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

Medtronic - MITG332 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

332

Conditions

Colonic Diseases

Interventions

PillCam COLONDEVICE

The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.

Standard colonoscopyPROCEDURE

Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (7)

CHU Lyon

Lyon, France

CHU Nancy

Nancy, France

Evangelisches Krankenhaus

Düsseldorf, Germany

AK Altona

Hamburg, Germany

Outcomes

Primary Outcomes

Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies

The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.

Time frame: 1 day

Number of Participants With Indicated Lesions Detected by Standard Colonoscopy

Since the standard colonoscopy is the "gold standard" to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger.

Time frame: 1 day

Sensitivity of Capsule Endoscopy for Indicated Lesions

Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.

Time frame: 1 day

Specificity of Capsule Endoscopy for Indicated Lesions

Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.

Time frame: 1 day

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes