Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm
NCT ID: NCT04551014
Last Updated: 2022-09-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
158 participants
INTERVENTIONAL
2020-09-16
2021-07-15
Brief Summary
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Detailed Description
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1. Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon
2. Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon
3. Methods:
1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
2. If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift.
3. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
4. The polyp as well as well as the two biopsies are reviewed by a pathologist.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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With EverLift
Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.
Use of EverLift
Use of EverLift for submucosal injection prior to polypectomy
Without EverLift
Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
Without use of EverLift
Without use of EverLift for submucosal injection prior to polypectomy
Interventions
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Use of EverLift
Use of EverLift for submucosal injection prior to polypectomy
Without use of EverLift
Without use of EverLift for submucosal injection prior to polypectomy
Eligibility Criteria
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Inclusion Criteria
* Polyps 4-9mm
Exclusion Criteria
* Inflammatory bowel disease
* Polyposis syndromes
18 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Shai Friedland
Professor in Gastroenterology & Hepatology
Principal Investigators
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Shai Friedland, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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15766-2
Identifier Type: -
Identifier Source: org_study_id
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