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Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation, and therefore should improve diagnostic accuracy.
Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small bowel disease.
Preparation for procedure will include 12 hours fasting prior to the capsule ingestion
Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion.
Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of capsule performance will be captured
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| capsule endoscopy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capsule endoscopy | Device | capsule endoscopy procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians | precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians | up to 6 months from end of recruitment |
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Inclusion criteria:
Exclusion criteria
6. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule, 7. Patient 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, 8. Patient has any condition, which precludes compliance with study and/or device instructions, 9. Patient suffers from life threatening conditions, 10. Patient is currently participating in another clinical study, 11. Patient has known slow gastric emptying time
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Adler, Prof | Medtronic - MITG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bikur Holim medical center | Jerusalem | Israel | ||||
| University Hospital |
After obtaining the consent, subjects were assessed for eligibility to participate based on the eligibillity criteria. Each patient underwent a PillCam SB3 procedure. Preparation for the procedure included a 12 hours fast prior to the PillCam SB3ingestion.
Patients were allowed to drink clear liquids 2 hours and eat 4 hours post ingestion.
All patients enrolled in this study were indicated to undergo SB capsule endoscopy and/or had symptoms suggestive of SB disease. 225 patients were enrolled in this study recruitment period: August 2011 till September 2012. recruitment performed at Gastroenterlogy clinics and departments
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| ID | Title | Description |
|---|---|---|
| FG000 | Capsule Endoscopy | capsule endoscopy : capsule endoscopy procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
18 years and older patients with history suggestive and /or symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy and agreed to sign ICF
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| ID | Title | Description |
|---|---|---|
| BG000 | Capsule Endoscopy | capsule endoscopy : capsule endoscopy procedure |
| 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 | Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians | precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians | Five (2%) cases were excluded from the efficacy analysis due to the following :
Therefore, 220 cases are included in the efficacy analysis. | Posted | Number | percentage of cases | up to 6 months from end of recruitment |
|
two weeks after capsule procedure
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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 | Capsule Endoscopy | capsule endoscopy : capsule endoscopy procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Cardiovascular event | Cardiac disorders | Systematic Assessment | One serious Cardiovascular adverseevent -not related to capsule procedure was reported within this study: the patient died one day after capsule procedure as a result of cardiovascular event. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical affairs | Given Imaging Ltd. | +972-4-9097774 | Hila.Debby@givenimaging.com |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D053704 | Capsule Endoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
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| Bucharest |
| Romania |
| Servicio de Digestivo Hospital de Navarra | Pamplona | Spain |
| Skane University Hospital, Lund University | Lund | Sweden |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| 1 |
| 225 |
| 0 |
| 225 |
|
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| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |