RECRUITING

Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

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

Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.

Official Title

Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection

Quick Facts

Study Start:2024-10-15
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06476678

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. * Patient is \>18 years of age
  2. * Patient can provide informed consent
  3. * Patient is referred for resection of precancerous lesions meeting the following criteria:
  4. * Mucosal based polyp
  5. * Located gastroesophageal junction (GEJ) or proximal to GEJ
  6. * No previous endoscopic resection attempted (EMR or ESD)
  1. * Patients with International Normalized Ratio (INR) \>1.5 or Platelets \<50,000
  2. * Lesions extending past GEJ
  3. * Subepithelial lesions

Contacts and Locations

Study Contact

Salmaan A Jawaid, MD
CONTACT
7137980950
Salmaan.Jawaid@bcm.edu
Michael Mercado, B.S
CONTACT
7137983606
Michael.Mercado@bcm.edu

Study Locations (Sites)

Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: 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 Date2024-10-15
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-10-15
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Esophageal Neoplasm
  • Esophageal Polyp
  • Endoscopic Submucosal Dissection
  • Bipolar Electrocautery