A Prospective Investigation of the ColubrisMX ELS System (NCT04192565) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Investigation of the ColubrisMX ELS System
Brazil10 participantsStarted 2020-09-13
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
✕
What they're measuring
1
Rate of success (%)
Timeframe: 24 hours post-op
2
Rate of conversions (%)
Timeframe: Intraoperative
3
Estimated blood loss (mL)
Timeframe: Intraoperative
4
Operative time (min)
Timeframe: Intraoperative
5
Patients requiring transfusion (%)
Timeframe: Intraoperative
6
Complication rate (%)
Timeframe: 60 Days
7
Readmission rate (%)
Timeframe: 60 Days
8
Major Adverse Events (MAE) during the first 60 days