A Double Balloon Endoscopic Platform for ESD

NCT03551379 | Completed FDA Device

• 1 other identifier: DD-017
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colon Adenoma; Colon Polyp

Keywords

Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Endoscopic procedure

A double balloon endoscopic platform will be used during an ESD procedure

Device: Double Balloon Endoluminal Platform

Interventions

Double Balloon Endoluminal Platform DEVICE

A DBA platform will be use din this registry study to facilitate ESD

Endoscopic procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with documented complex large intestinal polyps

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lumendi, LLC: lead

Study Sites (1)

Winthrop-NYU Langone

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Stavros Stavropoulos, MD

  Winthrop-NYU Langone Mineola, NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 11, 2018
• Study Start: September 22, 2017
• Primary Completion: March 9, 2018
• Study Completion: September 29, 2018
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)