Clinical trial NCT00604162: PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Official title: Evaluation of PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonic Diseases
Keywords: Suspected colonic disease
Known colonic disease
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To see if PillCam COLON will demonstrate diagnostic yield \>80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.

Detailed description: The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease.

This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).

Eligibility criteria: Inclusion Criteria:

* Subject was referred for 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 Fecal Occoult Blood Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset.
  * Any subject ≥ 18 years of age with:

    * Positive findings in the colon on a GastroIntestinal (GI) radiographic study
    * Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy
    * Suspected or known ulcerative colitis

Exclusion Criteria:

* Subject has dysphagia
* Subject has congestive heart failure
* Subject has renal insufficiency
* Subject is known or is suspected to suffer from intestinal obstruction.
* Chronic use of laxatives
* Subject has a cardiac pacemakers or other implanted electro medical devices.
* Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
* 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 \< 18 years
* Subject suffers from life threatening conditions
* Subject is currently participating in another clinical study
* Subject has known slow gastric emptying time

Primary outcomes:
measure: Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies
timeFrame: 1 day
measure: Number of Participants With Indicated Lesions Detected by Standard Colonoscopy
timeFrame: 1 day
measure: Sensitivity of Capsule Endoscopy for Indicated Lesions
timeFrame: 1 day
measure: Specificity of Capsule Endoscopy for Indicated Lesions
timeFrame: 1 day
Secondary outcomes:
measure: Percent of Participants With Scoring Index 3 or 4
timeFrame: 1 day
measure: Number, Type and Severity of Adverse Events
timeFrame: Within 7 days
measure: Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy
timeFrame: within 7 days
measure: Percentage of Excreted Colon Capsules
timeFrame: Within 7 days
measure: Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)
timeFrame: within 7 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: CHU Lyon
city: Nancy
country: France
facility: CHU Nancy
city: Dusseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Hamburg
country: Germany
facility: AK Altona
city: Rome
country: Italy
facility: Ospedale Gemelli
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Harrow
country: United Kingdom
facility: St.Marks&Northwick Park hospital
Study officials:
affiliation: Hôpital Erasme
name: Jacques DEVIERE, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Gossum A, Munoz-Navas M, Fernandez-Urien I, Carretero C, Gay G, Delvaux M, Lapalus MG, Ponchon T, Neuhaus H, Philipper M, Costamagna G, Riccioni ME, Spada C, Petruzziello L, Fraser C, Postgate A, Fitzpatrick A, Hagenmuller F, Keuchel M, Schoofs N, Deviere J. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med. 2009 Jul 16;361(3):264-70. doi: 10.1056/NEJMoa0806347.