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| Sponsor: | Nantes University Hospital |
|---|---|
| Information provided by: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00561938 |
Purpose
Confocal laser endomicroscopy (CLE) is a new diagnostic technique that allows microscopic examination of the digestive mucosa during ongoing endoscopy. Different types of tissue and diseases can be diagnosed immediately, and analysis of the in vivo microarchitecture is helpful to better target standard biopsies and reduce the number of biopsies required. CLE necessitates an intravenous injection of a fluorescent marker, e.g. fluorescein, to obtain 'optical biopsies' with a high level of magnification (up to 1000 fold). To date, more than 1000 endomicroscopy procedures have been performed in the world and different publications have shown the safety, feasibility and excellent diagnostic yield of CLE. No complication related to IV injection of fluorescein has been reported. However, all these data come from a very limited number of expert centres and need to be confirmed and validated at the multicenter level. The aims of this multicenter trial are: 1) to standardize CLE in all centres equipped in France, 2) to ensure the safety of intravenous fluorescein injection, 3) to test the diagnostic value of CLE in various conditions representative of the large spectrum of different cancerous and non-cancerous digestive diseases.
| Condition | Intervention |
|---|---|
|
Digestive System Diseases |
Procedure: Colonoscopy Procedure: Endoscopy |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Confocal Laser Endomicroscopy in the Digestive Tract: A Multicentre French Pilot Study. |
| Enrollment: | 61 |
| Study Start Date: | June 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| France | |
| Service d'Hépato-Gastroentérologie, CHU Nantes | |
| Nantes, France, 44093 | |
| Service d'Hépato-Gastroentérologie, Institut Paoli Calmettes | |
| Marseille, France, 13009 | |
| Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon Sud | |
| Lyon, France, 69495 | |
| Service d' hépato-gastro-entérologie, CHU de ROUEN | |
| Rouen, France, 76031 | |
| CHU de Rangueil | |
| Toulouse, France, 31059 | |
| Principal Investigator: | Jean-Paul Galmiche, PhD | Centre Hospitalier Universitaire de Nantes |
More Information
| Study ID Numbers: | BRD 07/3-Q |
| Study First Received: | November 20, 2007 |
| Last Updated: | February 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00561938 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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Confocal laser endomicroscopy cancerous and non-cancerous conditions tolerance intravenous fluorescein Digestive symptoms or disease requiring an endoscopy procedure (upper GI endoscopy or colonoscopy) performed under general anaesthesia |
|
Digestive System Diseases |