Stopped early
Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
NCT04651764 · ColubrisMX · Updated 26 Oct 2024
- What is being tested
- ColubrisMX Endoluminal Surgical (ELS) System
- For
- Rectal Adenoma; Rectal Polyp; Rectal Lesion
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 22 years to 80 years. About 26 people. The full rules are on the registry page.
- Where
- United States (3 sites)
- When
- Starts or started 15 Sept 2020, ends 29 June 2021. Registered 3 Dec 2020.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- EndoSurgical Center of FloridaOrlando, Florida, United States
- University Medical Center of Southern NevadaLas Vegas, Nevada, United States
- Memorial Hermann Southeast HospitalHouston, Texas, United States