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PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
NCT06133387 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06133387
The ClinicalTrials.gov registry entry for NCT06133387 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EndoQuest Robotics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06133387 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Arizona, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06133387?
The interventions under investigation include: Endoscopic submucosal dissection using the ELS System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06133387?
This trial is sponsored by EndoQuest Robotics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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