Status:
ACTIVE_NOT_RECRUITING
Monopolar Current Cutting Knife vs Bipolar RFA Knife
Lead Sponsor:
Baylor College of Medicine
Conditions:
Gastrointestinal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, randomized trial that aims to study the efficacy and clinical outcomes of a novel Bipolar Knife vs. Monopolar Knives on patients who undergo endoscopic submucosal dissection (ES...
Detailed Description
Endoscopic submucosal dissection (ESD) is a novel technique for the removal of advanced colonic polyps with high-risk features. ESD is minimally invasive and allows the removal of colonic adenomatous ...
Eligibility Criteria
Inclusion
- Patient is ≥ 18 years old
- Patient is capable of providing informed consent
- Patient is referred for ESD procedure of gastrointestinal neoplastic lesions
Exclusion
- Patient is \< 18 years old
- Patient refused and/or unable to provide consent
- Patient is a pregnant woman
- Patients with lesions removed with other techniques besides ESD or a modified ESD technique (i.e., EMR or TEM) as defined in the Japan Gastroenterological Endoscopy Society (JGES) guidelines for endoscopic resection of lesions.
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04919824
Start Date
January 25 2022
End Date
October 30 2025
Last Update
August 15 2025
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
Baylor St. Lukes Medical Center (BSLMC)
Houston, Texas, United States, 77030