A Double Balloon Endoscopic Platform for ESD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-22

Study Completion Date

2018-09-29

Brief Summary

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

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Detailed Description

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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

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Colon Adenoma Colon Polyp

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Endoscopic procedure

A double balloon endoscopic platform will be used during an ESD procedure

Double Balloon Endoluminal Platform

Intervention Type DEVICE

A DBA platform will be use din this registry study to facilitate ESD

Interventions

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Double Balloon Endoluminal Platform

A DBA platform will be use din this registry study to facilitate ESD

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No