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Transanal Resection of Rectal Lesions With the ColubrisMX ELS System

NCT04651764 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-10-26

No results posted yet for this study

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.

Conditions

  • Rectal Adenoma
  • Rectal Polyp
  • Rectal Lesion

Interventions

DEVICE

ColubrisMX Endoluminal Surgical (ELS) System

Robotically assisted transanal endoluminal resection of rectal lesion using the ColubrisMX Endoluminal Surgical (ELS) System

Sponsors & Collaborators

  • ColubrisMX

    lead INDUSTRY

Principal Investigators

  • Todd Wilson, MD · University of Texas

  • Erik Askenasy, MD · University of Texas

  • Sam Atallah, MD · University of Central Florida

  • Ovunc Bardakcioglu, MD · University of Nevada, Las Vegas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2021-06-29
Completion
2021-06-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04651764 on ClinicalTrials.gov