A Prospective Investigation of the ColubrisMX ELS System

Status Completed

Clinical Trial Summary

This study is a prospective, single-arm, open-label, multi-center, feasibility study to evaluate the safety and efficacy of ColubrisMX ELS System in patients undergoing transanal endoluminal procedures, specifically colorectal Endoscopic Submucosal Dissection.

Clinical Trial Description

Current treatment options for colorectal lesions most often include flexible endoscopy or open/laparoscopic surgery. Both approaches have procedural limitations that can have considerable impact on patient care. Traditional endoscopic tools have technical inadequacies, ones that 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 chance of complications (such as surgical site infection), more pain & blood loss, longer recovery and larger surgical scars. This clinical study proposes the use of an endoluminal robotic technology that is designed to improve patient outcomes for colorectal lesions. This system allows physicians to perform many types of complex endoluminal procedures with more precision, flexibility, and control than that of conventional endoscopic, open or laparoscopic surgical techniques. Using this robotic system, surgeons can perform delicate and complex endoluminal procedures that may have been difficult or impossible with other methods, and could have positive impact on outcomes, recovery time, and overall patient care. Patients will undergo the procedure using the ColubrisMX ELS System, and its initial safety and efficacy outcomes will be assessed intraoperatively and postoperatively at discharge and days 7 and 30. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04192565
Study type	Interventional
Source	ColubrisMX
Contact
Status	Completed
Phase	N/A
Start date	September 9, 2020
Completion date	March 29, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04552093` - Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)	Phase 2/Phase 3
Completed	`NCT05178745` - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Recruiting	`NCT03561350` - Detect Microsatellite Instability Status in Blood Sample of Advanced Colorectal Cancer Patients by Next-Generation Sequencing
Recruiting	`NCT06128798` - Effect of Preoperative Immunonutrition Versus Standard Oral Nutrition in Patient Undergoing Colorectal Surgery.	N/A
Recruiting	`NCT03602677` - Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage	N/A
Completed	`NCT03631407` - Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046)	Phase 2
Withdrawn	`NCT04192929` - Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy	N/A
Recruiting	`NCT03042091` - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery	Early Phase 1
Completed	`NCT02889679` - Underwater Resection of Non-pedunculated Colorectal Lesions	N/A
Terminated	`NCT02842580` - De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer	Phase 2
Completed	`NCT02564835` - Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer	N/A
Completed	`NCT02503696` - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)	N/A
Completed	`NCT02149108` - Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)	Phase 3
Completed	`NCT02599103` - The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects	N/A
Completed	`NCT01669109` - Hatha Yoga for Patients With Colorectal Cancer	N/A
Completed	`NCT01719926` - Phase I Platinum Based Chemotherapy Plus Indomethacin	Phase 1
Recruiting	`NCT01428752` - Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer	N/A
Completed	`NCT01978717` - General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer	N/A
Completed	`NCT01877018` - Colorectal Cancer Screening in Primary Care	N/A
Terminated	`NCT00950820` - Study to Evaluate the Effects of Panitumumab if Combined With Chemotherapy for 2nd Treatment of Colorectal Cancer	Phase 2