Project PREVAM : Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-11-30

Brief Summary

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The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and a high resolution colonoscope (with high definition). Both procedures will be perform in the same day with an adapted bowel preparation.

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Detailed Description

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Conditions

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Adenomatous Polyps Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)

Group Type OTHER

Comparison of capsule endoscopy Pillcam II™ versus colonoscopy

Intervention Type DEVICE

On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)

Interventions

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Comparison of capsule endoscopy Pillcam II™ versus colonoscopy

On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No