NCT04192565

A Prospective Investigation of the ColubrisMX ELS System

Endoscopic Resection of Colorectal Lesions with ColubrisMX Endoluminal Surgical System (ELS for Its Initials in English), Prospective Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: ColubrisMX · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Colorectal Polyp
• Colorectal Adenoma
• Colorectal Adenomatous Polyp

Interventions

Type	Name	Description
DEVICE	ColubrisMX Endoluminal Surgical (ELS) System	Robotic Transanal Endoluminal Resection of Colorectal Lesions using the ColubrisMX Endoluminal Surgical (ELS) System

Timeline

• Start date: 2020-09-13
• Primary completion: 2021-04-15
• Completion: 2021-04-15
• First posted: 2019-12-10
• Last updated: 2024-09-19

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated device study