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

PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon (MA-53)

This study has been completed.

Study NCT00604162 Information provided by Given Imaging Ltd.

First Received on January 24, 2008. Last Updated on January 23, 2011 History of Changes

Results First Received: July 7, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Diagnostic
Condition:	Colonic Diseases
Interventions:	Device: PillCam COLON Procedure: Standard colonoscopy

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
8 Hospital sites

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four patients withdrew before completing the study documents and were not included in the analysis.An additional 8 patients were not included in the analysis of the accuracy of polyp detection.

Reporting Groups

	Description
Colon Capsule Endoscopy, Then Standard Colonoscopy	Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison.

Participant Flow: Overall Study

	Colon Capsule Endoscopy, Then Standard Colonoscopy
STARTED	332
COMPLETED	328
NOT COMPLETED	4
Physician Decision	3
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
Colon Capsule Endoscopy, Then Standard Colonoscopy	Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison.

Baseline Measures

	Colon Capsule Endoscopy, Then Standard Colonoscopy
Number of Participants [units: participants]	328
Age [units: participants]
<=18 years	0
Between 18 and 65 years	227
>=65 years	101
Age [units: years] Mean ± Standard Deviation	58.5 ± 12.1
Gender [units: participants]
Female	147
Male	181
Region of Enrollment [units: participants]
France	96
Spain	63
Germany	49
Italy	53
United Kingdom	20
Belgium	47

Outcome Measures

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1. Primary:

Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies [ Time Frame: 1 day ]

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2. Primary:

Number of Participants With Indicated Lesions Detected by Standard Colonoscopy [ Time Frame: 1 day ]

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3. Primary:

Sensitivity of Capsule Endoscopy for Indicated Lesions [ Time Frame: 1 day ]

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4. Primary:

Specificity of Capsule Endoscopy for Indicated Lesions [ Time Frame: 1 day ]

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5. Secondary:

Percent of Participants With Scoring Index 3 or 4 [ Time Frame: 1 day ]

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6. Secondary:

Number, Type and Severity of Adverse Events [ Time Frame: Within 7 days ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

7. Secondary:

Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy [ Time Frame: within 7 days ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

8. Secondary:

Percentage of Excreted Colon Capsules [ Time Frame: Within 7 days ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

9. Secondary:

Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon) [ Time Frame: within 7 days ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Hila Debby
Organization: Given Imaging
phone: +972 4 9097774
e-mail: Hila.Debby@givenimaging.com

Publications of Results:

Van Gossum A, Navas MM, 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, Devière J. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med. 2009 Jul 16;361(3):264-70.

Responsible Party:	Hila Debby, Given Imaging Ltd.
ClinicalTrials.gov Identifier:	NCT00604162 History of Changes
Other Study ID Numbers:	MA-53
Study First Received:	January 24, 2008
Results First Received:	July 7, 2010
Last Updated:	January 23, 2011
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; United Kingdom: National Health Service; Germany: Federal Institute for Drugs and Medical Devices; Italy: National Institute of Health; Spain: Spanish Agency of Medicines