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

NCT02051465 | Completed DMC

• 1 other identifier: MMC 2012-64
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonic Adenomatous Polyps

Outcome Measures

Primary Outcomes (2)

• Percentage of successful en block removal of polyps

  1 year

• Length of time required to remove large and flat colonic polyps

  Day 1

Secondary Outcomes (6)

• 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

  3 months

• Safety assessment based on the number of delayed adverse events and complications

  10 days

• Rate of bleeding during polypectomy

  1 year

Study Arms (2)

LumenR Retractor

EXPERIMENTAL

Endoscopic removal of polyp using modified overtube LumenR Retractor

Device: LumenR Retractor

Removal without overtube

ACTIVE COMPARATOR

Endoscopic removal of polyp without overtube

Device: Removal without overtube

Interventions

LumenR Retractor DEVICE

Polyp removal using LumenR Retractor Modified overtube

LumenR Retractor

Removal without overtube DEVICE

Endoscopic removal of polyp without overtube

Removal without overtube

Eligibility Criteria

• Age: 17 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Medical Center: lead

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21215, United States

Location

Study Officials

• Sergey V Kantsevoy, M.D., Ph.D.

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Therapeutic Endoscopy

Study Record Dates

• First Submitted: January 26, 2014
• First Posted: January 31, 2014
• Study Start: May 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 21, 2018

Record last verified: 2018-08

Locations

US (1)