Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440791
Recruitment Status : Terminated (Interim analysis)
First Posted : February 27, 2007
Last Update Posted : August 3, 2007
Information provided by:
Given Imaging Ltd.

Brief Summary:
This multi-center, prospective, cohort study of 394 subjects that are indicated for standard colonoscopy due to suspected or known colonic disease examines the Given Diagnostic System and the PillCam Colon Capsule in comparison to standard colonoscopy. This study aims a. To evaluate and compare the accuracy of PillCam ™ Colon capsule endoscopy (PCCE) with standard colonoscopy. This study will evaluate the safety of PillCam ™ Colon capsule endoscopy (PCCE)

Condition or disease Intervention/treatment
Colonic Diseases Device: PillCam Colon capsule endoscopy

Detailed Description:

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 . This multi-center prospective, cohort study will evaluate the performance of PCCE in visualizing the colon. Up to 394 subjects will participate in this study. All subjects to be enrolled will be appropriate candidates for standard colonoscopy based on their clinical indication.

Each subject will undergo PCCE. All generated PCCE RAPID videos will be reviewed by blinded PCCE reading physicians. All readers, experienced in PillCam SB, will have undergone standardized training and passed a qualification test specific to reading and interpreting PCCE videos. Training will be done by reading at least 5 cases to demonstrate proficiency in interpretation of PCCE. PCCE results will be compared with that of a colonoscopy procedure.

Following PCCE procedure, standard colonoscopy will be performed by a colonoscopist blinded to the results of the PCCE. The colonoscopist will be "unblinded" during the standard colonoscopy procedure at three locations on withdrawal of the colonoscope.

Primary Endpoint - Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy.

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

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Study Start Date : June 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:

Subject was referred for standard 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

• Any subject over 18 years of age with:

  • Positive findings in the colon on a GI radiographic study (e.g., CT colonography, air-contrast barium enema, abdominal/pelvic CT scan)
  • Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 5 years since last colonoscopy or no sooner than 3 years prior to enrollment date as long as their prior colonoscopy revealed at least one of the following high risk conditions: multiple (greater than 3)adenomas, large adenoma (greater than 1 cm) , adenomas with a villous component, adenoma with high grade dysplasia.
  • Suspected or known ulcerative colitis

Exclusion criteria

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

  • Subject has dysphagia
  • Subject has congestive heart failure
  • 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.
  • Age less than 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00440791

United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Minnesota Gastroenterology
Minneapolis, Minnesota, United States, 55446
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Private Medical Facility
New York, New York, United States, 10128
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239-3098
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Given Imaging Ltd.
Principal Investigator: Douglas Rex, M.D. Indiana University Hospital
Principal Investigator: Glenn Eisen, M.D. Oregon Health and Science University
Principal Investigator: Rami Eliakim, MD Rambam Health Care Campus
Principal Investigator: Jonathan Leighton, MD Mayo Clinic
Principal Investigator: Chris Gostout, MD Mayo Clinic
Principal Investigator: Elizabeth Rajan, MD Mayo Clinic
Principal Investigator: Blair Lewis, MD Private Medical Facility
Principal Investigator: S Ketover, MD Minnesota Gastroenterology Identifier: NCT00440791     History of Changes
Other Study ID Numbers: MA-54
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: August 3, 2007
Last Verified: August 2007

Keywords provided by Given Imaging Ltd.:
colonic disease
capsule endoscopy
Suspected or known colonic disease

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