Clinical trial NCT03551379: A Double Balloon Endoscopic Platform for ESD
Official title: Single Center Prospective Evaluation Utilizing a Double Balloon Accessory Device to Facilitate Complex Endoscopic Polypectomy in Large Intestine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Adenoma
Colon Polyp
Keywords: Endoscopic Submucosal Dissection
Lead sponsor: Lumendi, LLC
Sponsor class: INDUSTRY
First posted: 2018-06-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with documented complex large intestinal polyps

Brief 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.

Eligibility 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

Primary outcomes:
measure: Ability to remove the complex polyp endoscopically
timeFrame: Duration of Procedure
measure: Time taken for lesion removal
timeFrame: Intervention start time until Lesion removal
measure: Device or Procedural Adverse Events
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop-NYU Langone
state: New York
Study officials:
affiliation: Winthrop-NYU Langone Mineola, NY
name: Stavros Stavropoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: