Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transanal Resection of Rectal Lesions With the ColubrisMX ELS System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04651764
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
ColubrisMX

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.

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

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Subjects Requiring Transfusion (percent) [ Time Frame: Intraoperative ]
    Subjects Requiring Transfusion (percent) is defined as the percentage of subjects requiring transfusion during surgery.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 22-80 years
  2. BMI ≤ 40 kg/m2
  3. ASA score ≤ 3
  4. Subject agrees to participate in the study by giving signed informed consent
  5. Benign lesion that is located ≤ 12 cm from the anal verge, such as adenoma, submucosal nodule, or polyp
  6. Lesion size is ≤ 2.7 cm, with size determined according to the American College of Gastroenterology (ACGE) and the American College of Colon and Rectal Surgeons (ACCRS) guidelines as either the length or the width of the lesion (whichever is larger).
  7. Subject reviewed and approved by local oncology committee to undergo robotic procedure.

Exclusion Criteria:

Preoperative:

  1. Anatomy unsuitable for endoscopic visualization or endoluminal surgery
  2. Previous rectal or sigmoid resection procedure.
  3. Prior radiation treatment for colorectal cancer
  4. Subject diagnosed with ≥ T1 colorectal cancer
  5. Subject with distant metastases
  6. Subject requiring Total Mesorectal Excision
  7. Untreated active infection
  8. Vulnerable population (e.g., prisoners, mentally disabled)
  9. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
  10. Breastfeeding or pregnant, or intend to become pregnant during the course of the study
  11. Currently enrolled in or discontinued within the last 30 days from a clinical trial of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  12. In the opinion of the Investigator, the subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
  13. Subjects with immunosuppression drugs (chemotherapy) due to an increase potential infection and poor healing
  14. Subjects with a high cardiac or pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist)
  15. Preoperative blood thinner i.e., coumadin or heparin.
  16. Obstructing rectal cancer
  17. History of inflammatory bowel disease

Intraoperative:

  1. Existing stricture or anatomical blockage in lower GI tract preventing Colubriscope from reaching desired position.
  2. Inadequate bowel prep.
  3. Complex anatomical findings not feasible for endoluminal approach.
  4. Confirmation that lesion is located further than the intended use of the ELS System for Stage 1 of this study (past 12 cm from the anal verge).

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: John Slater 512-541-5852 john.slater@colubrismx.com

Locations
Layout table for location information
United States, Florida
EndoSurgical Center of Florida Recruiting
Orlando, Florida, United States, 32825
Contact: Annamarie Kondek       aekondek@gmail.com   
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       amrita.patel@unlv.edu   
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       angielyn.r.rivera@uth.tmc.edu   
Principal Investigator: Todd Wilson, MD         
Principal Investigator: Erik Askenasy, MD         
Sub-Investigator: Jeff Van Epps, MD         
Sponsors and Collaborators
ColubrisMX
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: ColubrisMX
ClinicalTrials.gov Identifier: NCT04651764    
Other Study ID Numbers: CMX-CSP-CS003
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by ColubrisMX:
Rectal Adenoma
Rectal Polyp
Rectal Lesion
Local Excision
Robotic Surgery
Transanal Surgery
Transanal Minimally Invasive Surgery
Endoluminal Surgery
Resection
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms