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Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm

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ClinicalTrials.gov Identifier: NCT04551014
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Shai Friedland, Stanford University

Study Description
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Brief Summary:
The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.

Condition or disease Intervention/treatment Phase
Colo-rectal Cancer Polyp of Colon Adenomatous Polyp of Colon Device: Use of EverLift Device: Without use of EverLift Not Applicable

Detailed Description:

The details of the proposed study are as follows:

  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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Investigating Use of Submucosal Injection of EverLift in Rates of Complete Resection of Nonpedunculated Polyps 4-9mm
Actual Study Start Date : September 16, 2020
Actual Primary Completion Date : July 15, 2021
Actual Study Completion Date : July 15, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: With EverLift
Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.
 Device: Use of EverLift
Use of EverLift for submucosal injection prior to polypectomy
Experimental: Without EverLift
Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
 Device: Without use of EverLift
Without use of EverLift for submucosal injection prior to polypectomy


Outcome Measures
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Primary Outcome Measures :
  1. Completeness of resection [ Time Frame: 2 weeks ]
    The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.


Secondary Outcome Measures :
  1. Time to resection [ Time Frame: During the procedure ]
    The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups.

  2. We will compare the number of snare attempts needed to remove the tissue adequately to the endoscopist's judgment [ Time Frame: During the procedure ]
  3. Complications [ Time Frame: 4 weeks ]
    We will compare rates of complications including perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients 18 years or older
  • Polyps 4-9mm

Exclusion Criteria:

  • Pregnant
  • Inflammatory bowel disease
  • Polyposis syndromes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551014


Locations
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United States, California
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Shai Friedland, MD Stanford University
More Information
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Responsible Party: Shai Friedland, Professor in Gastroenterology & Hepatology, Stanford University
ClinicalTrials.gov Identifier: NCT04551014    
Other Study ID Numbers: 15766-2
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Adenomatous Polyps
Polyps
Colonic Polyps
Neoplasms
Pathological Conditions, Anatomical
 Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Polyps