Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01063231 | Evaluation of PillCam™ Colon 2 in Visualization of the Colon | PHASE3 | COMPLETED | 119 | — | — | Sep 1, 2009 | Oct 1, 2010 | Jul 31, 2019 | 8 | Belgium, France +5 |
| NCT00604162 | PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon | PHASE3 | COMPLETED | 332 | — | — | Oct 1, 2006 | Oct 1, 2007 | Aug 1, 2019 | 7 | France, Germany +3 |
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases. |
| 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 |
|---|---|---|
| PillCam™ (Capsule Endoscopy) Colon 2 capsule | DEVICE | Medical Device |
| 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. |
| 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. |
Inclusion criteria: * Subject is between the ages of 18-80 * Subject was referred to colonoscopy for at least one of the following reasons: * Colorectal cancer screening for age ≥50 * Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits...