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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04551014
• Collaborator: (none)
• Enrollment: 159
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.9
• Patients Per Site Per Month: 16

Study Details

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.

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	N/A

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:

4. Colonoscopy will be performed in the same standard of care manner as if no study was taking place.

5. If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift.

6. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.

7. The polyp as well as well as the two biopsies are reviewed by a pathologist.

Study Design

• Study Type: Interventional
• 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: Sep 16, 2020
• Actual Primary Completion Date: Jul 15, 2021
• Actual Study Completion Date: Jul 15, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Completeness of resection [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 [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 [During the procedure]

3. Complications [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients 18 years or older

• Polyps 4-9mm

Exclusion Criteria:

• Pregnant

• Inflammatory bowel disease

• Polyposis syndromes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Palo Alto Health Care System	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Shai Friedland, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shai Friedland, Professor in Gastroenterology & Hepatology, Stanford University
• ClinicalTrials.gov Identifier: NCT04551014
• Other Study ID Numbers: 15766-2
• First Posted: Sep 16, 2020
• Last Update Posted: Sep 14, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Adenomatous Polyps; Polyps; Colonic Polyps

Study Results

No Results Posted as of Sep 14, 2021