Evaluating a new surgical system for removing benign colorectal lesions

PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System

This study is testing a new surgical system to see if it can safely and effectively remove non-cancerous growths from the rectum and lower part of the colon.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: EndoQuest Robotics, Inc. (Industry-sponsored)
• Locations: 6 sites (Scottsdale, Arizona and 5 other locations)
• Trial ID: NCT06133387 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the Endoluminal Surgical (ELS) System for performing endoscopic submucosal dissection (ESD) on benign lesions in the rectum and sigmoid colon. Participants will undergo procedures to remove lesions up to 7 cm in size, with outcomes evaluated during and after the procedure at specified intervals. The study will categorize subjects based on their pathology results and resection success, allowing for tailored follow-up care. The trial is multi-center and open-label, involving several prominent medical institutions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 80 with benign lesions in the rectum or sigmoid colon that meet specific size and health criteria.

Not a fit: Patients with unsuitable anatomy for endoscopic procedures or those with active infections or inflammatory bowel disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive option for the removal of benign colorectal lesions, potentially improving patient outcomes and recovery times.

How similar studies have performed: Other studies using similar endoscopic techniques have shown promise, suggesting that this approach may be effective, though this specific application with the ELS System is relatively novel.

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.

Where this trial is running

Scottsdale, Arizona and 5 other locations

• Mayo Clinic — Scottsdale, Arizona, United States (Recruiting)
• AdventHealth — Orlando, Florida, United States (Recruiting)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (Completed)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• HCA Healthcare — Houston, Texas, United States (Recruiting)
• Baylor College of Medicine — Houston, Texas, United States (Recruiting)

Conditions Colorectal Lesion; Colorectal Adenoma; Colorectal Polyp; Rectal Lesion; Rectal Adenoma; Rectal Polyp; Sigmoid; Lesion