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NCT06133387 · ClinicalTrials.gov registry record · NA
PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
A NA study of Colorectal Adenoma and Colorectal Polyp, sponsored by EndoQuest Robotics.
- Recruiting
- Registry status
- NA
- Development phase
- 56
- Enrollment target
- 5
- Study locations
NCT06133387: Recruiting NA study of Colorectal Adenoma and Colorectal Polyp, sponsored by EndoQuest Robotics.
NCT06133387 is a NA study of Colorectal Adenoma and Colorectal Polyp that is actively recruiting participants, run by EndoQuest Robotics. The registered enrollment target is 56 participants, below the 1,424-participant average among 8 other Colorectal Adenoma trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06133387, a NA study of Colorectal Adenoma and Colorectal Polyp, is actively recruiting participants, sponsored by EndoQuest Robotics.
- RECRUITING
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
The percentage of target lesions across all subjects that are excised in a single specimen.
Conditions Studied
Interventions
- DEVICE Endoscopic submucosal dissection using the ELS System
Study Locations (5)
Arizona
- Mayo Clinic - Scottsdale
Florida
- AdventHealth - Orlando
Massachusetts
- Brigham and Women's Hospital - Boston
Ohio
- Cleveland Clinic - Cleveland
Texas
- HCA Healthcare - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2025-05-13 |
| Est. Completion | 2026-06 |
| Phase | NA |
What NCT06133387 shows while recruiting
NCT06133387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,424-participant average among 8 other Colorectal Adenoma trials with a reported enrollment target (96% lower).
The record links to 8 conditions, with Colorectal Adenoma appearing as the primary indexed condition, and to 1 intervention - of which Endoscopic submucosal dissection using the ELS System is the first listed.
NCT06133387 lists 5 locations in 5 states (Arizona, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06133387 about?
NCT06133387 is a clinical study titled "PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System". 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...
What is the current status of trial NCT06133387?
This trial is currently recruiting. It is a NA study. The enrollment target is 56 participants. The study started on 2025-05-13. Estimated completion is 2026-06.
What conditions does trial NCT06133387 study?
This clinical trial studies the following conditions: Colorectal Adenoma, Colorectal Polyp, Colorectal Lesion, Rectal Lesion, Rectal Adenoma.
What interventions are being tested in trial NCT06133387?
The interventions under investigation include: Endoscopic submucosal dissection using the ELS System (DEVICE).
Who is sponsoring clinical trial NCT06133387?
This trial is sponsored by EndoQuest Robotics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06133387 being conducted?
This trial has 5 study locations across Arizona, Florida, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06133387's enrollment target sits among peer trials
56 7th of 8 higher than 2 of 8 other Colorectal Adenoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Adenoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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