Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
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|ClinicalTrials.gov Identifier: NCT04651764|
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : February 15, 2021
This study is a prospective, single-arm, multi-center, open-label, staged clinical study.
- 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.
Stage 1 Objective:
To evaluate the safety of the ELS System in subjects undergoing specified transanal endoluminal procedures in the rectum (up to 12 cm from the anal verge).
|Condition or disease||Intervention/treatment||Phase|
|Rectal Adenoma Rectal Polyp Rectal Lesion||Device: ColubrisMX Endoluminal Surgical (ELS) System||Not Applicable|
Minimally invasive treatment options for lesions in the rectum and distal colon include endoscopic resection techniques, such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), and transanal surgery, such as transanal endoscopic microsurgery (TEM) and transanal minimally invasive surgery (TAMIS). Endoscopic resection techniques have the flexibility to navigate the curvature of the rectum, however they limit the operator to utilizing one single instrument at a time, which is technically challenging and does not enable application of counter-traction to tissue. The two-handed capability of transanal surgical procedures enables application of counter-traction and suturing of the defect; however, the long, rigid, straight-shafted instruments cannot easily navigate the curvature of the rectum, with visualization and access becoming especially challenging for lesions that extend more than 7-8 cm from the anal verge.
The ColubrisMX Endoluminal Surgical (ELS) System has been developed to assist the colorectal surgeon in performing transanal resection of rectal lesions. The ELS System consists of two main components: the Patient Cart and Surgeon Console. This system gains access to the surgical target by means of a flexible overtube (Colubriscope) that is manually inserted through the anus. The ELS System combines the flexibility of endoscopy to navigate the curvature of endoluminal anatomy with conventional two-handed surgical technique. The Colubriscope has two working channels for two different surgical instruments, and one channel for the videoscope (third-party gastroscope). The surgical instruments are robotically assisted with full triangulation and articulation with up to 7 degrees of freedom in order to improve dexterity in confined spaces. The videoscope is robotically assisted, contained within the Colubriscope, and has adjustable zoom and angulation capabilities. Therefore, the orientation of the camera is decoupled from the orientation of the Colubriscope. This approach improves visualization over that of conventional manual flexible endoscopic procedures, where the camera is fixed to the distal tip of the endoscope and limits visualization based on the orientation of the endoscope.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transanal Resection of Rectal Lesions With the ColubrisMX Endoluminal Surgical System (ELS System)|
|Actual Study Start Date :||October 2, 2020|
|Estimated Primary Completion Date :||March 10, 2021|
|Estimated Study Completion Date :||April 10, 2021|
|Experimental: Robotically assisted transanal endoluminal resection of rectal lesion||
Device: ColubrisMX Endoluminal Surgical (ELS) System
Robotically assisted transanal endoluminal resection of rectal lesion using the ColubrisMX Endoluminal Surgical (ELS) System
- Success (percent) [ Time Frame: Intraoperative ]Success (percent) is defined as the percentage of intended procedures that 1.) are successfully achieved using the ELS System, as determined by the surgeon, and, 2.) do not require conversion to another surgical modality (i.e., laparoscopic or open surgery) to achieve successful completion.
- Freedom from Major Adverse Events (MAE) (percent) [ Time Frame: 30 days ]The Freedom from Major Adverse Events (MAE) (percent) is defined as freedom from procedural-related perforations requiring conversion to a different modality to repair, postoperative bleeding requiring intervention, and local infection requiring intervention past the postoperative antibiotic treatment regimen, through Day 30.
- Adverse Events (percent) [ Time Frame: 30 days ]Data on adverse events will be collected during and after surgery. Each adverse event will be evaluated to determine the severity, relationship to the investigational device, action taken with respect to the investigational device, outcome, etc. Adverse events will be classified as mild, moderate, severe, or life-threatening.
- Readmission Rate (percent) [ Time Frame: 30 days ]The Readmission Rate (percent) is defined as the percentage of subjects with readmission that can be linked to rectal lesion resection requiring an interventional procedure up to 30 days after surgery.
- Reoperation Rate (percent) [ Time Frame: 30 days ]The Reoperation Rate (percent) is defined as the percentage of subjects requiring reoperation that can be linked to rectal lesion resection up to 30 days after surgery.
- Estimated Blood Loss (mL) [ Time Frame: Intraoperative ]Estimated Blood Loss (mL) is the amount of intraoperative blood loss (up to the point of needing transfusion). Estimated Blood Loss will be categorized as Significative, if transfusion is required, or Not Significative, if transfusion is not required.
- Subjects Requiring Transfusion (percent) [ Time Frame: Intraoperative ]Subjects Requiring Transfusion (percent) is defined as the percentage of subjects requiring transfusion during surgery.
- Length of Stay (days) [ Time Frame: 30 days ]The Length of Stay (days) is the amount of days that the subject stays in the hospital related to rectal lesion resection.
- Mortality (percent) [ Time Frame: 30 days ]Mortality (percent) is the percentage of subjects with a mortality from any cause up to 30 days, regardless of whether it was device/procedure-related or not.
- Fecal Incontinence (percent) [ Time Frame: 30 days ]Fecal Incontinence (percent) is the percentage of subjects with clinically significant disturbance to fecal continence from preoperative baseline to postoperative Day 30.
- Rate of Rectal Stricture/Stenosis (percent) [ Time Frame: 30 days ]A proctoscopic exam will be performed to assess rectal stricture/stenosis at 30 days post-procedure. Incidence of rectal stricture/stenosis detected at or before this follow-up visit will be recorded.
- Local Recurrence Rate (percent) [ Time Frame: 5 years ]Subjects with histologically-confirmed cancer will undergo an annual colonoscopy for five years post-procedure to monitor for local recurrence. The rate of local recurrence (percent) will be recorded.
- Disease Free Survival [ Time Frame: 5 years ]Those subjects with histologically-confirmed cancer being followed for five years post-procedure via annual colonoscopy will be monitored for disease-free survival.
- Overall Survival [ Time Frame: 5 years ]Those subjects with histologically-confirmed cancer being followed for five years post-procedure via annual colonoscopy will be monitored for overall survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04651764
|Contact: John Slateremail@example.com|
|United States, Florida|
|EndoSurgical Center of Florida||Recruiting|
|Orlando, Florida, United States, 32825|
|Contact: Annamarie Kondek firstname.lastname@example.org|
|Principal Investigator: Sam Atallah, MD|
|Sub-Investigator: Sergio Larach, MD|
|Sub-Investigator: Elisa Bianchi, MD|
|United States, Nevada|
|University Medical Center of Southern Nevada||Recruiting|
|Las Vegas, Nevada, United States, 89102|
|Contact: Amrita Patel email@example.com|
|Principal Investigator: Ovunc Bardakcioglu, MD|
|Sub-Investigator: Gabriela Doyle, MD|
|United States, Texas|
|Memorial Hermann Southeast Hospital||Recruiting|
|Houston, Texas, United States, 77089|
|Contact: Angielyn Rivera firstname.lastname@example.org|
|Principal Investigator: Todd Wilson, MD|
|Principal Investigator: Erik Askenasy, MD|
|Sub-Investigator: Jeff Van Epps, MD|
|Principal Investigator:||Todd Wilson, MD||University of Texas|
|Principal Investigator:||Erik Askenasy, MD||University of Texas|
|Principal Investigator:||Sam Atallah, MD||University of Central Florida|
|Principal Investigator:||Ovunc Bardakcioglu, MD||University of Nevada, Las Vegas|