Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Given Imaging Ltd. |
---|---|
Information provided by: | Given Imaging Ltd. |
ClinicalTrials.gov Identifier: | NCT00604162 |
PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.
Condition |
---|
Colonic Diseases |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Evaluation of PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon |
Enrollment: | 392 |
Study Start Date: | October 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
---|
1
Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.
|
The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. Further details of the PillCam™ Colon Capsule Endoscope (PCCE) can be found in the device description section.
This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
suspected and known colonic disease patients
Inclusion Criteria:
Subject was referred for colonoscopy for one of the following reasons:
Any subject ≥ 18 years of age with:
Exclusion Criteria:
France | |
CHU Lyon | |
Lyon, France | |
CHU Nancy | |
Nancy, France | |
Germany | |
Evangelisches Krankenhaus | |
Dusseldorf, Germany | |
AK Altona | |
Hamburg, Germany | |
Italy | |
Ospedale Gemelli | |
Rome, Italy | |
Spain | |
Clinica Universitaria de Navarra | |
Pamplona, Spain | |
United Kingdom | |
St.Marks&Northwick Park hospital | |
Harrow, United Kingdom |
Principal Investigator: | Jacques DEVIERE, M.D | Hôpital Erasme |
Responsible Party: | Given Imaging Ltd. ( Yael Koren ) |
Study ID Numbers: | MA-53 |
Study First Received: | January 24, 2008 |
Last Updated: | January 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00604162 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; United Kingdom: National Health Service; Germany: Federal Institute for Drugs and Medical Devices; Italy: National Institute of Health; Spain: Spanish Agency of Medicines |
Suspected colonic disease Known colonic disease |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |