RecruitingNot ApplicableNCT06133387

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

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

Sponsor

EndoQuest Robotics, Inc.

Enrollment

56 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 22 Years

Inclusion Criteria7

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.

Exclusion Criteria19

Subject anatomy is unsuitable for endoscopic visualization or endoluminal surgery.
Subject has a history of 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.
Lesion size >7 cm (dimension of greatest extent) or occupies >75% of the colorectal circumference.
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.
In the opinion of the Investigator, the subject and/or subject anatomy is not suitable for study device use for any reason.
Lesion location not accessible by the study device.

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Interventions

DEVICEEndoscopic 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.