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

Primary Purpose

Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyp of Colon

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of EverLift
Without use of EverLift
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colo-rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Inflammatory bowel disease
  • Polyposis syndromes

Sites / Locations

  • Veterans Affairs Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

With EverLift

Without EverLift

Arm Description

Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.

Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.

Outcomes

Primary Outcome Measures

Number of Polyps With Complete Resection
The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.

Secondary Outcome Measures

Time to Resection
The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups.
Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.
Number of Patients With Procedural Complications
Procedural complications include 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.

Full Information

First Posted
September 9, 2020
Last Updated
August 12, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04551014
Brief Title
Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm
Official Title
Randomized Controlled Trial Investigating Use of Submucosal Injection of EverLift in Rates of Complete Resection of Nonpedunculated Polyps 4-9mm
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The details of the proposed study are as follows: Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon Methods: Colonoscopy will be performed in the same standard of care manner as if no study was taking place. If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion. The polyp as well as well as the two biopsies are reviewed by a pathologist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyp of Colon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With EverLift
Arm Type
Experimental
Arm Description
Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.
Arm Title
Without EverLift
Arm Type
Experimental
Arm Description
Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
Intervention Type
Device
Intervention Name(s)
Use of EverLift
Intervention Description
Use of EverLift for submucosal injection prior to polypectomy
Intervention Type
Device
Intervention Name(s)
Without use of EverLift
Intervention Description
Without use of EverLift for submucosal injection prior to polypectomy
Primary Outcome Measure Information:
Title
Number of Polyps With Complete Resection
Description
The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Time to Resection
Description
The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups.
Time Frame
During the procedure
Title
Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.
Time Frame
During the procedure (up to 10 minutes)
Title
Number of Patients With Procedural Complications
Description
Procedural complications include 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.
Time Frame
4 weeks (from procedure through 30 day follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients 18 years or older Polyps 4-9mm Exclusion Criteria: Pregnant Inflammatory bowel disease Polyposis syndromes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai Friedland, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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