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Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) Preparation and Procedure

This study has been completed.
Sponsor:
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00604292
First received: January 29, 2008
Last updated: March 10, 2010
Last verified: March 2010
  Purpose

To evaluate the effect of a modified preparation and procedure on colon cleansing level


Condition
Colonic Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the PillCam Colon Capsule Endoscopy Preparation and Procedure

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • Colon cleansing level score [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Accuracy parameters of PCCE, compared to colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases

Detailed Description:

The evaluation of subjects with suspected colonic disease includes endoscopic imaging by colonoscopy and radiologic imaging such as air-contrast barium enema, abdominal/pelvic CT, or virtual colonoscopy. The Given® Diagnostic System 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 Given® Diagnostic System 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 Given® Diagnostic System may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon and comply with colorectal cancer screening recommendations.

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 300,000 people worldwide and is well accepted by patients and physicians as well as the processional 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. 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 is a pilot study that is designed to compare capsule colonoscopy and colonoscopy procedures with respect to colon cleansing level and progression of colon capsule. Furthermore, the two procedures will be compared in regards to the detection of colon abnormalities.

  Eligibility

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

Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases

Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  • Subject is between the ages of 18-75 years.
  • Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy (rectal bleeding, melena, positive FOBT, recent change of bowel habits, CRC screening, UC, positive findings on a GI radiographic study)

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment:

  • Subject has dysphagia or any swallowing disorder
  • Subject has Congestive heart failure
  • Subject is known to suffer from diabetes
  • Subject has high degree of renal insufficiency
  • 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 a cardiac pacemakers or other implanted electromedical devices.
  • Subject has any allergy or other known contraindication to the medications used in the study
  • Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  • Subject with high risk for capsule retention: Crohn's disease, SB tumors, radiation enteritis, NSAID, surgical anastomosis,
  • Subject has any condition, which precludes compliance with study and/or device instructions.
  • 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 suffers from life threatening conditions
  • Subject currently participating in another clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604292

Locations
Germany
Klinikum Ludwigshafen gGMBH
Ludwigshafen, Bremserster 79, Germany
Evangelisches Krankenhaus
Duesseldorf, Germany
Allgemeines Krankenhaus Altona
Hamburg, Germany
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Juergen Riemann, Prof. Dr. Klinikum Ludwigshafen gGmbH
  More Information

No publications provided

Responsible Party: Corporate Director Clinical Affiars, Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00604292     History of Changes
Other Study ID Numbers: MA-102
Study First Received: January 29, 2008
Last Updated: March 10, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Given Imaging Ltd.:
Colonic Diseases

Additional relevant MeSH terms:
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014