NCT04651764

Transanal Resection of Rectal Lesions With the ColubrisMX ELS System

Transanal Resection of Rectal Lesions With the ColubrisMX Endoluminal Surgical System (ELS System)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: ColubrisMX · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, multi-center, open-label, staged clinical study. Overall Objective: 1. To evaluate the safety and effectiveness of the ELS System in subjects undergoing transanal endoluminal procedures in the rectum and distal colon (up to 17 cm from the anal verge). 2. To validate a program for training surgeons and their teams to successfully use the ELS System.

Detailed description

Endoscopic Mucosal Resection (EMR) is the current standard treatment for non-malignant colorectal polyps in the United States. Large colorectal polyps are most often removed piecemeal when using EMR, as en-bloc resection becomes increasingly challenging with increasing lesion size. The major drawback of EMR is its low en-bloc resection rate. The piecemeal nature of the resection hinders margin assessment, which consequently results in low R0 resection rates and causes uncertainty regarding the appropriate treatment plan for the patient going forward. This outcome results in surveillance colonoscopies at shorter intervals to evaluate for recurrence, which in turn, increases patient anxiety and poses a burden on the healthcare system. Endoscopic Submucosal Dissection (ESD) enables en bloc resection and therefore improved histopathological assessment of margins and has been reported to have highly improved R0 resection rates when compared with EMR. ESD is a common treatment option for large colorectal lesions in Asia; however, the technical difficulty and steep learning curve, which are mainly attributed to the lack of traction and countertraction capability, have resulted in low adoption of ESD in the United States. The ColubrisMX Endoluminal Surgical (ELS) System represents a marked advancement in the removal of non-malignant colorectal lesions. Robotic-assisted instrumentation with bimanual dexterity allows for application of traction and counter-traction and closure of the defect via suturing, and enables the technically challenging, single-handed ESD procedure to be conducted via a two-handed, robotic-assisted, transanal endoluminal surgical approach. The ELS System consists of two main components: the Patient Cart and the Surgeon Console. This system gains access by means of a flexible overtube (Colubriscope) that can be manually inserted up to 17 cm into the distal colon. The ELS System provides full visualization of the surgical site and the ability to manipulate up to two surgical instruments and a robotic-assisted third-party flexible endoscope (Olympus GIF-XP190), which is referred to as the "videoscope". The ELS Surgical Instruments are robotically assisted with full triangulation and articulation with up to 7 degrees of freedom to provide enhanced dexterity in narrow endoluminal anatomy.

Conditions

• Rectal Adenoma
• Rectal Polyp
• Rectal Lesion

Interventions

Type	Name	Description
DEVICE	ColubrisMX Endoluminal Surgical (ELS) System	Robotically assisted transanal endoluminal resection of rectal lesion using the ColubrisMX Endoluminal Surgical (ELS) System

Timeline

• Start date: 2020-09-15
• Primary completion: 2021-06-29
• Completion: 2021-06-29
• First posted: 2020-12-03
• Last updated: 2024-10-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study