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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by GI View Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
GI View Ltd.
ClinicalTrials.gov Identifier:
NCT00867724
First received: March 23, 2009
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Colon Cancer
Rectal Cancer
Device: aeroscopy (aer-o-scope)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Clinical Study to Evaluate the Performance & Safety of the "Aer-O-Scope" Traveling Through the Colon in Low Risk Subjects

Resource links provided by NLM:


Further study details as provided by GI View Ltd.:

Primary Outcome Measures:
  • Ability to screen the entire length of the colon to the cecum. [ Time Frame: 30 -60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aeroscopy/Colonoscopy
Observational study - training cohort and study cohort.
Device: aeroscopy (aer-o-scope)
screening of the colon for crc using the aer-o-scope

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867724

Locations
Israel
Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Erwin Santo, MD    972-3-697-4969    erwin@tasmc.health.gov.il   
Principal Investigator: Ervin Santo, MD         
Sponsors and Collaborators
GI View Ltd.
Investigators
Principal Investigator: Erwin M Santo, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Dr. Erwin Santo, Souraski Medical Center
ClinicalTrials.gov Identifier: NCT00867724     History of Changes
Other Study ID Numbers: 190-CLD-AOS
Study First Received: March 23, 2009
Last Updated: June 9, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by GI View Ltd.:
polyp

ClinicalTrials.gov processed this record on October 19, 2014