NCT06133387 PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
| NCT ID | NCT06133387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | EndoQuest Robotics, Inc. |
| Condition | Colorectal Lesion |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2025-05-13 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 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 endoscopic submucosal dissection. 7. Subject agrees to participate in the study by giving signed informed consent. Preoperative Exclusion Criteria: 1. Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery. 2. Subject has active left-sided inflammatory bowel disease. 3. Subject has an untreated active infection at the time of the procedure. 4. Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled). 5. Subject has a severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (e.g., cancer). 6. Subject is breastfeeding or pregnant or intends to become pregnant during the study. 7. Subject is currently enrolled in or discontinued within the last 30 days from a clinical trial of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 8. Subject with EF ≤ 45, high cardiac or high pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist, as applicable). 9. Subject on preoperative blood thinners, such as coumadin or heparin, that cannot be weaned prior to surgery. 10. Subject is moderately or severely immunocompromised. 11. In the opinion of the Investigator, the subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. Intraoperative Exclusion Criteria (assessed with third-party endoscope): 1. Inadequate bowel prep. 2. Complex anatomical findings not feasible for an endoluminal approach. 3. Anatomical narrowing distal to the lesion site. 4. Lesion not located in the rectum or sigmoid colon. 5. Lesion size \>7 cm (dimension of greatest extent) or occupies \>75% of the colorectal circumference. 6. Lesion demonstrates characteristics indicative of invasive carcinoma, such as failure to lift upon submucosal injection, or any other features that raise the Investigator's suspicion of cancer. Intraoperative Exclusion Criteria (assessed with study device): 7. In the opinion of the Investigator, the subject and/or subject anatomy is not suitable for study device use for any reason. 8. Lesion location not accessible by the study device.
Frequently Asked Questions
Who can join the NCT06133387 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Colorectal Lesion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06133387 currently recruiting?
Yes, NCT06133387 is actively recruiting participants. Visit ClinicalTrials.gov or contact EndoQuest Robotics, Inc. to inquire about joining.
Where is the NCT06133387 trial being conducted?
This trial is being conducted at Scottsdale, United States, Orlando, United States, Boston, United States, Cleveland, United States and 2 additional locations.
Who is sponsoring the NCT06133387 clinical trial?
NCT06133387 is sponsored by EndoQuest Robotics, Inc.. The trial plans to enroll 56 participants.