Video Capsule Endoscopy (VCE) Comparison Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Werner Dolak, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01090843
First received: March 22, 2010
Last updated: October 3, 2011
Last verified: October 2011
  Purpose

MiroCam® is the new video capsule endoscope of IntroMedic®. By using a novel transmission technology it promises a longer battery life expectancy with consequential impact on the length of the video recorded for diagnostic evaluation. As the investigators know about the shortcoming of battery life expectancy from many capsule examinations that were inconclusive because the ileocaecal transit was not filmed, the investigators would appreciate to have a capsule with extended video recording to improve the diagnostic yield of capsule examinations. Therefore the investigators want to compare MiroCam® to our routinely used Olympus® Enteropro EndoCapsule® in the context of a half-year clinical trial. Focussing on the total video length as well as on the rate of video-recorded ileocaecal transitions as surrogate parameters the investigators want to find out whether one of the two products provides superior diagnostic information in order to reduce the amount of inconclusive examinations.


Condition Intervention
Bleeding
Anemia
Diarrhea
Procedure: Video capsule endoscopy (VCE)
Device: MiroCam
Device: Enteropro EndoCapsule

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison Study of IntroMedic®'s MiroCam® and Olympus®' Enteropro EndoCapsule®

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Total video length [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary endpoint will be the total video length registered as well as the rate of successful ileocoecal transitions during ongoing video registration.


Secondary Outcome Measures:
  • Diagnostic yield [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The secondary end point will be the number of pathologies detected by each capsule.


Enrollment: 50
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Video capsule endoscopy (VCE)
    In the context of video capsule endoscopy the patient will swallow the first capsule after successful mounting of adhesive electrodes and registering tool of both capsule products. The second capsule will be swallowed two hours later. The two capsules used in our investigation are the MiroCam® (product of IntroMedic®, Seoul, Korea) and the Enteropro EndoCapsule® (product of Olympus®, Tokyo, Japan). To reduce bias made up by the sequence of the capsules used, we will randomize the capsule positions at each examination, following a computer generated list.
    Device: MiroCam
    In the context of video capsule endoscopy the patient will swallow the first capsule after successful mounting of adhesive electrodes and registering tool of both capsule products. The second capsule will be swallowed two hours later. The two capsules used in our investigation are the MiroCam® (product of IntroMedic®, Seoul, Korea) and the Enteropro EndoCapsule® (product of Olympus®, Tokyo, Japan). To reduce bias made up by the sequence of the capsules used, we will randomize the capsule positions at each examination, following a computer generated list.
    Device: Enteropro EndoCapsule
    In the context of video capsule endoscopy the patient will swallow the first capsule after successful mounting of adhesive electrodes and registering tool of both capsule products. The second capsule will be swallowed two hours later. The two capsules used in our investigation are the MiroCam® (product of IntroMedic®, Seoul, Korea) and the Enteropro EndoCapsule® (product of Olympus®, Tokyo, Japan). To reduce bias made up by the sequence of the capsules used, we will randomize the capsule positions at each examination, following a computer generated list.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients transferred to our unit to undergo video capsule endoscopy because of

  • Obscure digestive bleeding (ODB)
  • Chronic anaemia of unknown origin
  • Chronic diarrhoea

Exclusion Criteria:

  • Patients age below 18 years
  • Patients presenting with contraindications to video capsule endoscopy which are already known gastrointestinal stenoses, already known gastrointestinal adhesions, already known diverticula of the small bowel, already known severe or diabetes induced intestinal hypomotility
  • Refusal to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090843

Locations
Austria
Medical University of Vienna, Department of Medicine III., Clinical Division of Gastroenterology and Hepatology
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Director: Andreas Puespoek, MD Medical University of Vienna
Principal Investigator: Werner Dolak, MD Medical University of Vienna
  More Information

Publications:
Responsible Party: Werner Dolak, MD, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01090843     History of Changes
Other Study ID Numbers: EK 961/2009
Study First Received: March 22, 2010
Last Updated: October 3, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Obscure digestive bleeding (ODB)
Chronic anaemia of unknown origin
Chronic diarrhoea

Additional relevant MeSH terms:
Anemia
Diarrhea
Hemorrhage
Hematologic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014