Transanal Resection of Rectal Lesions With the ColubrisMX ELS System (NCT04651764) | Clinical Trial Compass
TerminatedNot Applicable
Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
Stopped: Terminated by ColubrisMX due to its identification of irregularities in the conduct of the trial (not related to clinical safety or effectiveness of the device)
United States26 participantsStarted 2020-09-15
Plain-language summary
This study is a prospective, single-arm, multi-center, open-label, staged clinical study.
Overall Objective:
1. To evaluate the safety and effectiveness of the ELS System in subjects undergoing transanal endoluminal procedures in the rectum and distal colon (up to 17 cm from the anal verge).
2. To validate a program for training surgeons and their teams to successfully use the ELS System.
Who can participate
Age range22 Years – 80 Years
SexALL
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Inclusion criteria
✓. Aged 22-80 years
✓. BMI ≤ 40 kg/m2
✓. ASA score ≤ 3
✓. Subject agrees to participate in the study by giving signed informed consent
✓. Benign lesion that is located ≤ 17 cm from the anal verge, such as adenoma, submucosal nodule, or polyp
✓. Lesion size is ≤ 7 cm, with size determined according to the American College of Gastroenterology (ACGE) and the American College of Colon and Rectal Surgeons (ACCRS) guidelines as the dimension of the lesion that is greatest in extent.
Exclusion criteria
✕. Anatomy unsuitable for endoscopic visualization or endoluminal surgery
✕. Prior radiation treatment for colorectal cancer
✕. Subject diagnosed with ≥ T1 colorectal cancer