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 range
22 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.