First in Man Aer-O-Scope

GI View

Status and phase: Terminated; Phase 1

Conditions: Screening Colonoscopy for Low Risk Subjects

Treatments: Biological: screening colonoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02102412

053 CLD ars 08

Details and patient eligibility

About

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

Full description

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)

Enrollment: 101 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

single arm

Experimental group

Description:

single arm patients underwent colonoscopy with aer-o-scope followed by conventional colonoscopy to assess if any mucosal damage occurred with the experimental device.

Treatment:

Biological: screening colonoscopy