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Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure

This study has been completed.
Sponsor:
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00951587
First received: August 2, 2009
Last updated: March 10, 2010
Last verified: March 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of the night procedure in regards to colon cleansing level and capsule excretion rate.


Condition Intervention Phase
Colonic Diseases
 Device: PillCam™ (Capsule Endoscopy)
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure

Resource links provided by NLM:

U.S. FDA Resources

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 ]
  • Transit time in the different GI regions until excretion [ 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 ]
  • Number of complete capsule procedure [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • Patient subjective assessment questionnaires [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients that are indicated for colonoscopy or who are suspected or known to suffer from colonic diseases.
 Device: PillCam™ (Capsule Endoscopy)
Medical Device

Detailed Description:

The evaluation of subjects with suspected colonic disease includes endoscopic imaging by colonoscopy and radiologic imaging such as air-contrast barium enema, or CT colonography. The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, an ingestible 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 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 500,000 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 evaluate the level of cleanliness and visualization of colon achieved by colon capsule endoscopy when using Night procedure regimens for preparation of the colon.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subject is between the ages of 50-75 years and has an indication to undergo colonoscopy: At least 75% of total cases OR
  • Subject is 18-50 suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy (e.g. rectal bleeding, melena, positive FOBT, recent change of bowel habits, CRC screening, UC, positive findings on a GI radiographic study - no more than 25% of total cases

Exclusion criteria

  • Subject has dysphagia or any swallowing disorder
  • Subject has severe Congestive heart failure (NYHA II or IV)
  • Subject has 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 judgement of the investigator
  • Subject has a cardiac pacemaker or other implanted electromedical device.
  • 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 any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID enteropathy,
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951587

Locations
Germany
Berufsgenossenschaftliche Universitätskliniken Bergmannsheil
Bochum, Germany, 44789
Knappschaftskrankenhaus Medizinische Universitaetsklinik
Bochum, Germany, 44892
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Wolff Schmiegel, Prof. Dr. Knappschaftskrankenhaus Medizinische Universitaetsklinik
  More Information

No publications provided

Responsible Party: Corporate Manager Clinical Affiars, Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00951587     History of Changes
Other Study ID Numbers: MA-104
Study First Received: August 2, 2009
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
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013