A Double Balloon Endoscopic Platform for ESD

Single Center Prospective Evaluation Utilizing a Double Balloon Accessory Device to Facilitate Complex Endoscopic Polypectomy in Large Intestine

The purpose of this observational study is to record performance of a double balloon endolumenal interventional platform during complex colon polypectomy.

Study Overview

• Status: Completed
• Conditions: Colon Adenoma; Colon Polyp
• Intervention / Treatment: Device: Double Balloon Endoluminal Platform

Detailed Description

Endoscopic removal of Complex colon polyps (benign polyps >=2cm) is a technically challenging procedure. Complex benign polyps have a greater chance of becoming cancerous if not removed.

The DiLumen™ Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope to stabilize it in the large intestine, and facilitates use of the endoscope for optical visualization, diagnosis, and treatment. The device is indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis, and endoscopic treatment.

The device received 510k clearance on Dec 6, 2016. The study will evaluate performance of the device during routine, scheduled, endoscopic polyp removal for these large polyps.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop-NYU Langone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with documented complex large intestinal polyps

Description

Inclusion Criteria:

• Subjects > 18 years of age
• Subjects scheduled for endoscopic removal of suspected complex adenomatous polyps in the large intestine which are sessile or polypoid lesions ≥ 2cm, near the ileocecal valve, dentate line, over a fold, or at a flexure; and or lesions tethered to the colon wall due to previous incomplete resection
• Subjects willing and able to give informed consent
• Subjects who in the opinion of the Principal Investigator have no medical contraindication to endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)

Exclusion Criteria:

• Subjects with a contraindication to colonoscopy, including but not limited to active colitis, perforation, or stricture.
• Subjects with a history of open or laparoscopic colorectal surgery
• Subjects with a history of Inflammatory Bowel Disease (IBD)
• Subjects with a suspected malignancy on polyp assessment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic procedure; A double balloon endoscopic platform will be used during an ESD procedure	Device: Double Balloon Endoluminal Platform; A DBA platform will be use din this registry study to facilitate ESD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to remove the complex polyp endoscopically	Was the lesion(s) able to be removed using the DiLumen Endolumenal Interventional Platform Device [Yes/No]	Duration of Procedure
Time taken for lesion removal	Time for lesion(s) removal with the double balloon device after intervention begins	Intervention start time until Lesion removal
Device or Procedural Adverse Events	Colon perforation, colon mucosal injury, excess bleeding will be recorded	Up to 72 hours

Collaborators and Investigators

• Sponsor: Lumendi, LLC
• Investigators: Principal Investigator: Stavros Stavropoulos, MD, Winthrop-NYU Langone Mineola, NY

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Actual): March 9, 2018
• Study Completion (Actual): September 29, 2018

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 18, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Endoscopic Submucosal Dissection
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: DD-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No