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Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population


N/A
18 Years
N/A
Open (Enrolling)
Both
Adenomatous Polyps, Cancer

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Trial Information

Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population


Inclusion Criteria:



- Age > 18 years old

- Patient with 40 years old and first degree relative affected by colo rectal cancer at
age ≥ 60 ans

- Patient with 40 years old or ten years before the age at affected disease in case or
first deree relative colo rectal cancer before 60 years old.

- Fecal occult blood test positive

- Personal history of adenomatous polyps

- Personnal history of acromegaly

- Patient with social insurance

- Persons already participating in another clinical trial..

- Signature of informed consent

Exclusion Criteria:

- Pregnancy or breast feeding woman

- Déficience mentale du sujet rendant sa participation à l'essai impossible

- Pacemaker or all electronic devices implanted

- Patient with swallowing disorder, or digestive stricture know or suspected by the
investigator

- Previous history of intestinal surgery, radiotherapy or inflammatory bowel disease

- Previous history of polyadenomatous congenital disease, Lynch syndrome

- Intolerance with dompéridon and/or bisacodyl

- Intolerance with oral intake of NaP, polyethylen glycol (PEG) or macrogol

- Colonoscopy contre indication for anesthesiologic reasons

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer.

Outcome Time Frame:

7 days

Safety Issue:

No

Principal Investigator

HEBUTERNE Xavier, PU-PH

Investigator Role:

Study Director

Investigator Affiliation:

Digestive department

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

10-PP-02

NCT ID:

NCT01184781

Start Date:

August 2010

Completion Date:

November 2013

Related Keywords:

  • Adenomatous Polyps
  • Cancer
  • Polyps
  • Adenomatous Polyps

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