Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04651764
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-08-31
First Post:
2020-10-22
Brief Title:
Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
Sponsor:
ColubrisMX
Organization:
ColubrisMX
Study Overview
Official Title:
Transanal Resection of Rectal Lesions With the ColubrisMX Endoluminal Surgical System ELS System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None