PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System

NCT06133387 | Recruiting FDA Device

• 1 other identifier: CIP-0001-Rev F
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 6

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.

Conditions

Colorectal Lesion; Colorectal Adenoma; Colorectal Polyp; Rectal Lesion; Rectal Adenoma; Rectal Polyp; Sigmoid; Lesion; Sigmoid Colon Polyp

Keywords

Rectal Lesion; Sigmoid Lesion

Outcome Measures

Primary Outcomes (2)

• En Bloc Resection Rate

  The percentage of target lesions across all subjects that are excised in a single specimen.

  On Day 0 (day of procedure)

• ESD-Related Complication-Free Rate

  The percentage of subjects free from study device-related bleeding and perforation complications intraoperatively and postoperatively through Day 30.

  From enrollment to Day 30.

Secondary Outcomes (2)

• R0 Resection Rate

  On Day 0 (day of procedure)

• Conversion-Free Rate

  On Day 0 (day of procedure)

Study Arms (2)

Arm 1

EXPERIMENTAL

* Subjects with benign final pathology and R0 resection is achieved; or, * Subjects with benign (but not pre-cancerous) final pathology without R0 resection. Subjects in Arm 1 will complete the study after Day 30.

Device: Endoscopic submucosal dissection using the ELS System

Arm 2

EXPERIMENTAL

* Subjects with final pathology that is upstaged to cancer; or, * Subjects with benign (and pre-cancerous) final pathology without R0 resection. Subjects in Arm 2 will undergo 5-year follow-up to assess long-term oncological outcomes including local recurrence, disease-free survival and overall survival.

Device: Endoscopic submucosal dissection using the ELS System

Interventions

Endoscopic submucosal dissection using the ELS System DEVICE

All subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.

Arm 1; Arm 2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥22 years at the time of consent.
• Subject has a BMI ≤ 50 kg/m2.
• Subject has an ASA score of ≤ 3.
• 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.
• 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.
• Subject is eligible for standard endoscopic submucosal dissection.
• Subject agrees to participate in the study by giving signed informed consent.

You may not qualify if:

• Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.
• Subject has active left-sided inflammatory bowel disease.
• Subject has an untreated active infection at the time of the procedure.
• Subject is considered part of a vulnerable population (e.g., prisoners, mentally disabled).
• Subject has a severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (e.g., cancer).
• Subject is breastfeeding or pregnant or intends to become pregnant during the study.
• 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.
• Subject with EF ≤ 45, high cardiac or high pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist, as applicable).
• Subject on preoperative blood thinners, such as coumadin or heparin, that cannot be weaned prior to surgery.
• Subject is moderately or severely immunocompromised.
• 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.
• Inadequate bowel prep.
• Complex anatomical findings not feasible for an endoluminal approach.
• Anatomical narrowing distal to the lesion site.
• Lesion not located in the rectum or sigmoid colon.

Sponsors & Collaborators

• EndoQuest Robotics, Inc.: lead

Study Sites (6)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

RECRUITING

AdventHealth

Orlando, Florida, 32803, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

COMPLETED

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

HCA Healthcare

Houston, Texas, 77004, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: May 13, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (6)