Video Capsule Endoscopy (VCE) Comparison Study - Full Text View

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:

MedlinePlus related topics: Anemia Diarrhea Endoscopy

U.S. FDA Resources

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:

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.

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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

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:

Muñoz-Navas M. Capsule endoscopy. World J Gastroenterol. 2009 Apr 7;15(13):1584-6.

Nakamura T, Terano A. Capsule endoscopy: past, present, and future. J Gastroenterol. 2008;43(2):93-9. Epub 2008 Feb 29. Review.

Kalantzis C, Triantafyllou K, Papadopoulos AA, Alexandrakis G, Rokkas T, Kalantzis N, Ladas SD. Effect of three bowel preparations on video-capsule endoscopy gastric and small-bowel transit time and completeness of the examination. Scand J Gastroenterol. 2007 Sep;42(9):1120-6.

Westerhof J, Weersma RK, Koornstra JJ. Risk factors for incomplete small-bowel capsule endoscopy. Gastrointest Endosc. 2009 Jan;69(1):74-80. Epub 2008 Aug 8.

Sanchez-Yague A. Risk factors for incomplete small-bowel capsule endoscopy: should capsule retention be considered independently? Gastrointest Endosc. 2009 Oct;70(4):820; author reply 820. No abstract available.

Gheorghe C, Iacob R, Bancila I. Olympus capsule endoscopy for small bowel examination. J Gastrointestin Liver Dis. 2007 Sep;16(3):309-13. Review.

Cave DR, Fleischer DE, Leighton JA, Faigel DO, Heigh RI, Sharma VK, Gostout CJ, Rajan E, Mergener K, Foley A, Lee M, Bhattacharya K. A multicenter randomized comparison of the Endocapsule and the Pillcam SB. Gastrointest Endosc. 2008 Sep;68(3):487-94. Epub 2008 Apr 14.

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 June 13, 2013