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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient is \>18 years of age

• Patient can provide informed consent

• Patient is referred for resection of precancerous lesions meeting the following criteria:

‣ Mucosal based polyp

⁃ Located gastroesophageal junction (GEJ) or proximal to GEJ

⁃ No previous endoscopic resection attempted (EMR or ESD)

Locations
United States
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Salmaan A Jawaid, MD
Salmaan.Jawaid@bcm.edu
7137980950
Backup
Michael Mercado, B.S
Michael.Mercado@bcm.edu
7137983606
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Treatment arm
Patients who were deemed eligible and signed the consent will undergo the removal of their esophageal precancerous lesion utilizing the novel bipolar knife during their endoscopic submucosal dissection (ESD).
Related Therapeutic Areas
Sponsors
Leads: Baylor College of Medicine
Collaborators: Creo Medical Limited

This content was sourced from clinicaltrials.gov