PillCam SB3 Capsule- Feasibility Study
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Purpose
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 | Intervention |
|---|---|
|
Small/Large Bowel |
Device: capsule endoscopy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients |
- Tissue coverage at fast transit areas, Image sharpness and colors, Image Illumination, Overall image quality [ Time Frame: up to 6 months from end of recruitment ] [ Designated as safety issue: No ]
- • Number of significant findings in the SB and duodenum detected by PillCam SB-3 [ Time Frame: up to 6 months from recruitment end ] [ Designated as safety issue: No ]
- Number, type and severity of adverse events [ Time Frame: up to 6 months from recruitment end ] [ Designated as safety issue: Yes ]
- Duration of reading time measured by physician subjective questionnaires of the entire video and of the small bowel part [ Time Frame: up to 6 months from recruitment end ] [ Designated as safety issue: No ]
| Enrollment: | 224 |
| Study Start Date: | August 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: capsule endoscopy |
Device: capsule endoscopy
capsule endoscopy procedure
Other Name: CE
|
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- 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Israel | |
| Bikur Holim medical center | |
| Jerusalem, Israel | |
| Romania | |
| University Hospital | |
| Bucharest, Romania | |
| Spain | |
| Servicio de Digestivo Hospital de Navarra | |
| Pamplona, Spain | |
| Sweden | |
| Skane University Hospital, Lund University | |
| Lund, Sweden | |
| Principal Investigator: | Samuel Adler, Prof | Given Imaging Ltd. |
More Information
No publications provided
| Responsible Party: | Given Imaging Ltd. |
| ClinicalTrials.gov Identifier: | NCT01433042 History of Changes |
| Other Study ID Numbers: | RD-304 |
| Study First Received: | September 7, 2011 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Given Imaging Ltd.:
|
small bowel disease |
ClinicalTrials.gov processed this record on May 16, 2013