First in Man Aer-O-Scope

Phase 1TerminatedNCT02102412

GI View Ltd.101 enrolled

Overview

A single center study intended to evaluate the Aer-O-Scope Colonoscope System.

A clinical study in Zagreb Croatia, intended to evaluate the Aer-O-Scope Colonoscope System. The study includes 120 subjects and has the following endpoints: Evaluation of the Aer-O-Scope advancement, imaging and retraction throughout the Colon. Safety: No occurrence of any device related major adverse event (for details see section 9.5) Efficacy: 1. Advancement of device towards the ceacum and retraction 2. Visualization of the colon mucosa by the traveling imaging device 3. Procedure duration 4. Handling and operation (assessment by operator)

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

101

Conditions

Screening Colonoscopy for Low Risk Subjects

Interventions

screening colonoscopyBIOLOGICAL

performance of a colonoscopy with the experimental device followed by complete conventional colonoscopy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers between 18 and 65 years of age. * Sign informed consent. Exclusion Criteria: * Subjects with any known GI related symptoms complaints or GI diseases. * Subjects with cancer or other life threatening diseases or conditions. * Pregnant women. * Subjects who underwent any abdominal surgery. * Morbid Obesity (BMI \> 40). * Drug abuse or alcoholism. * Bed-ridden subject. * Inadequate communication with the subject. * Subjects under custodial care. * Participation in any clinical study within the last 30 days. * Subjects with known cardiovascular and pulmonary diseases.

Locations (1)

Rebro Hospital

Zagreb, Croatia

Outcomes

Primary Outcomes

Ability to traverse the colon using the aer-o-scope

a propulsion system using low pressure co2 gas and balloons is used to propel the system through the colon

Time frame: under 60 minutes

Data from ClinicalTrials.gov

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