PARADIGM - En Bloc Trial With the EndoQuest ELS System

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and effectiveness of the EndoQuest Robotics Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo partial thickness resection 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 and Days 7 and 30.

Detailed Description
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This study will be a prospective, single-arm, 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 partial thickness resection, 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). Any subjects with lesions upstaged to cancer (must be histologically confirmed) post resection using the ELS System will be followed under a separate protocol for 5 years in accordance with NCCN guidelines and evaluated for local recurrence, disease-free survival and overall survival. Clinical data in the final clinical study report will include study results through Day 30. This study will enroll a total of 40 subjects at up to 5 clinical sites in the U.S. No individual site will be permitted to enroll more than 60% (24) of the subjects for the entire IDE study to ensure that a single site does not dominate the results and analysis. In addition to the total of 40 enrolled subjects, each Investigator will enroll 2 lead-in cases. Lead-in cases will be analyzed separately in the final clinical study report.

Official Title
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PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest ELS System

Conditions
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Colorectal Lesions

Intervention / Treatment
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* Device: ELS System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between the ages of 22 to 80 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 Criteria: 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, respectively). 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. Exclusion Criteria (assessed with third-party colonoscope): Inadequate bowel prep. Complex anatomical findings are not feasible for endoluminal approach. Anatomical narrowing distal to the lesion site. Lesion located in the descending colon. Lesion size >7 cm (dimension of greatest extent) or occupies >75% of the colorectal circumference. Exclusion Criteria (assessed with Study device): In the opinion of the Investigator, the subject and/or subject anatomy is not suitable for Study device use for any reason. 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. Lesion is located too distal to be accessed by the Study device (with or without use of a third-party transanal access platform). Lesion located too proximal to be accessed by the Study device.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm, Open-label<br>Subjects will undergo partial thickness resection of benign lesions in the rectum and sigmoid colon using the EndoQuest ELS System. | Device: ELS System<br>* The intended endoluminal resection procedures of the ELS System are partial thickness local excision procedures (resection of a lesion without removing a large colon segment or the entire colon).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En Bloc Resection Rate | The percentage of target lesions across all subjects that are excised in a single specimen on Day 0. | 1 day |