A Double Balloon Endoscopic Platform for ESD

Study Overview
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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.

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.

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

Conditions
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Colon Adenoma, Colon Polyp

Intervention / Treatment
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* Device: Double Balloon Endoluminal Platform


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic procedure<br>A double balloon endoscopic platform will be used during an ESD procedure | Device: Double Balloon Endoluminal Platform<br>* A DBA platform will be use din this registry study to facilitate ESD<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Submucosal Dissection