Colorectal Adenoma, Colorectal Adenomatous Polyp, Colorectal Neoplasms, Colorectal Polyp
Conditions
Keywords
Colorectal Neoplasms, Colorectal Polyp, Colorectal Adenoma
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.
Interventions
Robotic Transanal Endoluminal Resection of Colorectal Lesions using the ColubrisMX Endoluminal Surgical (ELS) System
Sponsors
Faculdade de Medicina do ABC
ColubrisMX
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of success (%) | 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 (%) | Intraoperative | Percentage of patients with a change in treatment plan to a conventional open or laparoscopic procedure. |
| Estimated blood loss (mL) | Intraoperative | Estimated amount of intraoperative blood loss (up to the point of needing transfusion). |
| Operative time (min) | Intraoperative | Duration from transanal insertion of the robotic flexible overtube to final removal of the flexible overtube from the anal verge. |
| Patients requiring transfusion (%) | Intraoperative | Percentage of patients requiring transfusion during surgery. |
| Complication rate (%) | 60 Days | Percentage of patients having Clavien-Dindo ≥ III intraoperatively or postoperatively at Days 7, 30, or 60. |
| Readmission rate (%) | 60 Days | Percentage of patients with readmission that can be linked to colorectal submucosal dissection. |
| Major Adverse Events (MAE) during the first 60 days | 60 Days | Freedom from procedural-related MAE, defined as a combined clinical endpoint of death or reoperation for failed surgical repair. |
Other
| Measure | Time frame | Description |
|---|---|---|
| En bloc resection rate (%) | Intraoperative | Percentage of samples dissected en bloc, as assessed by the pathologist during postoperative assessment. |
| Rate of positive surgical lateral margins (PSLM) (%) | 60 Days | The number and percentage of subjects with PSLM will be presented separately by subjects undergoing rectal ESD. |
| Rate of perforations repaired operatively (%) | Intraoperative | Rate of perforations requiring repair through open or laparoscopic surgery. |
| Rate of perforations requiring repair through open or laparoscopic surgery (%) | Intraoperative | Rate of perforations requiring repair through open or laparoscopic surgery |
| Rate of delayed perforations (%) | 60 Days | Perforations that present 10 to 24 hours after procedure with clinical signs and symptoms of peritonitis. |
| Adverse Events | 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. |
| Vital Signs | 60 Days | Changes in vital signs from baseline to post-operative Days 7, 30 and 60. |
| Laboratory Assessments | 60 Days | Changes in laboratory parameters and normal/abnormal status changes in laboratory parameters from baseline to post-operative Days 7, 30 and 60. |
Countries
Brazil
Outcome results
None listed