Colorectal NeoplasmsNCT04192565
A Prospective Investigation of the ColubrisMX ELS System
A study testing ColubrisMX Endoluminal Surgical (ELS) System in people with Colorectal Neoplasms and Colorectal Polyp, run by ColubrisMX at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Polyp, Colorectal Adenoma
- What is being tested?
- ColubrisMX Endoluminal Surgical (ELS) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Sep 2020to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
- Obstructing rectal cancer
- History of inflammatory bowel disease
- Intraoperative
- Existing stricture or anatomical blockage in lower GI tract preventing overtube from reaching desired position.
- Disease is more extensive and not amenable to standard ESD
- Inadequate bowel prep
- Complex anatomical findings not feasible for endoscopic approach
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- ColubrisMX Endoluminal Surgical (ELS) System
- Keywords
- Colorectal Neoplasms, Colorectal Polyp, Colorectal Adenoma
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColubrisMX Endoluminal Surgical (ELS) SystemDevice
Robotic Transanal Endoluminal Resection of Colorectal Lesions using the ColubrisMX Endoluminal Surgical (ELS) System
| Study group | Role | What they receive |
|---|---|---|
| Robotic Transanal Endoluminal Resection | Experimental | Robotic Transanal Endoluminal Resection of Colorectal Lesions Receives: Device: ColubrisMX Endoluminal Surgical (ELS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post-op
Rate of conversions (%)
Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure.
Measured: Intraoperative
Estimated blood loss (mL)
Estimated amount of intraoperative blood loss (up to the point of needing transfusion).
Measured: Intraoperative
Operative time (min)
Duration from transanal insertion of the robotic flexible overtube to final removal of the flexible overtube from the anal verge.
Measured: Intraoperative
Patients requiring transfusion (%)
Percentage of patients requiring transfusion during surgery.
Measured: Intraoperative
Complication rate (%)
Percentage of patients having Clavien-Dindo ≥ III intraoperatively or postoperatively at Days 7, 30, or 60.
Measured: 60 Days
Readmission rate (%)
Percentage of patients with readmission that can be linked to colorectal submucosal dissection.
Measured: 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.
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start13 Sep 2020
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ColubrisMX
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Faculdade de Medicina do ABC
- Responsible party
- Sponsor
- Investigators
- Eduardo Grecco, MD, Principal investigator, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192565
- Sponsor's protocol ID
- CMX-CSP-CS002
- Status last verified
- Sep 2024
- First submitted
- 6 Dec 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Resection of Colorectal Lesions with ColubrisMX Endoluminal Surgical System (ELS for Its Initials in English), Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04192565
- Acronym / sponsor ID
- CMX-CSP-CS002
- Keywords
- Colorectal Neoplasms, Colorectal Polyp, Colorectal Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ColubrisMXIndustry (pharma, biotech, devices)
- Collaborators
- Faculdade de Medicina do ABC
- Study start
- 13 Sep 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Transanal Endoluminal Resection | Experimental | Device: ColubrisMX Endoluminal Surgical (ELS) SystemRobotic Transanal Endoluminal Resection of Colorectal Lesions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColubrisMX Endoluminal Surgical (ELS) SystemRobotic Transanal Endoluminal Resection of Colorectal Lesions using the ColubrisMX Endoluminal Surgical (ELS) System | Device | Robotic Transanal Endoluminal Resection |
Primary outcome
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.
Rate of conversions (%)
Time frame: Intraoperative
Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure.
Estimated blood loss (mL)
Time frame: Intraoperative
Estimated amount of intraoperative blood loss (up to the point of needing transfusion).
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.
Patients requiring transfusion (%)
Time frame: Intraoperative
Percentage of patients requiring transfusion during surgery.
Complication rate (%)
Time frame: 60 Days
Percentage of patients having Clavien-Dindo ≥ III intraoperatively or postoperatively at Days 7, 30, or 60.
Readmission rate (%)
Time frame: 60 Days
Percentage of patients with readmission that can be linked to colorectal submucosal dissection.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Grecco, MD principal investigator
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ColubrisMX Endoluminal Surgical (ELS) System in people with Colorectal Neoplasms and Colorectal Polyp, run by ColubrisMX at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of success (%) (time frame: 24 hours post-op). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.