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.
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…
Contacts
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