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Post Market Evaluation of Aer-O-Scope Visualization

NCT02926209 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2019-07-16

Study results available
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Summary

This will be a prospective multi-center, multi-national comparative non-blinded clinical investigation. Each subject will undergo back-to-back tandem colonoscopies with the Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem colonoscopy study, each subject will serve as their own control. The 1st procedure will be randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The same investigator will perform both procedures on each subject. All pathologies found will be either removed or tattooed. Unmarked pathologies found on second pass will represent those missed during the 1st pass, thus making the subject and the control one and the same. Tattooed pathologies that can be removed endoscopically will be removed in an additional colonoscopy. This may occur if a large polyp cannot be removed for any reason with the Aer-O-Scope, but can be removed with conventional colonoscopy.

Conditions

Interventions

DEVICE

Aer-O-Scope (Colonoscopy)

Patients in the "Aer-O-Scope first arm" will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope.

PROCEDURE

Colonoscopy (Conventional Colonoscope)

Patients in the "conventional colonoscope first arm" will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope

Sponsors & Collaborators

  • GI View Ltd.

    lead INDUSTRY

Principal Investigators

  • Erwin Santo, MD · Tel Aviv Souraski Medical Center, Israel

  • Klaus Mergener, MD, PhD, MBA · Waldron Endoscopy Center, Tacoma, WA, USA

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2017-11-08
Completion
2018-04-11
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02926209 on ClinicalTrials.gov