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A Double Balloon Endoscopic Platform for ESD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03551379
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Lumendi, LLC

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

Condition or disease Intervention/treatment
Colon Adenoma Colon Polyp 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.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Single Center Prospective Evaluation Utilizing a Double Balloon Accessory Device to Facilitate Complex Endoscopic Polypectomy in Large Intestine
Actual Study Start Date : September 22, 2017
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : September 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. Ability to remove the complex polyp endoscopically [ Time Frame: Duration of Procedure ]
    Was the lesion(s) able to be removed using the DiLumen Endolumenal Interventional Platform Device [Yes/No]

  2. Time taken for lesion removal [ Time Frame: Intervention start time until Lesion removal ]
    Time for lesion(s) removal with the double balloon device after intervention begins

  3. Device or Procedural Adverse Events [ Time Frame: Up to 72 hours ]
    Colon perforation, colon mucosal injury, excess bleeding will be recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with documented complex large intestinal polyps
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551379


Locations
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United States, New York
Winthrop-NYU Langone
Mineola, New York, United States, 11501
Sponsors and Collaborators
Lumendi, LLC
Investigators
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Principal Investigator: Stavros Stavropoulos, MD Winthrop-NYU Langone Mineola, NY
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Responsible Party: Lumendi, LLC
ClinicalTrials.gov Identifier: NCT03551379    
Other Study ID Numbers: DD-017
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Lumendi, LLC:
Endoscopic Submucosal Dissection
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms