Video Capsule Endoscopy (VCE) Comparison Study

NCT01090843 | Completed

• 1 other identifier: EK 961/2009
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bleeding; Anemia; Diarrhea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total video length

  The primary endpoint will be the total video length registered as well as the rate of successful ileocoecal transitions during ongoing video registration.

  6 months

Secondary Outcomes (1)

• Diagnostic yield

  6 months

Interventions

Video capsule endoscopy (VCE) PROCEDURE

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.

MiroCam DEVICE

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.

Enteropro EndoCapsule DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients transferred to our unit to undergo video capsule endoscopy because of
• Obscure digestive bleeding (ODB)
• Chronic anaemia of unknown origin
• Chronic diarrhoea

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Medicine III., Clinical Division of Gastroenterology and Hepatology

Vienna, A-1090, Austria

Location

Related Publications (9)

• Munoz-Navas M. Capsule endoscopy. World J Gastroenterol. 2009 Apr 7;15(13):1584-6. doi: 10.3748/wjg.15.1584.

  PMID: 19340899 BACKGROUND

• Nakamura T, Terano A. Capsule endoscopy: past, present, and future. J Gastroenterol. 2008;43(2):93-9. doi: 10.1007/s00535-007-2153-6. Epub 2008 Feb 29.

  PMID: 18306982 BACKGROUND

• 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. doi: 10.1080/00365520701251601.

  PMID: 17710680 BACKGROUND

• Westerhof J, Weersma RK, Koornstra JJ. Risk factors for incomplete small-bowel capsule endoscopy. Gastrointest Endosc. 2009 Jan;69(1):74-80. doi: 10.1016/j.gie.2008.04.034. Epub 2008 Aug 8.

  PMID: 18691709 BACKGROUND

• 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. doi: 10.1016/j.gie.2009.02.018. No abstract available.

  PMID: 19788996 BACKGROUND

• He Man Kim. Sequential capsule endoscopy of two different capsule endoscopes, MiroCam and Pillcam SB1, without interference: a pilot study. UEGW Oct 21, 2008.

  BACKGROUND

• Bang S, Park JY, Jeong S, Kim YH, Shim HB, Kim TS, Lee DH, Song SY. First clinical trial of the "MiRo" capsule endoscope by using a novel transmission technology: electric-field propagation. Gastrointest Endosc. 2009 Feb;69(2):253-9. doi: 10.1016/j.gie.2008.04.033. Epub 2008 Jul 21.

  PMID: 18640676 BACKGROUND

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

  PMID: 17925927 BACKGROUND

• 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. doi: 10.1016/j.gie.2007.12.037. Epub 2008 Apr 14.

  PMID: 18410941 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Anemia; Diarrhea

Interventions

Videotape Recording; Endoscopy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Andreas Puespoek, MD

  Medical University of Vienna

  STUDY DIRECTOR

• Werner Dolak, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 23, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 5, 2011

Record last verified: 2011-10

Locations

AU (1)