Clinical trial NCT00440791: Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Official title: Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colonic Diseases
Keywords: Colon
colonic disease
capsule endoscopy
Suspected or known colonic disease
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Minneapolis
country: United States
facility: Minnesota Gastroenterology
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New York
country: United States
facility: Private Medical Facility
state: New York
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Indiana University Hospital
name: Douglas Rex, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Glenn Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Rami Eliakim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Jonathan Leighton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Chris Gostout, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Elizabeth Rajan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Medical Facility
name: Blair Lewis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota Gastroenterology
name: S Ketover, MD
role: PRINCIPAL_INVESTIGATOR
References: