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

September 5, 2023 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: CAILLON Cynthia
  • Phone Number: +0033 4 92 03 45 89
  • Email: drc@chu-nice.fr

Study Locations

  • France
      • Nice, France, 06000
        • Digestive department - Archet hospital
  • Italy
      • San Remo, Italy
        • Gastro entérology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)
Device: Comparison of capsule endoscopy Pillcam II™ versus colonoscopy
On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 7 days
The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores on the Visual Analog Scale
Time Frame: 7 days

Presence of at least one polyp at capsule endoscopy and colonoscopy with both operators unaware of each other's findings until completion of the procedures.

Comparison of the different class of size for all polyps Comparison of Kudo and Paris classification of the polyps at endoscopy capsule and colonoscopy Tolerance, pain and discomfort between the both procedure Acceptability of both procedure at day 1 and day 7 Accuracy of the localization of the polyp or the lesion at the capsule endosocpy comparated with the colonoscopy topography (Gold standard).
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Study Director: HEBUTERNE Xavier, PU-PH, Digestive department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 26, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (Estimated)

August 19, 2010

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-PP-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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