A Prospective Investigation of the ColubrisMX ELS System

September 13, 2024 updated by: ColubrisMX

Endoscopic Resection of Colorectal Lesions with ColubrisMX Endoluminal Surgical System (ELS for Its Initials in English), Prospective Clinical Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Endoscopic resection of small polyps is performed routinely through conventional outpatient colonoscopy. Larger polyps or incipient tumors can be excised with endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). These minimally invasive procedures have been shown to be viable alternatives to conventional surgical resections with less risk of complications, shorter hospital stay and lower costs.

Both flexible endoscopic and open/laparoscopic surgical approaches have procedural limitations that can have considerable impact on patient care. Traditional endoscopic tools have technical inadequacies that may inhibit the physician's ability to complete more complex tasks consistent with a surgical technique. Conversely, a traditional open or laparoscopic surgical approach involves increased risk of complications (such as surgical site infection), increased pain and blood loss, longer recovery, and surgical scars. The objective of this clinical study is to assess the safety and efficacy of the ColubrisMX Endoluminal Surgical (ELS) System, a new robotic technology designed to assist the physician with precision, flexibility, and control during endoluminal removal of colorectal lesions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Santo André, Sao Paulo, Brazil, 09060-870
        • Faculdade de Medicina do ABC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA

All of the following criteria must be present to be eligible for the study:

  1. Aged 18-75 years
  2. BMI ≤ 35 kg/m2
  3. Patient agrees to participate in the study by giving signed informed consent
  4. Benign lesions of the rectum, such as adenoma, submucosal nodule, or polyp
  5. Mucosal neoplasm
  6. Eligible to undergo standard endoscopic submucosal dissection.
  7. Patient reviewed and approved by Local Oncology Committee to undergo robotic procedure.

EXCLUSION CRITERIA

Patients will be excluded from the study if any of the following criteria are present:

Preoperative

  1. Anatomy unsuitable for endoscopic visualization or endoluminal surgery
  2. Extensive previous surgery in the lower GI tract
  3. Prior radiation treatment for colorectal cancer
  4. Patient with distant metastases
  5. Untreated active infection
  6. Vulnerable population (e.g., prisoners, mentally disabled)
  7. Severe concomitant illness (i.e., cancer) that drastically shortens life expectancy or increases risk of therapeutic interventions
  8. Breastfeeding or pregnant, or intend to become pregnant during the course of the study
  9. 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
  10. 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.
  11. Patients with immunosuppression drugs (chemotherapy) due to an increase potential infection and poor healing
  12. Patients with a high cardiac or pulmonary risk (these patients require clearance from a cardiologist and pulmonologist)
  13. Preoperative blood thinner i.e., coumadin or heparin.
  14. Obstructing rectal cancer
  15. History of inflammatory bowel disease

Intraoperative

  1. Existing stricture or anatomical blockage in lower GI tract preventing overtube from reaching desired position.
  2. Disease is more extensive and not amenable to standard ESD
  3. Inadequate bowel prep
  4. Complex anatomical findings not feasible for endoscopic approach

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robotic Transanal Endoluminal Resection
Robotic Transanal Endoluminal Resection of Colorectal Lesions
Device: ColubrisMX Endoluminal Surgical (ELS) System
Robotic Transanal Endoluminal Resection of Colorectal Lesions using the ColubrisMX Endoluminal Surgical (ELS) System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of success (%)
Time Frame: 24 hours post-op
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 (%)
Time Frame: Intraoperative
Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure.
Intraoperative
Estimated blood loss (mL)
Time Frame: Intraoperative
Estimated amount of intraoperative blood loss (up to the point of needing transfusion).
Intraoperative
Operative time (min)
Time Frame: Intraoperative
Duration from transanal insertion of the robotic flexible overtube to final removal of the flexible overtube from the anal verge.
Intraoperative
Patients requiring transfusion (%)
Time Frame: Intraoperative
Percentage of patients requiring transfusion during surgery.
Intraoperative
Complication rate (%)
Time Frame: 60 Days
Percentage of patients having Clavien-Dindo ≥ III intraoperatively or postoperatively at Days 7, 30, or 60.
60 Days
Readmission rate (%)
Time Frame: 60 Days
Percentage of patients with readmission that can be linked to colorectal submucosal dissection.
60 Days
Major Adverse Events (MAE) during the first 60 days
Time Frame: 60 Days
Freedom from procedural-related MAE, defined as a combined clinical endpoint of death or reoperation for failed surgical repair.
60 Days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
En bloc resection rate (%)
Time Frame: Intraoperative
Percentage of samples dissected en bloc, as assessed by the pathologist during postoperative assessment.
Intraoperative
Rate of positive surgical lateral margins (PSLM) (%)
Time Frame: 60 Days
The number and percentage of subjects with PSLM will be presented separately by subjects undergoing rectal ESD.
60 Days
Rate of perforations repaired operatively (%)
Time Frame: Intraoperative
Rate of perforations requiring repair through open or laparoscopic surgery.
Intraoperative
Rate of perforations requiring repair through open or laparoscopic surgery (%)
Time Frame: Intraoperative
Rate of perforations requiring repair through open or laparoscopic surgery
Intraoperative
Rate of delayed perforations (%)
Time Frame: 60 Days
Perforations that present 10 to 24 hours after procedure with clinical signs and symptoms of peritonitis.
60 Days
Adverse Events
Time Frame: 60 Days
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users, or other persons, whether related to the investigational medical device.
60 Days
Vital Signs
Time Frame: 60 Days
Changes in vital signs from baseline to post-operative Days 7, 30 and 60.
60 Days
Laboratory Assessments
Time Frame: 60 Days
Changes in laboratory parameters and normal/abnormal status changes in laboratory parameters from baseline to post-operative Days 7, 30 and 60.
60 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ColubrisMX

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Faculdade de Medicina do ABC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eduardo Grecco, MD, Faculdade de Medicina do ABC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMX-CSP-CS002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

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