A Double Balloon Endoscopic Platform for ESD
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|ClinicalTrials.gov Identifier: NCT03551379|
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment|
|Colon Adenoma Colon Polyp||Device: Double Balloon Endoluminal Platform|
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|
|Actual Enrollment :||15 participants|
|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|
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
- 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]
- 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
- Device or Procedural Adverse Events [ Time Frame: Up to 72 hours ]Colon perforation, colon mucosal injury, excess bleeding will be recorded
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
|United States, New York|
|Mineola, New York, United States, 11501|
|Principal Investigator:||Stavros Stavropoulos, MD||Winthrop-NYU Langone Mineola, NY|