Transanal Resection of Rectal Lesions With the ColubrisMX ELS System

NCT04651764 | Terminated FDA Device

• 1 other identifier: CMX-CSP-CS003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

This study is a prospective, single-arm, multi-center, open-label, staged clinical study. Overall Objective:

1. 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. 2.To validate a program for training surgeons and their teams to successfully use the ELS System.

Conditions

Rectal Adenoma; Rectal Polyp; Rectal Lesion

Keywords

Rectal Adenoma; Rectal Polyp; Rectal Lesion; Endoscopic Submucosal Dissection; Robotic Surgery; Endoluminal Surgery; Transanal Minimally Invasive Surgery; Transanal Surgery; Resection

Outcome Measures

Primary Outcomes (3)

• En Bloc Resection Rate (percent)

  The En Bloc Resection Rate (percent) is defined as the percentage of target lesions that are excised in a single specimen.

  Intraoperative

• R0 Resection Rate (percent)

  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.

  30 days

• Complication-Free Rate (percent)

  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.

  30 days

Secondary Outcomes (15)

• Conversion-Free Rate (percent)

  Intraoperative

• Adverse Events (percent)

  30 days

• Readmission Rate (percent)

  30 days

• Reoperation Rate (percent)

  30 days

• Estimated Blood Loss (mL)

  Intraoperative

Study Arms (1)

Robotically assisted transanal endoluminal resection of rectal lesion

EXPERIMENTAL

Device: ColubrisMX Endoluminal Surgical (ELS) System

Interventions

ColubrisMX Endoluminal Surgical (ELS) System DEVICE

Robotically assisted transanal endoluminal resection of rectal lesion using the ColubrisMX Endoluminal Surgical (ELS) System

Robotically assisted transanal endoluminal resection of rectal lesion

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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.
• Subjects with immunosuppression drugs (chemotherapy) due to an increased potential for infection and poor healing
• Subjects with a high cardiac or pulmonary risk (these subjects require clearance from a cardiologist and pulmonologist)
• Subjects on preoperative blood thinners, i.e., coumadin or heparin, that cannot be weaned prior to surgery

Sponsors & Collaborators

• ColubrisMX: lead

Study Sites (3)

EndoSurgical Center of Florida

Orlando, Florida, 32825, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Memorial Hermann Southeast Hospital

Houston, Texas, 77089, United States

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: December 3, 2020
• Study Start: September 15, 2020
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

US (3)