Status:
COMPLETED
PillCam SB3 Capsule- Feasibility Study
Lead Sponsor:
Medtronic - MITG
Conditions:
Small/Large Bowel
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 creat...
Detailed Description
* 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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patient age is ≥ 18 years old,
- Patients with history suggestive and /OR symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy,
- Patient and/or legal guardian is able and agrees to sign the Informed Consent Form
- Exclusion criteria
- Patient has dysphagia,
- Patient is known or is suspected to suffer from intestinal obstruction,
- Patient has known previous stricture/obstruction of the SB or colon,
- Patient has a cardiac pacemakers or other implanted electro medical devices, 5. Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception,
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01433042
Start Date
August 1 2011
End Date
October 1 2012
Last Update
August 1 2019
Active Locations (4)
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1
Bikur Holim medical center
Jerusalem, Israel
2
University Hospital
Bucharest, Romania
3
Servicio de Digestivo Hospital de Navarra
Pamplona, Spain
4
Skane University Hospital, Lund University
Lund, Sweden