RECRUITING

Traction vs. No Traction in Colonic ESD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparison of the Efficacy of Using a Traction Device in Colonic Endoscopic Submucosal Dissection Versus Conventional ESD: A Randomized Clinical Trial

Quick Facts

Study Start:2023-12-05
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06159634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient is ≥ 18 years old.
  2. 2. Patients can provide informed consent.
  3. 3. Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria:
  1. 1. Patient is \< 18 years old.
  2. 2. Patient refused and/or unable to provide consent.
  3. 3. Patient is a pregnant woman.
  4. 4. Lesions with morphology: pedunculated type (Paris IP, Ips).
  5. 5. 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).

Contacts and Locations

Study Contact

Mai Khalaf, MD
CONTACT
713-798-6696
Mai.Khalaf@bcm.edu
Michael Mercado, BS
CONTACT
713-798-3606
Michael.Mercado@bcm.edu

Principal Investigator

Mohamed Othman, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Baylor College of Medicine
Houston, Texas, 77030
United States
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Mohamed Othman, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-12-05
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Endoscopic Submucosal Dissection
  • Endoscopic Traction

Additional Relevant MeSH Terms

  • Gastrointestinal Neoplasm