Purpose

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).

Conditions

Eligibility

Eligible Ages
Between 22 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Memorial Hermann Southeast Hospital
Houston, Texas 77089
Contact:
Angielyn Rivera
angielyn.r.rivera@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
ColubrisMX

Study Contact

John Slater
512-541-5852
john.slater@colubrismx.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.