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

Rectal Cancer Clinical Trial

Official title:

A Clinical Study to Evaluate the Performance & Safety of the "Aer-O-Scope" Traveling Through the Colon in Low Risk Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867724
• Other study ID #: 190-CLD-AOS
• Status: Completed
• Phase: N/A
• First received: March 23, 2009
• Last updated: July 30, 2017
• Start date: September 2009
• Est. completion date: July 2013

Study information

• Verified date: July 2017
• Source: GI View Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Asymptomatic adults between the ages of 18 and 70 will undergo screening of the colon using the aer-o-scope, under fluoroscopy, following by screening of the colon using a standard approved colonoscopy for determination of safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colon Cancer
• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• Aer-O-Scope Colonoscopy
Screening Colonoscopy

Locations

Country	Name	City	State
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
GI View Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to screen the entire length of the colon to the cecum.		30 -60 minutes
Secondary	Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events		24 hours