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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Colonic Diseases

Intervention / Treatment
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* Device: PillCam COLON
* Procedure: Standard colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PillCam COLON and Colonoscopy<br>Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases, had capsule endoscopy with PillCam COLON after bowel preparation and before standard colonoscopy. | Device: PillCam COLON<br>* 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.<br>Procedure: Standard colonoscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Scoring Index 3 or 4 | Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows: poor cleansing level (Large amount of fecal residue.) fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.) good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.) excellent cleansing level (No more than small bits of adherent feces.) | 1 day | 
| Number, Type and Severity of Adverse Events |  | Within 7 days | 
| Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy |  | within 7 days | 
| Percentage of Excreted Colon Capsules |  | Within 7 days | 
| Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon) |  | within 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suspected colonic disease, Known colonic disease