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

This study has been terminated.
(Interim analysis)
Sponsor:
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00440791
First received: February 26, 2007
Last updated: August 1, 2007
Last verified: August 2007
  Purpose

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 Intervention
Colonic Diseases
Device: PillCam Colon capsule endoscopy

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Enrollment: 40
Study Start Date: June 2006
Study Completion Date: July 2007
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00440791

Locations
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
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00440791     History of Changes
Other Study ID Numbers: MA-54
Study First Received: February 26, 2007
Last Updated: August 1, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014