Small/Large Bowel
Conditions
Keywords
small bowel disease
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
Interventions
DEVICEcapsule endoscopy
capsule endoscopy procedure
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians | 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 |
Countries
Israel, Romania, Spain, Sweden
Participant flow
Recruitment details
All patients enrolled in this study were indicated to undergo SB capsule endoscopy and/or had symptoms suggestive of SB disease. 225 patients were enrolled in this study recruitment period: August 2011 till September 2012. recruitment performed at Gastroenterlogy clinics and departments
Pre-assignment details
After obtaining the consent, subjects were assessed for eligibility to participate based on the eligibillity criteria. Each patient underwent a PillCam SB3 procedure. Preparation for the procedure included a 12 hours fast prior to the PillCam SB3ingestion. Patients were allowed to drink clear liquids 2 hours and eat 4 hours post ingestion.
Participants by arm
| Arm | Count |
|---|---|
| Capsule Endoscopy capsule endoscopy : capsule endoscopy procedure | 225 |
| Total | 225 |
Baseline characteristics
| Characteristic | Capsule Endoscopy |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 67 Participants |
| Age, Categorical Between 18 and 65 years | 157 Participants |
| Age, Continuous | 52.4 years STANDARD_DEVIATION 18.6 |
| Region of Enrollment Israel | 76 participants |
| Region of Enrollment Romania | 19 participants |
| Region of Enrollment Spain | 66 participants |
| Region of Enrollment Sweden | 64 participants |
| Sex: Female, Male Female | 112 Participants |
| Sex: Female, Male Male | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 225 |
| serious Total, serious adverse events | 1 / 225 |
Outcome results
Primary
Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians
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
Population: Five (2%) cases were excluded from the efficacy analysis due to the following :~* 1 patient withdrawn prior to any procedure.~* 1 patient did not meet the inclusion criteria~* 3 cases, the capsule remained in the stomach during the entire procedure.~Therefore, 220 cases are included in the efficacy analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capsule Endoscopy | Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians | 98 percentage of cases |
Comparison: Primary Endpoint~o Physician's subjective assessment questionnaire was evaluated in a quality manner.~The physicians were required to assess the performance of SB3 system as compare to SB2 by answering a short questionnaire.~The physicians were requested to indicate whether capsule SB3 was better as compared to SB2.percentage