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

Colo-rectal Cancer Clinical Trial

Official title:

Randomized Controlled Trial Investigating Use of Submucosal Injection of EverLift in Rates of Complete Resection of Nonpedunculated Polyps 4-9mm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551014
• Other study ID #: 15766-2
• Status: Completed
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: August 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: July 15, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years or older

• Polyps 4-9mm

Exclusion Criteria:

• Pregnant

• Inflammatory bowel disease

• Polyposis syndromes

Related Conditions & MeSH terms

• Adenomatous Polyp of Colon
• Adenomatous Polyps
• Colo-rectal Cancer
• Colonic Polyps
• Polyp of Colon
• Polyps

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Veterans Affairs Palo Alto Health Care System	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Polyps With Complete Resection	The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.	2 weeks
Secondary	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.	During the procedure
Secondary	Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.		During the procedure (up to 10 minutes)
Secondary	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.	4 weeks (from procedure through 30 day follow-up)