PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
EndoQuest Robotics, Inc.
Summary
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.
Description
This study will be a prospective, single treatment, multi-center, open-label clinical study. The objective of this study is to evaluate the safety and effectiveness of the ELS System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon (up to 7 cm in size and up to 75% of the colorectal circumference). The safety and effectiveness outcomes will be assessed intraoperatively and post…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Preoperative Inclusion Criteria: 1. Subject is ≥22 years at the time of consent. 2. Subject has a BMI ≤ 50 kg/m2. 3. Subject has an ASA score of ≤ 3. 4. Subject has benign lesion(s) of the rectum or sigmoid colon, such as adenoma (with low- or high-grade dysplasia), neuroendocrine tumor, or other type of polyp as assessed by the most recent colonoscopy/flexible sigmoidoscopy. 5. Subject has lesion ≤ 7 cm in size (dimension of greatest extent) and ≤ 75% of the colorectal circumference as assessed by the most recent colonoscopy/flexible sigmoidoscopy. 6. Subject is eligible for standard endosco…
Interventions
- DeviceEndoscopic submucosal dissection using the ELS System
All subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.
Locations (6)
- Mayo ClinicScottsdale, Arizona
- AdventHealthOrlando, Florida
- Brigham and Women's HospitalBoston, Massachusetts
- Cleveland ClinicCleveland, Ohio
- HCA HealthcareHouston, Texas
- Baylor College of MedicineHouston, Texas