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

NCT04551014 | Completed Results FDA Device

• 1 other identifier: 15766-2
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to Resection

  During the procedure

• Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.

  During the procedure (up to 10 minutes)

• Number of Patients With Procedural Complications

  4 weeks (from procedure through 30 day follow-up)

Study Arms (2)

With EverLift

EXPERIMENTAL

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

Device: Use of EverLift

Without EverLift

EXPERIMENTAL

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

Device: Without use of EverLift

Interventions

Use of EverLift DEVICE

Use of EverLift for submucosal injection prior to polypectomy

With EverLift

Without use of EverLift DEVICE

Without use of EverLift for submucosal injection prior to polypectomy

Without EverLift

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant
• Inflammatory bowel disease
• Polyposis syndromes

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Shai Friedland, MD
• Organization: Stanford University

shaif@stanford.edu

650-723-4000

Study Officials

• Shai Friedland, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Gastroenterology & Hepatology

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: September 16, 2020
• Primary Completion: May 31, 2021
• Study Completion: July 15, 2021
• Last Updated: September 1, 2022
• Results First Posted: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)