Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients

NCT00867724 | Completed

• 1 other identifier: 190-CLD-AOS
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.

Conditions

Colon Cancer; Rectal Cancer

Keywords

polyp

Outcome Measures

Primary Outcomes (1)

• Ability to screen the entire length of the colon to the cecum.

  30 -60 minutes

Secondary Outcomes (1)

• Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events

  24 hours

Study Arms (1)

Aer-O-Scope Colonoscopy

EXPERIMENTAL

Screening Colonoscopy

Device: Aer-O-Scope Colonoscopy

Interventions

Aer-O-Scope Colonoscopy DEVICE

Screening Colonoscopy

Also known as: Aer-O-Scope

Aer-O-Scope Colonoscopy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients between 18 and 70 years of age
• Patients who are generally healthy and classified as low risk for CRC
• Patients who are ready to undergo standard colonoscopy examination including colon prep.
• Signed informed consent

You may not qualify if:

• Patients with any known GI related symptoms complaints or GI diseases
• Patients with cancer or other life threatening diseases or conditions
• Patients with unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal' gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety. Patients with a known history of blood clotting problems and /or who are on anti-coagulant therapy and cannot stop treatment for the purpose of this study. (Patients taking up to 100mg aspirin for prophylactic treatment are acceptable for this study).
• Pregnant women
• Patients who underwent abdominal surgery that is deemed by the investigator to effect the procedure
• Morbid Obesity (BMI \> 40)
• Drug abuse or alcoholism
• Bed-ridden patient
• Inadequate communication with the patient
• Patients under custodial care
• Participation in current clinical study or clinical study within 30 days prior to the procedure

Sponsors & Collaborators

• GI View Ltd.: lead

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Polyps

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; Rectal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Erwin M Santo, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)