First in Man Aer-O-Scope

NCT02102412 | Terminated Phase 1 DMC

• 1 other identifier: 053 CLD ars 08
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Screening Colonoscopy for Low Risk Subjects

Keywords

crc; colonoscopy; colon cancer

Outcome Measures

Primary Outcomes (1)

• 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

  under 60 minutes

Study Arms (1)

single arm

EXPERIMENTAL

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

Biological: screening colonoscopy

Interventions

screening colonoscopy BIOLOGICAL

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

Also known as: colonoscopy

single arm

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers between 18 and 65 years of age.
• Sign informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GI View Ltd.: lead

Study Sites (1)

Rebro Hospital

Zagreb, Croatia

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Colonoscopy

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

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Boris Vucelic, MD

  Chief Gastro, Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2014
• First Posted: April 2, 2014
• Study Start: February 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 1, 2017

Record last verified: 2014-03

Locations

CR (1)