NCT03551379

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Lumendi, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Colon Adenoma
• Colon Polyp

Interventions

Type	Name	Description
DEVICE	Double Balloon Endoluminal Platform	A DBA platform will be use din this registry study to facilitate ESD

Timeline

• Start date: 2017-09-22
• Primary completion: 2018-03-09
• Completion: 2018-09-29
• First posted: 2018-06-11
• Last updated: 2019-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study