A Prospective Investigation of the ColubrisMX ELS System

NCT04192565 | Completed DMC FDA Device

• 1 other identifier: CMX-CSP-CS002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Colorectal Neoplasms; Colorectal Polyp; Colorectal Adenoma

Outcome Measures

Primary Outcomes (8)

• Rate of success (%)

  Percentage of patients with no conversion during surgery and no major complications (Clavien-Dindo ≥ III complication rating) for 24 hours post-op.

  24 hours post-op

• Rate of conversions (%)

  Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure.

  Intraoperative

• Estimated blood loss (mL)

  Estimated amount of intraoperative blood loss (up to the point of needing transfusion).

  Intraoperative

• Operative time (min)

  Duration from transanal insertion of the robotic flexible overtube to final removal of the flexible overtube from the anal verge.

  Intraoperative

• Patients requiring transfusion (%)

  Percentage of patients requiring transfusion during surgery.

  Intraoperative

• Complication rate (%)

  Percentage of patients having Clavien-Dindo ≥ III intraoperatively or postoperatively at Days 7, 30, or 60.

  60 Days

• Readmission rate (%)

  Percentage of patients with readmission that can be linked to colorectal submucosal dissection.

  60 Days

• Major Adverse Events (MAE) during the first 60 days

  Freedom from procedural-related MAE, defined as a combined clinical endpoint of death or reoperation for failed surgical repair.

  60 Days

Other Outcomes (8)

• En bloc resection rate (%)

  Intraoperative

• Rate of positive surgical lateral margins (PSLM) (%)

  60 Days

• Rate of perforations repaired operatively (%)

  Intraoperative

Study Arms (1)

Robotic Transanal Endoluminal Resection

EXPERIMENTAL

Robotic Transanal Endoluminal Resection of Colorectal Lesions

Device: ColubrisMX Endoluminal Surgical (ELS) System

Interventions

ColubrisMX Endoluminal Surgical (ELS) System DEVICE

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

Robotic Transanal Endoluminal Resection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the following criteria must be present to be eligible for the study:
• Aged 18-75 years
• BMI ≤ 35 kg/m2
• Patient agrees to participate in the study by giving signed informed consent
• Benign lesions of the rectum, such as adenoma, submucosal nodule, or polyp
• Mucosal neoplasm
• Eligible to undergo standard endoscopic submucosal dissection.
• Patient reviewed and approved by Local Oncology Committee to undergo robotic procedure.

You may not qualify if:

• Patients will be excluded from the study if any of the following criteria are present:
• Preoperative
• Anatomy unsuitable for endoscopic visualization or endoluminal surgery
• Extensive previous surgery in the lower GI tract
• Prior radiation treatment for colorectal cancer
• Patient with distant metastases
• Untreated active infection
• Vulnerable population (e.g., prisoners, mentally disabled)
• Severe concomitant illness (i.e., cancer) that drastically shortens life expectancy or increases risk of therapeutic interventions
• Breastfeeding or pregnant, or intend to become pregnant during the course of the study
• Currently enrolled in or discontinued within the last 30 days from a clinical trial of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• In the opinion of the Investigator, the patient is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
• Patients with immunosuppression drugs (chemotherapy) due to an increase potential infection and poor healing
• Patients with a high cardiac or pulmonary risk (these patients require clearance from a cardiologist and pulmonologist)
• Preoperative blood thinner i.e., coumadin or heparin.

Sponsors & Collaborators

• ColubrisMX: lead
• Faculdade de Medicina do ABC: collaborator

Study Sites (1)

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-870, Brazil

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Eduardo Grecco, MD

  Faculdade de Medicina do ABC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: September 13, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)