.
✓. Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria:

Exclusion criteria

✕. Patient is \< 18 years old.
✕. Patient refused and/or unable to provide consent.
✕. Patient is a pregnant woman.
✕. Lesions with morphology: pedunculated type (Paris IP, Ips).
✕. Appendiceal orifice or IC valve lesions. 6. Patients with lesions removed with other techniques besides ESD (like hybrid ESD or submucosal tunneling technique STER and EMR).

What they're measuring

Dissection speed

Timeframe: Day 1 (procedure day)

Trial details

NCT IDNCT06159634

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Mai Khalaf, MD

713-798-6696 Mai.Khalaf@bcm.edu

View on ClinicalTrials.gov More Gastrointestinal Neoplasm trials