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This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy.
This study will also use to evaluate the administrative feasibility and data management of study design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PillCam Colon 2 and Standard Colonoscopy | Other | All subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillCam Colon 2 | Device | Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE). Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | Up to 6 weeks |
| Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Rex, Prof. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reporting Group | This was a single center study where 30 patients were enrolled. No formal sample sizing has been performed as this study was a pilot for a larger multicenter trial. All subjects that were enrolled in this study were indicated and scheduled to undergo colonoscopy based on their age and demographics for screening for polyps. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reporting Group | This was a single center study where 30 patients were enrolled. No formal sample sizing has been performed as this study was a pilot for a larger multicenter trial. All subjects that were enrolled in this study were indicated and scheduled to undergo colonoscopy based on their age and demographics for screening for polyps. |
| 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 | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | The accuracy parameters were calculated per subject analysis, i.e. the accuracy events were generated by the larger polyp identified in a given subject. | Posted | Number | 95% Confidence Interval | percentage of sensitivity | Up to 6 weeks |
|
Adverse events were collected and documented until the end of Colonoscopy procedure, which was scheduled 4-6 weeks after the PillCam Colon 2 CE procedure and was the end of the study.
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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 | PillCam Colon 2 and Standard Colonoscopy | All subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alergic reaction to adhesive | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Related to capsule procedure |
This was a feasibility study, in accordance with the definition of a feasibility study within the ACT checklist. The feasibility study was used as preparation to study pivotal study number MA- 204 NCT01372878 which has results posted on CT.gov.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hilla Debby/ Director of Clinical Affairs | Givenimaging | 97299077740 | 77740 | hila.debby@medtronic.com |
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| ID | Term |
|---|---|
| D011127 | Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Colonoscopy | Device | The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE. |
|
| Up to 6 weeks |
| Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | Up to 6 weeks |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Thirty patients were enrolled in the study. | Count of Participants | Participants |
|
| OG001 | PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp | All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp >= 10mm |
|
|
| Primary | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | The accuracy parameters were calculated per subject analysis, i.e. the accuracy events were generated by the larger polyp identified in a given subject. | Posted | Number | 95% Confidence Interval | percentage of specificity | Up to 6 weeks |
|
|
|
| Secondary | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | The accuracy parameters were calculated per segment analysis, i.e. the accuracy events were generated by the larger polyp identified in a given location (5 segments). | Posted | Number | 95% Confidence Interval | percentage of sensitivity | Up to 6 weeks |
|
|
|
| Secondary | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity | PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard. | The accuracy parameters were calculated per segment analysis, i.e. the accuracy events were generated by the larger polyp identified in a given location (5 segments). | Posted | Number | 95% Confidence Interval | percentage of specificity | Up to 6 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 6 |
| 30 |
|
| Globus Hystericus | Gastrointestinal disorders | Non-systematic Assessment | Related to capsule procedure |
|
| abdominal pain | General disorders | Non-systematic Assessment | Related to colon prep |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment | Related to colon prep |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment | Related to colon prep |
|
| headache | Gastrointestinal disorders | Non-systematic Assessment | Related to prep |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment | Related to colon prep |
|
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| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |