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Completed

NCT Number: NCT04551014

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

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.

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Key information

Conditions

Colo-rectal Cancer Adenomatous Polyp of Colon Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyp of Colon Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Affairs Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant
  • Inflammatory bowel disease
  • Polyposis syndromes

Treatment and study plan

Use of EverLift

Device

Use of EverLift for submucosal injection prior to polypectomy

Without use of EverLift

Device

Without use of EverLift for submucosal injection prior to polypectomy

Primary outcomes

  1. Number of Polyps With Complete Resection

    Time frame: 2 weeks

    The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.

Secondary outcomes

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

    Time frame: During the procedure (up to 10 minutes)

  3. Number of Patients With Procedural Complications

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

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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