Transanal Resection of Rectal Lesions With the ColubrisMX Endoluminal Surgical System (ELS System)
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- ColubrisMX
- Enrollment
- 26
- Locations
- 3
- Primary Endpoint
- En Bloc Resection Rate (percent)
Overview
Brief Summary
This study is a prospective, single-arm, multi-center, open-label, staged clinical study.
Overall Objective:
- 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).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 22-80 years
- •BMI ≤ 40 kg/m2
- •ASA score ≤ 3
- •Subject agrees to participate in the study by giving signed informed consent
- •Benign lesion that is located ≤ 17 cm from the anal verge, such as adenoma, submucosal nodule, or polyp
- •Lesion size is ≤ 7 cm, with size determined according to the American College of Gastroenterology (ACGE) and the American College of Colon and Rectal Surgeons (ACCRS) guidelines as the dimension of the lesion that is greatest in extent.
Exclusion Criteria
- •Preoperative:
- •Anatomy unsuitable for endoscopic visualization or endoluminal surgery
- •Prior radiation treatment for colorectal cancer
- •Subject diagnosed with ≥ T1 colorectal cancer
- •Subject with distant metastases
- •Subject requiring Total Mesorectal Excision
- •Untreated active infection
- •Vulnerable population (e.g., prisoners, mentally disabled)
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
- •Breastfeeding or pregnant, or intend to become pregnant during the course of the study
Outcomes
Primary Outcomes
En Bloc Resection Rate (percent)
Time Frame: Intraoperative
The En Bloc Resection Rate (percent) is defined as the percentage of target lesions that are excised in a single specimen.
R0 Resection Rate (percent)
Time Frame: 30 days
The R0 Resection Rate (percent) is defined as the percentage of target lesions that have lateral and deep margins that are free of neoplasia under microscopic visualization.
Complication-Free Rate (percent)
Time Frame: 30 days
The Complication-Free Rate (percent) is defined as the percentage of subjects free from complications graded as Clavien-Dindo ≥ III intraoperatively or postoperatively through Day 30.
Secondary Outcomes
- Estimated Blood Loss (mL)(Intraoperative)
- Fecal Incontinence (percent)(30 days)
- Local Recurrence Rate (percent) (subjects with cancer diagnosis only)(5 years)
- Length of Stay (days)(30 days)
- Mortality (percent)(30 days)
- Overall Survival (percent) (subjects with cancer diagnosis only)(5 years)
- Clinical Laboratory Assessments(1 day)
- Conversion-Free Rate (percent)(Intraoperative)
- Adverse Events (percent)(30 days)
- Readmission Rate (percent)(30 days)
- Reoperation Rate (percent)(30 days)
- Subjects Requiring Transfusion (percent)(30 days)
- Rate of Rectal Stricture/Stenosis (percent)(30 days)
- Disease Free Survival (percent) (subjects with cancer diagnosis only)(5 years)
- Vital Signs(30 days)