Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients
This study is currently recruiting participants.
Verified June 2011 by GI View Ltd.
Sponsor:
GI View Ltd.
Information provided by:
GI View Ltd.
ClinicalTrials.gov Identifier:
NCT00867724
First received: March 23, 2009
Last updated: June 9, 2011
Last verified: June 2011
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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
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 |
Additional relevant MeSH terms:
|
Colonic Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013