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A Prospective Investigation of the ColubrisMX ELS System

NCT04192565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-09-19

No results posted yet for this study

Summary

This study is a prospective, single-arm, open-label, multi-center, feasibility study to evaluate the safety and efficacy of the ColubrisMX ELS System in patients undergoing transanal endoluminal procedures, specifically colorectal Endoscopic Submucosal Dissection.

Conditions

  • Colorectal Neoplasms
  • Colorectal Polyp
  • Colorectal Adenoma
  • Colorectal Adenomatous Polyp

Interventions

DEVICE

ColubrisMX Endoluminal Surgical (ELS) System

Robotic Transanal Endoluminal Resection of Colorectal Lesions using the ColubrisMX Endoluminal Surgical (ELS) System

Sponsors & Collaborators

  • Faculdade de Medicina do ABC

    collaborator OTHER

  • ColubrisMX

    lead INDUSTRY

Principal Investigators

  • Eduardo Grecco, MD · Faculdade de Medicina do ABC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-13
Primary Completion
2021-04-15
Completion
2021-04-15
FDA Device
Yes

Countries

  • Brazil

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 NCT04192565 on ClinicalTrials.gov