An observational study in Colon Adenoma and Colon Polyp, sponsored by Lumendi, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Lumendi, LLC · Observational
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 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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 15 is below the median of 300 across 226 observational studies indexed under Adenoma.
Browse Adenoma studies →Lumendi, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with documented complex large intestinal polyps
Exclusion Criteria:
A double balloon endoscopic platform will be used during an ESD procedure
Device: Double Balloon Endoluminal Platform
A DBA platform will be use din this registry study to facilitate ESD
Ability to remove the complex polyp endoscopically
Was the lesion(s) able to be removed using the DiLumen Endolumenal Interventional Platform Device \[Yes/No\]
Time frame: Duration of Procedure
Time taken for lesion removal
Time for lesion(s) removal with the double balloon device after intervention begins
Time frame: Intervention start time until Lesion removal
Device or Procedural Adverse Events
Colon perforation, colon mucosal injury, excess bleeding will be recorded
Time frame: Up to 72 hours
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Lumendi, LLC