PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System (NCT06133387) | Clinical Trial Compass
RecruitingNot Applicable
PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System
United States56 participantsStarted 2025-05-13
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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).