Clinical trial NCT01433042: PillCam SB3 Capsule- Feasibility Study
Official title: Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small/Large Bowel
Keywords: small bowel disease
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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

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 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

Primary outcomes:
measure: Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians
timeFrame: up to 6 months from end of recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Bikur Holim medical center
city: Bucharest
country: Romania
facility: University Hospital
city: Pamplona
country: Spain
facility: Servicio de Digestivo Hospital de Navarra
city: Lund
country: Sweden
facility: Skane University Hospital, Lund University
Study officials:
affiliation: Medtronic - MITG
name: Samuel Adler, Prof
role: PRINCIPAL_INVESTIGATOR
References: