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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

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

• 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:

⁃ A- Lesions with prior resection or with scar at any size. B- Granular lateral spreading tumors (GLST) more than 3 cm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign.

Locations
United States
Texas
Baylor College of Medicine
RECRUITING
Houston
Baylor St. Lukes Medical Center (BSLMC)
RECRUITING
Houston
Contact Information
Primary
Mai Khalaf, MD
Mai.Khalaf@bcm.edu
713-798-6696
Backup
Michael Mercado, BS
Michael.Mercado@bcm.edu
713-798-3606
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 150
Treatments
Experimental: ESD with traction device
ESD of target lesion will be performed with the assistance of a traction device.
Active_comparator: Control arm
ESD of target lesion will be performed without the use of a traction device
Related Therapeutic Areas
Sponsors
Collaborators: Micro-Tech Endoscopy USA
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov