Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM

A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM (LR) as a Modified Colonic Overtube

Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in 2010 and worldwide has become the third most common cancer and second leading cause of cancer related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer and endoscopic removal of the polyps prevents development of colon cancer.

Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically difficult to perform, labor intensive, time consuming and carries higher risks of complications (bleeding, perforations, etc.). The purpose of this study is to determine the effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is hypothesized that the use of this modified colonic overtube will simplify colonoscopic removal of difficult polyps, decrease the time needed to complete the procedure and decrease the rate of complications post endoscopic removal of large and flat colonic.

Study Overview

• Status: Completed
• Conditions: Colonic Adenomatous Polyps
• Intervention / Treatment: Device: LumenR Retractor; Device: Removal without overtube

Detailed Description

All patients presented for endoscopic removal of difficult colonic polyps will be eligible for the study based on inclusion and exclusion criteria. All procedures will be explained by the Investigator and all subjects undergoing treatment will review and sign the study Informed Consent prior to the procedure. Each subject will be randomly assigned to two groups, Group 1 and Group 2, and according to the assignment, the LumenR Retractor will be used or not during the procedure.

Patient preparation, including intravenous sedation, will be the same for both Groups.

Group 1: A traditional pediatric colonoscope will be advanced into the colon and endoscopic removal of the polyp will be performed.

Group 2: A traditional pediatric colonoscope with a modified overtube preloaded over the endoscope will be advanced into the colon. After the polyp is reached, the overtube will be advanced forward and expanded around the polyp. Endoscopic removal of the polyp with the use of commercially available graspers and biopsy forceps inserted through the overtube working channels will be performed.

At the conclusion of each procedure, the size of the polyp, total procedure time, amount of CO2 used for colonic insufflation, amount of fluid used for submucosal injection, and any complications, including bleeding and perforation, will be recorded. At the end of the procedure, if necessary, the resulting mucosal defect after lesion removal will be closed with endoscopic clips or endoscopic suturing device.

After completion of procedure, all subjects will be recovered according to standard recovery room protocol and then discharged home or admitted to hospital if necessary. Subjects will be followed at 24 hours, and 10 days post treatment and any complications post endoscopic removal of the polyp will be recorded. At 3 months post treatment, all subjects will have repeat colonoscopy to evaluate post polypectomy site and remove any residual polypoid tissue found.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Mercy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Colonic polyps 2cm in size or greater
• Subject 17 to 90 years of age
• Female subjects must have negative pregnancy test within last 24 hours timeline, and no intentions to become pregnant or be sterilized during participation in study.

Exclusion Criteria:

• Colonic polyps less than 2cm in size
• Under 17 or over 90 years of age
• Unwilling to consent or comply with protocol requirements
• Uncorrectable bleeding disorders (INR more than 1.5; platlet count less than 50,000)
• Allergy to materials from which the device is constructed- Polyvinyl Chloride, Nitinol, Watershed, Polycarbonate, and Polytetrafluoroethylene
• Received experimental drug or device within 3 months prior to start of study
• Treatment with an investigational drug or medical device during the study period
• Female subjects that are pregnant or lactating or intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study
• Psychological condition, or under treatment for any condition which, in the opinion of the Investigator and/or consulting physician(s), would constitute an unwarranted risk

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LumenR Retractor; Endoscopic removal of polyp using modified overtube LumenR Retractor	Device: LumenR Retractor; Polyp removal using LumenR Retractor Modified overtube
Active Comparator: Removal without overtube; Endoscopic removal of polyp without overtube	Device: Removal without overtube; Endoscopic removal of polyp without overtube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of successful en block removal of polyps	1 year
Length of time required to remove large and flat colonic polyps	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of carbon dioxide (CO2) gas for colonic insufflation used during procedure		Day 1
Amount of solution used for submucosal injection to lift the polyp		Day 1
Presence of residual polypoid tissue at the site of polypectomy	A colonoscopy will be performed to evaluate the polypectomy site and remove any residual polypoid tissue if found.	3 months
Safety assessment based on the number of delayed adverse events and complications		10 days
Rate of bleeding during polypectomy	Estimate of rate of bleeding during endoscopic removal of difficult colonic polyps	1 year
Rate of perforation during polypectomy	To compare rate of perforation during endoscopic removal of difficult colonic polyps	1 year

Collaborators and Investigators

• Sponsor: Mercy Medical Center
• Investigators: Principal Investigator: Sergey V Kantsevoy, M.D., Ph.D., Mercy Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 26, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 31, 2014

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Intestinal Polyps; Adenoma; Polyps; Colonic Polyps; Adenomatous Polyps
• Other Study ID Numbers: MMC 2012-64