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Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-Individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Status
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Age
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Protocol IDs
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No phase specified
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Screening
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Active
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18 to 80
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Other
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BRD 06/12-L NCT00436514
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Trial Description
Summary Colorectal cancer is one of the most frequent and it pronosis is still serious. In France, diagnosis and screening applicated in numerous deprtements, and now in a path of generalization to the all country, is based on combination of searching blood into bowel movements (Hemocult) for the screening of population with medium risk (age between 50 to 74 years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the patients with a high risk.Even if the efficiency of this strategy is proved, searching blood into the bowel movement by Hemocult is still imperfect (a lot of false negative). Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and it constitu an invasiv method, with complications, with a compulsory general anesthesia, implicating a high cost. The alternative of a screening method based on a non invasiv method is required. Eligibility Criteria Inclusion Criteria: - age between 18 and 80 years
- patient able to give his informed consent
- No colorectal, intestinal inflammatory, ischemic or evolving infectious pathologies
- No signs of stenosis of small intestine or colon
- No contraindication to anesthesia
- No particpation to an other clinical study
- Patient with and indication to colonoscopy for searching of a colorectal neoplasia during a screening program OR
- Patient for who a endoscopic following is required because of familial cases or personnal cases of polypes or colorectal cancer
Exclusion Criteria: - Presence of symptoms evocating an occlusiv pathology
- Recent complicated colic diverticulosis
- pregnancy or no use of efficient contraception treatment
- Patient with a pace-maker or others internal medical electronic device
- Evoluted nephric or cardic insufficiences
- Hypersensibility to Fleet Phospho Soda (or one of the excipient), bisacodyl (or one of the excipient), motilium (or one of the excipient)
- Presence of a prolactinome
Trial Contact Information
Trial Lead Organizations/Sponsors CHR Hotel Dieu Jean Paul Galmiche, MD | | Study Director |
Stanislas Chaussade, MD | | Principal Investigator |
Marie-Georges Lapalus, MD | | Principal Investigator |
Christophe Cellier, MD | | Principal Investigator |
Denis Heresbach, MD | | Principal Investigator |
Bernard Filoche, MD | | Principal Investigator |
Vincent Maunoury, MD | | Principal Investigator |
Gerard Gay, MD | | Principal Investigator |
Thierry Barrioz, MD | | Principal Investigator |
Emmanuel Ben Soussan, MD | | Principal Investigator |
Dimitri Coumaros, MD | | Principal Investigator |
Trial Sites
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00436514 Information obtained from ClinicalTrials.gov on May 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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