Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in Detection & Classification of Ulcerative Colitis

NCT00604422 | Completed

• 1 other identifier: MA-107
• Study Type: observational
• Target: 97
• Locations: 3 countries
• Sites: 3

Brief Summary

To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify Ulcerative colitis

Conditions

Colonic Disease; Ulcerative Colitis

Keywords

Colonic disease; Ulcerative colitis; suspected or known colonic disease

Outcome Measures

Primary Outcomes (1)

• Agreement level between capsule and colonoscopy in classifying colitis into the above (see section 3.1) categories.

  within 7 days

Secondary Outcomes (7)

• Number, type and severity of adverse events with both PCCE and standard colonoscopy

  Within 7 days

• Accuracy parameters for detecting active UC

  within 7 days

• Disease severity scoring index for both PCCE and .standard colonoscopy

  within 7 days

• Colon cleansing level score for both PCCE and standard colonoscopy.

  within 7 days

• Grading of the bubbles interference at the colon for PCCE.

  Within 7 days

Study Arms (1)

A

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects 18-70
• Suspected or known ulcerative colitis patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (3)

Chinese university of Hong Kong, Princes of Walses Hospital

Hong Kong, Hong Kong

Location

Department of Medicine, National University Hospital

Singapore, 119074, Singapore

Location

Department of Internal Medicine & Health Management Center, National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Colonic Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colitis; Gastroenteritis; Inflammatory Bowel Diseases

Study Officials

• Josef Sung, Prof.

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: January 30, 2008
• Study Start: April 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 31, 2019

Record last verified: 2010-03

Locations

HK (1); SG (1); TW (1)