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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PillCam COLON and Colonoscopy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillCam COLON | Device | 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. |
| 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. |
| 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:
|
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques DEVIERE, M.D | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lyon | Lyon | France | ||||
| CHU Nancy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19605831 | Result | 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. |
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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.
8 Hospital sites
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events Related to Colonoscopy | AE related to colonoscopy procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hila Debby | Given Imaging | +972 4 9097774 | Hila.Debby@givenimaging.com |
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| Standard colonoscopy | Procedure | 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. |
|
| 1 day |
| 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 |
| Nancy |
| France |
| Evangelisches Krankenhaus | Düsseldorf | Germany |
| AK Altona | Hamburg | Germany |
| Ospedale Gemelli | Rome | Italy |
| Clinica Universitaria de Navarra | Pamplona | Spain |
| St.Marks&Northwick Park hospital | Harrow | United Kingdom |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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:
| Posted | Number | 95% Confidence Interval | Percentage of Participants | 1 day |
|
|
|
| Secondary | Number, Type and Severity of Adverse Events | Not Posted | Within 7 days | Participants |
| Secondary | Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy | Not Posted | within 7 days | Participants |
| Secondary | Percentage of Excreted Colon Capsules | Not Posted | Within 7 days | Participants |
| Primary | 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. | Participants in the Accuracy Analysis successfully had both capsule endoscopy and colonoscopy. | Posted | Number | participants | 1 day |
|
|
|
| Primary | 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. | Accuracy Analysis population had both successful capsule endoscopy and colonoscopy. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 1 day |
|
|
|
| Secondary | Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon) | Not Posted | within 7 days | Participants |
| Primary | 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. | Accuracy Analysis population had both successful capsule endoscopy and colonoscopy. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 1 day |
|
|
|
| 0 |
| 328 |
| 0 |
| 328 |
| EG001 | Adverse Events Related to the Capsule | AE related to the capsule endoscopy procedure | 0 | 328 | 0 | 328 |
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| Title | Measurements |
|---|---|
|
| Polyp, >= 10 mm |
|
| Adenoma, >= 6 mm |
|
| Adenoma, >= 10 mm |
|
| Advanced Adenoma, Any Size |
|
| Advanced Adenoma, >= 6 mm |
|
| Advanced Adenoma, >= 10 mm |
|
| Colorectal Cancer |
|
| Title | Measurements |
|---|---|
|
| Polyp, >= 10 mm (n=50) |
|
| Adenoma, >= 6 mm (n=71) |
|
| Adenoma, >= 10 mm (n=45) |
|
| Advanced Adenoma, Any Size (n=52) |
|
| Advanced Adenoma, >= 6 mm (n=49) |
|
| Advanced Adenoma, >= 10 mm (n=45) |
|
| Colorectal Cancer (n=19) |
|
| Title | Measurements |
|---|---|
|
| Polyp, >= 10 mm (n=270) |
|
| Adenoma, >= 6 mm (n=249) |
|
| Adenoma, >= 10 mm (n=275) |
|
| Advanced Adenoma, Any Size (n=268) |
|
| Advanced Adenoma, >= 6 mm (n=271) |
|
| Advanced Adenoma, >= 10 mm (n=275) |
|
| Colorectal Cancer (n=301) |
|