Clinical Trial on Ulcerative Colitis, Colonic Disease - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Detailed Description

Ulcerative colitis (UC) is a disorder of unknown origin that may be characterized by acute and chronic inflammation of the colon. The extent of the colonic mucosal inflammation varies among individuals, but the disease almost always involves the rectum. Ulcerative colitis has required evaluation by colonoscopy to determine the extent and severity of the disease. The PillCam platform offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the PillCam platform include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the PillCam platform may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon.

The PillCam® SB capsule (formerly M2A® Capsule) that was FDA-approved in August 2001 for small bowel evaluation has been ingested to date by more than 700,000 people worldwide and is well accepted by patients and physicians as well as the professional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. Further details of the PillCam® Colon Capsule Endoscope (PCCE) can be found in the device description section.

In previous studies, the PillCam colon platform has been shown to be safe and to be able to demonstrate colon polyps and cancers. This study is an extension to a trial evaluating the use of PCCE in ulcerative colitis that has already been completed in Hong Kong (n=40). This study is designed to assess the ability of the capsule to accurately detect inflammatory lesions and thus classifying the extent and severity of disease in subjects with ulcerative colitis in comparison to traditional colonoscopy.

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Hong Kong
- - Hong Kong, Hong Kong
    - Chinese university of Hong Kong, Princes of Walses Hospital
Singapore
- - Singapore, Singapore, 119074
    - Department of Medicine, National University Hospital
Taiwan
- - Taipei, Taiwan
    - Department of Internal Medicine & Health Management Center, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease

The study population will consist of subjects who fulfill all the inclusion criteria and none of the exclusion criteria.

Description

Inclusion Criteria:

Subjects 18-70
Suspected or known ulcerative colitis patients

Exclusion Criteria:

Subject has dysphagia
Subject has congestive heart failure
Subject who can not tolerate bowel preparation
Poor bowel preparation
Subject has renal insufficiency
Subject is known or is suspected to suffer from intestinal obstruction.
Subject has a cardiac pacemaker or other implanted electro-medical devices.
Subject is pregnant
Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
Subject has any condition, which precludes compliance with study and/or device instructions.
Subject suffers from life threatening conditions
Subject is currently participating in another clinical study
Subject has constipation (less than 3 bowel movements/week)
Subject has known slow gastric emptying time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
A Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Agreement level between capsule and colonoscopy in classifying colitis into the above (see section 3.1) categories. Time Frame: within 7 days	within 7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number, type and severity of adverse events with both PCCE and standard colonoscopy Time Frame: Within 7 days	Within 7 days
Accuracy parameters for detecting active UC Time Frame: within 7 days	within 7 days
Disease severity scoring index for both PCCE and .standard colonoscopy Time Frame: within 7 days	within 7 days
Colon cleansing level score for both PCCE and standard colonoscopy. Time Frame: within 7 days	within 7 days
Grading of the bubbles interference at the colon for PCCE. Time Frame: Within 7 days	Within 7 days
Percentage of excreted colon capsules Time Frame: Within 7 Days	Within 7 Days
PCCE transit time from ingestion to excretion and colon transit time Time Frame: Within 7 Days	Within 7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Investigators

Principal Investigator: Josef Sung, Prof., Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified