Clinical trial NCT04192565: A Prospective Investigation of the ColubrisMX ELS System
Official title: Endoscopic Resection of Colorectal Lesions with ColubrisMX Endoluminal Surgical System (ELS for Its Initials in English), Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Colorectal Polyp
Colorectal Adenoma
Colorectal Adenomatous Polyp
Keywords: Colorectal Neoplasms
Colorectal Polyp
Colorectal Adenoma
Lead sponsor: ColubrisMX
Sponsor class: INDUSTRY
Collaborators: name: Faculdade de Medicina do ABC
First posted: 2019-12-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of success (%)
timeFrame: 24 hours post-op
measure: Rate of conversions (%)
timeFrame: Intraoperative
measure: Estimated blood loss (mL)
timeFrame: Intraoperative
measure: Operative time (min)
timeFrame: Intraoperative
measure: Patients requiring transfusion (%)
timeFrame: Intraoperative
measure: Complication rate (%)
timeFrame: 60 Days
measure: Readmission rate (%)
timeFrame: 60 Days
measure: Major Adverse Events (MAE) during the first 60 days
timeFrame: 60 Days
Secondary outcomes:
Other outcomes:
measure: En bloc resection rate (%)
timeFrame: Intraoperative
measure: Rate of positive surgical lateral margins (PSLM) (%)
timeFrame: 60 Days
measure: Rate of perforations repaired operatively (%)
timeFrame: Intraoperative
measure: Rate of perforations requiring repair through open or laparoscopic surgery (%)
timeFrame: Intraoperative
measure: Rate of delayed perforations (%)
timeFrame: 60 Days
measure: Adverse Events
timeFrame: 60 Days
measure: Vital Signs
timeFrame: 60 Days
measure: Laboratory Assessments
timeFrame: 60 Days
Locations:
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: Sao Paulo
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Eduardo Grecco, MD
role: PRINCIPAL_INVESTIGATOR
References: