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

April 9, 2026 updated by: EndoQuest Robotics, Inc.

PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be a prospective, single treatment, multi-center, open-label clinical study. The objective of this study is to evaluate the safety and effectiveness of the ELS System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. 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 (up to 7 cm in size and up to 75% of the colorectal circumference).

The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge, Day 7 (-2 +7 days) and Day 30 (-7 +14 days).

Subjects with lesions resected using the study device will be allocated into two different study arms:

Arm 1:

  • Subjects with benign final pathology and R0 resection is achieved; or,
  • Subjects with benign (but not pre-cancerous) final pathology without R0 resection.

Arm 2:

  • Subjects with final pathology that is upstaged to cancer; or,
  • Subjects with benign (and pre-cancerous) final pathology without R0 resection.

Subjects in Arm 1 will complete the study after Day 30. Arm 1 subjects in which R0 resection was not achieved should receive routine care, including any additional treatment as needed at the discretion of the physician, even if occurring after study exit at Day 30. Any non-study-related care of Arm 1 subjects occurring after study exit may be performed by the Investigator or transferred to another physician at the discretion of the Investigator and will not be collected for this trial.

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.

To ensure a total of 50 subjects are included in the final analysis, the study may enroll up to 56 subjects at up to 6 clinical sites in the U.S. No individual site will be permitted to enroll more than 60% of the subjects in the final data set to ensure that a single site does not dominate the results and analysis. Enrollment will end when 50 subjects have completed 30-day follow-up or the maximum enrollment number has been reached, whichever occurs first.

In addition to the total number of enrolled subjects, each Investigator will enroll up to 2 lead-in cases. Lead-in cases will be analyzed separately in the final clinical study report.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Norio Fukami, MD
    • Florida
      • Orlando, Florida, United States, 32803
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Completed
        • Brigham and Women's Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Joshua Sommovilla, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Mohamed Othman, MD
        • Contact:
      • Houston, Texas, United States, 77004
        • Recruiting
        • HCA Healthcare
        • Principal Investigator:
          • Eric Haas, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
  • 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
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.
Experimental: Arm 2
  • 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
En Bloc Resection Rate
Time Frame: On Day 0 (day of procedure)
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
Time Frame: From enrollment to Day 30.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 Resection Rate
Time Frame: On Day 0 (day of procedure)
The percentage of target lesions across all subjects that are resected with lateral and deep margins free of residual disease under microscopic visualization.
On Day 0 (day of procedure)
Conversion-Free Rate
Time Frame: On Day 0 (day of procedure)
The percentage of intended resections that do not require conversion to achieve successful completion of the resection.
On Day 0 (day of procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EndoQuest Robotics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0001-Rev F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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