PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon - Full Text View

Sponsored by:	Given Imaging Ltd.
Information provided by:	Given Imaging Ltd.
ClinicalTrials.gov Identifier:	NCT00604162

Purpose

PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.

Condition
Colonic Diseases

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

Resource links provided by NLM:

MedlinePlus related topics: Colonic Diseases Colonoscopy Endoscopy

U.S. FDA Resources

Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:

Diagnostic yield of PCCE compared to standard colonoscopy [ Time Frame: WITHIN 7 DAYS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number, type and severity of adverse events [ Time Frame: WITHIN 7 DAYS ] [ Designated as safety issue: Yes ]
Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE, compared to standard colonoscopy [ Time Frame: WITHIN 7 DAYS ] [ Designated as safety issue: No ]
Colon cleansing level score (index) [ Time Frame: WITHIN 7 DAYS ] [ Designated as safety issue: No ]
Percentage of excreted colon capsules [ Time Frame: WITHIN 7 DAYS ] [ Designated as safety issue: No ]
PCCE transit time per section (stomach, small bowel, colon) [ Time Frame: WITHIN 7 DAYS ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	392
Study Start Date:	October 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.

Detailed Description:

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. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. Further details of the PillCam™ Colon Capsule Endoscope (PCCE) can be found in the device description section.

This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

suspected and known colonic disease patients

Criteria

Inclusion Criteria:

Subject was referred for colonoscopy for one of the following reasons:
- Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits, or diarrhea/constipation of recent onset.
- Any subject ≥ 18 years of age with:
  - Positive findings in the colon on a GI radiographic study
  - Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy
  - Suspected or known ulcerative colitis

Exclusion Criteria:

Subject has dysphagia
Subject has congestive heart failure
Subject has renal insufficiency
Subject is known or is suspected to suffer from intestinal obstruction.
Chronic use of laxatives
Subject has a cardiac pacemakers or other implanted electro medical devices.
Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
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.
Age < 18 years
Subject suffers from life threatening conditions
Subject is currently participating in another clinical study
Subject has known slow gastric emptying time

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604162

Locations

France
CHU Lyon
Lyon, France
CHU Nancy
Nancy, France
Germany
Evangelisches Krankenhaus
Dusseldorf, Germany
AK Altona
Hamburg, Germany
Italy
Ospedale Gemelli
Rome, Italy
Spain
Clinica Universitaria de Navarra
Pamplona, Spain
United Kingdom
St.Marks&Northwick Park hospital
Harrow, United Kingdom

Sponsors and Collaborators

Given Imaging Ltd.

Investigators

Principal Investigator:

Jacques DEVIERE, M.D

Hôpital Erasme

More Information

No publications provided

Responsible Party:	Given Imaging Ltd. ( Yael Koren )
Study ID Numbers:	MA-53
Study First Received:	January 24, 2008
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00604162 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; United Kingdom: National Health Service; Germany: Federal Institute for Drugs and Medical Devices; Italy: National Institute of Health; Spain: Spanish Agency of Medicines

Keywords provided by Given Imaging Ltd.:

Suspected colonic disease
Known colonic disease

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 02, 2009