RECRUITING

Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

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, single centre, 1:1, Post Market, randomized controlled, Investigator Initiated trial, is to compare the feasibility, safety efficacy, and clinical outcomes of colonic endoscopic submucosal dissection (ESD) utilizing a novel rigidizing overtube called Pathfinder® Endoscope Overtube (Neptune Medical, Burlingame California, USA) device in comparison to conventional ESD. The research team hypothesize that with utilizing a novel rigidizing overtube the procedure time including dissection speed and closure time will be faster due to higher scope stability and greater control over the scope tip. Subsequently, the investigators anticipate lower immediate or delayed adverse events.

Official Title

Prospective Single Centre, Post Market, Randomized Controlled Trial to Demonstrate Feasibility, Safety and Efficacy, of a Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

Quick Facts

Study Start:2024-06-04
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06134687

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:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is ≥ 22 years old.
  2. * Patients can provide written informed consent.
  3. * Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria:
  1. * Patient refused and/or unable to provide written informed consent.
  2. * Patient is a pregnant or nursing woman.
  3. * Lesions with morphology: pedunculated type (Paris Ip, Ips).
  4. * Lesions located within the sigmoid colon or rectum.
  5. * Lesions involving appendiceal orifice or ileocecal valve

Contacts and Locations

Study Contact

Michael Mercado, BS
CONTACT
713-798-3606
Michael.Mercado@bcm.edu
Sara Al Yasin, BS
CONTACT
713-798-2308
Sara.AlYasin@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 Date2024-06-04
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2024-06-04
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Endoscopic Submucosal Dissection

Additional Relevant MeSH Terms

  • Gastrointestinal Neoplasm