RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06133387

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.

Ages Eligible for Study:22 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is between the ages of 22 to 80 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.	1. Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery. 2. Subject has a history of 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. 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. 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.

Inclusion Criteria

Exclusion Criteria

1. Subject is between the ages of 22 to 80 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.

1. Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.
2. Subject has a history of 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.
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.
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.

Contacts and Locations

Study Locations (Sites)

Mayo Clinic

Scottsdale, Arizona, 85259

United States

AdventHealth

Orlando, Florida, 32803

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

HCA Healthcare

Houston, Texas, 77004

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-04

Study Completion Date2026-03

Study Record Updates

Study Start Date2025-04

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

Rectal Lesion
Sigmoid Lesion

Additional Relevant MeSH Terms

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