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

NCT ID: NCT00440791

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-07-31

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)

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

Conditions

Colonic Diseases

Study Design

• Study Time Perspective: PROSPECTIVE

Interventions

PillCam Colon capsule endoscopy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Principal Investigators

Douglas Rex, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University Hospital

Glenn Eisen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Rami Eliakim, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Jonathan Leighton, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Chris Gostout, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Elizabeth Rajan, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Blair Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Private Medical Facility

S Ketover, MD

Role: PRINCIPAL_INVESTIGATOR

Minnesota Gastroenterology

Locations

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Indiana University Hospital

Indianapolis, Indiana, United States

Minnesota Gastroenterology

Minneapolis, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Private Medical Facility

New York, New York, United States

Oregon Health Sciences University

Portland, Oregon, United States

Rambam Medical Center

Haifa, , Israel

Countries

United States; Israel

Other Identifiers

MA-54

Identifier Type: -

Identifier Source: org_study_id