Advertisement

Topics

Video Capsule Endoscopy (VCE) Comparison Study

2014-08-27 03:15:04 | BioPortfolio

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.

Description

Introduction

Video capsule endoscopy (VCE) is an important tool in the diagnostic management of several gastrointestinal (GI) disorders. Taking a video while passing the GI tract, VCE is the only technique providing image information of the whole small bowel. It is a comfortable and safe procedure; complications due to capsule retention are rare [1]. The main disadvantage of VCE is made up by its only dependence on macroscopic information. Therefore it can not be reliably used for the detection of disorders that need histological confirmation. However, lots of macroscopic pathologies can be diagnosed or excluded by VCE. Above all, obscure digestive bleeding (ODB) has become the main indication for the use of VCE [2].

Independent from the type of bowel preparation used, the ileocaecal transit cannot be visualized in up to 20 percent of VCE examinations, which means the loss of diagnostic information of the last intestinal parts [3]. Risk factors of such incomplete VCE include previous small-bowel surgery, hospitalization, moderate or poor bowel cleansing and a gastric transit time longer than 45 minutes [4]. Especially in the latter case, the success of the examination is determined by the battery life expectancy of the capsule technology used [5].

The new MiroCam®, a brand of IntroMedic®, is advertised to have a longer battery life expectancy than competitive products throughout the market. To prove this pronouncement, a pilot-study of 16 patients was presented by He Man Kim at the UEGW 2008, comparing MiroCam® to Given®'s PillCam® by sequential application of both capsules. Although the battery life expectancy of MiroCam® was significantly higher, there was no significant difference in the diagnostic yield of both products [6]. Currently a similar comparison study between MiroCam® and Pill Cam® is ongoing in France, involving a higher amount of patients [unpublished data].

Study Aims

In this prospective study we want to compare IntroMedic®'s MiroCam® to Olympus® Enteropro EndoCapsule® which was so far routinely used at our department. We want to investigate whether one of the two products provides superior diagnostic information about the small bowel. The primary endpoint will be the total video length registered as well as the rate of successful ileocoecal transitions during ongoing video registration. The secondary end point will be the number of pathologies detected by each capsule. If there will be a significant difference between the two tested products, preferred usage of the superior product may improve the diagnostic yield of future examinations by avoiding incomplete video registration of the small bowel.

Study Design

Prospective Study without randomisation or blinding

Study Population

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

Methods

Our investigation will be performed at the Medical University of Vienna, department of medicine III, clinical division of gastroenterology and hepatology. Patient recruitment will start on the 1st of January 2010. The study will last for six month. The number of patients included within this period will be around 50, based on the current amount of VCE examinations performed at our department.

All patients who fulfil the listed inclusion criteria, will receive the patient information form of this study together with the routine informed consent form of VCE. Potentially occurring questions about the course of the examination, data acquisition and processing in context of the study will be answered by medical professionals.

As routine preparation for VCE, patients will receive 2 litres of washout solution on the previous day of their examination. At the day of the procedure fasting is required. 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 - to our knowledge the first capsule will have already passed the gastro-duodenal transit at this time. The two capsules used in our investigation are the already mentioned 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. After both capsules have been swallowed, fasting has to be continued for four hours to prevent image interference of VCE.

Risk/Benefit Assessment

The safety of both products used within our investigation was already proved in former clinical trials [7, 8]. For the patients enrolled in our study the potentially higher risk of complications will be made up for the expected increase of diagnostic yield that will be implicated by the evaluation of two different bowel videos. The only notable discomfort for patients participating in our investigation will be caused by the rather high amount of adhesive electrodes necessary for both capsules. There should not be any interference of the two video signals as already shown in former investigations [6,9].

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Conditions

Bleeding

Intervention

Video capsule endoscopy (VCE), MiroCam, Enteropro EndoCapsule

Location

Medical University of Vienna, Department of Medicine III., Clinical Division of Gastroenterology and Hepatology
Vienna
Austria
A-1090

Status

Recruiting

Source

Medical University of Vienna

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:04-0400

Clinical Trials [1417 Associated Clinical Trials listed on BioPortfolio]

Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study

Wireless video capsule endoscopy (VCE) is a non-invasive technology that looks into small intestine and gives images of its lumen as the wireless capsule passes through it. It is used wide...

Capsule Endoscopy in Obscure GI Bleeding

The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform...

Capsule Endoscopy for HEmorrhage in the ER

This is a multi-center randomized controlled trial examining the use of Video Capsule Endoscopy (VCE) to discharge low-moderate risk patients with suspected upper gastrointestinal bleeds (...

An Economic Evaluation of Capsule Endoscopy for Obscure-Occult Gastrointestinal (GI) Bleeding

The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with obscure-occult gastrointestinal bleeding. To perfo...

An Observer Blinded Comparison of MACE and Conventional Upper Gastrointestinal Endoscopy in Upper GI Bleeding

Gastroscopy (OGD) is a useful test for investigating a variety of suspected upper GI disorders. But it is uncomfortable for patients and incurs the risk of intubation and sedation, plus a ...

PubMed Articles [2729 Associated PubMed Articles listed on BioPortfolio]

Long-term follow up of patients with obscure gastrointestinal bleeding examined with video capsule endoscopy.

Video capsule endoscopy (VCE) is a commonly used test for the evaluation of obscure gastrointestinal bleeding. However, long-term outcomes of patients undergoing VCE are unclear.

Meckel's diverticulum on third-generation video capsule endoscopy: intradiverticular ulcer, ectopic gastric mucosa, and active bleeding.

A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to non-hematemesis gastrointestinal bleeding (with videos).

Patients presenting with non-hematemesis GI bleeding represent a diagnostic challenge for physicians. We performed a randomized controlled trial to assess the benefits of deployment of a video capsule...

Detection of infection mimicking Crohn's disease using video capsule endoscopy.

Capsule endoscopy was used to detect intestinal infection in a 19-year-old man. The patient was initially believed to have Crohn's disease due to a notable family history of the disease. Capsule endo...

Clear Liquids versus Polyethylene Glycol Preparation for Video Capsule Endoscopy of the Small Bowel: A Randomized Controlled Trial.

An effective bowel cleanse can improve the imaging quality of video capsule endoscopy (VCE). We aimed to further investigate the optimal small bowel cleanse method by comparing the efficacy of 4 L of ...

Medical and Biotech [MESH] Definitions

Non-invasive, endoscopic imaging by use of VIDEO CAPSULE ENDOSCOPES to perform examination of the gastrointestinal tract, especially the small bowel.

Procedures of applying ENDOSCOPES for disease diagnosis and treatment. Endoscopy involves passing an optical instrument along either natural body pathways such as the digestive tract, or through keyhole incisions to examine the interior parts of the body. With advances in imaging, endoscope, and miniaturization of endosurgical equipment, surgery can be performed during endoscopy.

Used with articles which include video files or clips, or for articles which are entirely video.

Endoscopic surgical procedures performed with visualization via video transmission. When real-time video is combined interactively with prior CT scans or MRI images, this is called image-guided surgery (see SURGERY, COMPUTER-ASSISTED).

A form of interactive entertainment in which the player controls electronically generated images that appear on a video display screen. This includes video games played in the home on special machines or home computers, and those played in arcades. (McGraw Hill Encyclopedia of Science & Technology, 7th ed, v19, p223)

More From BioPortfolio on "Video Capsule Endoscopy (VCE) Comparison Study"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Clostridium difficile (CDI)
A clostridium difficile infection (CDI) is a type of bacterial infection that can affect the digestive system. It most commonly affects people who are staying in hospital.  The symptoms of CDI can range from mild to severe and include: diarrhoe...


Searches Linking to this Trial