PillCam SB3 Capsule- Feasibility Study

Launched by MEDTRONIC - MITG · Sep 11, 2011

Keywords

ClinConnect Summary

* 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

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Patient age is ≥ 18 years old,
• • 2. Patients with history suggestive and /OR symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy,
• • 3. Patient and/or legal guardian is able and agrees to sign the Informed Consent Form
• • Exclusion criteria
• • 1. Patient has dysphagia,
• • 2. Patient is known or is suspected to suffer from intestinal obstruction,
• • 3. Patient has known previous stricture/obstruction of the SB or colon,
• • 4. 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

Trial Officials