PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System

Recruiting N/A Interventional Study
Colorectal Lesion Colorectal Adenoma Colorectal Polyp Rectal Lesion Rectal Adenoma Rectal Polyp Sigmoid; Lesion Sigmoid Colon Polyp
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
22 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
56 (estimated)
Sponsor
EndoQuest Robotics, Inc. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
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 t…
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