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Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule

Sponsor
Hôpital Edouard Herriot (Other)
Overall Status
Completed
CT.gov ID
NCT01820182
Collaborator
Capso Vision, Inc. (Industry)
73
Enrollment
1
Arm
17
Duration (Months)

Study Details

Study Description

Brief Summary

Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging, Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices are administered is randomly allocated.

Condition or Disease Intervention/Treatment Phase
  • Device: capsule endoscopies
 N/A

Detailed Description

Objectives

Main objective

To compare the diagnostic yield of both capsules in the same patients with a satisfying concordance coefficient k>0,6

Secondary objectives

To compare the sensitivity and specificity of both capsule readings To copmpare the sensitivity and specificity for specific lesions classified in terms of relevance P0 P1 P2 To check the tecnical fiability (incidence of technical issues To check the feasibility To evaluate the rate of complete small bowel examination, the small bowel transit time the capsule reading time

Study Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule in Patients With Obscure Digestive Bleedings
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: capsocam capsula

capsocam capsula readings

Device: capsule endoscopies
Patients inclusion following inclusion criterias Randomization of capsule ingestion order Videocapsule recording by the two capsules Reading of the two capsules films in randomized order by two different readers in each center Reviewing of discordant capsule films by an expert panel
Other Names:
  • Pillcam SB2
  • Capsocam

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of discordant films between the two capsules with two different readers [14 days]

      Reading of the two capsules film is randomized order by two different readers in each center

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • over 18 years old

    • obscure digestive bleeding justifying capsule endoscopy

    • complete endoscopic work up including colonoscopy with ileoscopy and gastroscopy with aneathesia or sedation

    • absence of concomittent ongoing study

    • absence of occlusive symptoms of suspected Crohn's disease nor of previous small bowel radiotherapy

    • filled inform consent

    • no implanted pace maker

    • patient being affiliated to the CPAM

    Exclusion Criteria:

    • under 18 years old

    • oral iron within 8 days before capsule endoscopy

    • gastroparesis

    • pacemaker

    • swallowing troubles

    • presence of oclusive symptoms suspected Crohn's disease nor of previous small bowel radiotherapy

    • pregnancy or risk of pregnancy without efficient oral contraception

    • absence of written informed consent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hôpital Edouard Herriot
    • Capso Vision, Inc.

    Investigators

    • Principal Investigator: Saurin JS Jean Christophe, Msd,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jean Christophe Saurin, Proffessor, Hôpital Edouard Herriot
    ClinicalTrials.gov Identifier:
    NCT01820182
    Other Study ID Numbers:
    • 2010-023341-29
    First Posted:
    Mar 28, 2013
    Last Update Posted:
    Aug 9, 2018
    Last Verified:
    Oct 1, 2010
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Gastrointestinal Hemorrhage
    Angiodysplasia
    Hemorrhage

    Study Results

    No Results Posted as of Aug 9, 2018