A Double Balloon Endoscopic Platform for ESD

Colon Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551379
• Other study ID #: DD-017
• Status: Completed
• Start date: September 22, 2017
• Est. completion date: September 29, 2018

Study information

• Verified date: August 2019
• Source: Lumendi, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 29, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colon Polyp

Intervention

Device:
• Double Balloon Endoluminal Platform
A DBA platform will be use din this registry study to facilitate ESD

Locations

Country	Name	City	State
United States	Winthrop-NYU Langone	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
Lumendi, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time taken for lesion removal	Time for lesion(s) removal with the double balloon device after intervention begins	Intervention start time until Lesion removal
Primary	Device or Procedural Adverse Events	Colon perforation, colon mucosal injury, excess bleeding will be recorded	Up to 72 hours