PillCam SB3 Capsule- Feasibility Study
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|ClinicalTrials.gov Identifier: NCT01433042|
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : February 4, 2014
Last Update Posted : February 4, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Small/Large Bowel||Device: capsule endoscopy||Not Applicable|
- Purpose of study- To assess the performance of PillCam SB3 capsule in detecting small bowel lesions in patients
- Study design- Feasibility study
- Number of subjects- Up to 200
- Subject population- Patients with symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy
- No of centers- 4
- Duration of enrollment up to 12 months from IRB approval to enroll study patients
- Duration of follow-up 1 week after capsule procedure.
- Primary objectives To evaluate the performance of SB-3 system in patients as per physician questionnaire
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||225 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
|Experimental: capsule endoscopy||
Device: capsule endoscopy
capsule endoscopy procedure
Other Name: CE
- Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians [ Time Frame: up to 6 months from end of recruitment ]precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433042
|Bikur Holim medical center|
|Servicio de Digestivo Hospital de Navarra|
|Skane University Hospital, Lund University|
|Principal Investigator:||Samuel Adler, Prof||Given Imaging Ltd.|