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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:
NCT00885235
First received: April 20, 2009
Last updated: August 2, 2009
Last verified: August 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of the PCCE preparation and procedure on colon cleansing level and excretion rate.


Condition
Bowel 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:

U.S. FDA Resources

Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • Colon cleansing level score for PCCE [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
  • Grading of visual interference from bubbles in the colon for PCCE [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
  • Number of colon capsules excreted over time [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
  • Capsule transit time from ingestion to entrance into the cecum & through the colon [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
  • Number, type and severity of adverse events [ Time Frame: WithIn 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Accuracy parameters (sensitivity, specificity ,NPV,PPV,LR) of PCCE in detecting polyps equal to or larger than 10mm as compared to colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • Accuracy parameters (sensitivity, specificity ,NPV,PPV,LR) of PCCE in detecting polyps equal to or larger than 6mm as compared to colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • The diagnostic yield of PCCE in detecting a variety of colonic lesions [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Subjects that are indicated for colonoscopy who are suspected or known to suffer from large bowel 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, or CT colonography. The PillCam® platform 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 radio frequency transmitter. Advantages of the PillCam® platform 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 PillCam® platform may be more readily accepted by patients and thereby improving compliance with colorectal cancer screening recommendations.

The PillCam® SB capsule (formerly M2A® Capsule) that was cleared by the FDA 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 major gastrointestinal professional organizations. 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 specifically designed capsule colonoscopy procedure allows for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the PillCam® platform 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 develop the optimal PCCE procedure by measuring the levels of cleanliness and capsule excretion rates. Furthermore, capsule endoscopy and colonoscopy procedures will be compared in regards to the detection of polyps and lesions in the colon.

  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

Subjects that are indicated for colonoscopy who are suspected or known to suffer from large bowel diseases.

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

Criteria

Inclusion Criteria:

  • Subjects over ≥ 50 years of age scheduled for colorectal cancer screening
  • 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.

  • Subject ≥ 18 years of age with one of the following:

    • Positive findings (≥ 10 mm polyps) in the colon on a GI radiographic study (BE, CT scan, etc) OR
    • Personal history of colorectal cancer (CRC) or adenomatous polyps and ≥5 years since last colonoscopy

Exclusion Criteria:

  • Subject has dysphagia or any swallowing disorder
  • Subject has congestive heart failure
  • Patient has significant renal insufficiency, heart disease or any other condition that the investigator would expect to increase the risk of complications from magnesium citrate, such as dehydration or electrolyte imbalance
  • 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 pacemaker or other implanted electro medical 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 with gastrointestinal motility disorders
  • Subject has known delayed gastric emptying
  • 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, or are of child-bearing potential and do not practice medically acceptable methods of contraception such as: surgical sterilization, approved hormonal contraceptives (i.e. birth control pills, Depo-Provera), barrier methods (i.e. condom or diaphragm) used with a spermicide and an intrauterine device (IUD)
  • 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: NCT00885235

Locations
United States, Indiana
University of Indiana Hospital
Indianapolis, Indiana, United States, 46202
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Digestive Care Inc.
Beavercreek, Ohio, United States, 45440
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Douglas Rex, Dr University of Indiana Hospital
Principal Investigator: Douglas Morgan, Dr University of North Carolina
  More Information

No publications provided

Responsible Party: Corporate Manager Clinical Affiars for Colon products, Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00885235     History of Changes
Other Study ID Numbers: MA-101
Study First Received: April 20, 2009
Last Updated: August 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Given Imaging Ltd.:
Bowel Diseases

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

ClinicalTrials.gov processed this record on May 16, 2013