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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.
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 DiLumenâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic procedure | A double balloon endoscopic platform will be used during an ESD procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Balloon Endoluminal Platform | Device | A DBA platform will be use din this registry study to facilitate ESD |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with documented complex large intestinal polyps
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| Name | Affiliation | Role |
|---|---|---|
| Stavros Stavropoulos, MD | Winthrop-NYU Langone Mineola, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop-NYU Langone | Mineola | New York | 11501 | United States |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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