Under way, not recruiting
PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
NCT06133387 · EndoQuest Robotics, Inc. · Updated 22 July 2026
- What is being tested
- Endoscopic submucosal dissection using the ELS System
- For
- Colorectal Lesion; Colorectal Adenoma; Colorectal Polyp; Rectal Lesion; Rectal Adenoma; Rectal Polyp; Sigmoid; Lesion; Sigmoid Colon Polyp
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 22 years and older. About 56 people. The full rules are on the registry page.
- Where
- United States (6 sites)
- When
- Starts or started 13 May 2025, ends Aug 2026. Registered 15 Nov 2023.
- Results
- None posted yet.
In the researchers' words
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon. The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.
Sites
- Mayo ClinicScottsdale, Arizona, United States
- AdventHealthOrlando, Florida, United States
- Brigham and Women's HospitalBoston, Massachusetts, United States
- Cleveland ClinicCleveland, Ohio, United States
- HCA HealthcareHouston, Texas, United States
- Baylor College of MedicineHouston, Texas, United States