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PillCam SB3 Capsule- Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433042
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Information provided by (Responsible Party):
Given Imaging Ltd.

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

Condition or disease Intervention/treatment Phase
Small/Large Bowel Device: capsule endoscopy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients
Study Start Date : August 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: capsule endoscopy Device: capsule endoscopy
capsule endoscopy procedure
Other Name: CE

Primary Outcome Measures :
  1. 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 ]
    precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01433042

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Bikur Holim medical center
Jerusalem, Israel
University Hospital
Bucharest, Romania
Servicio de Digestivo Hospital de Navarra
Pamplona, Spain
Skane University Hospital, Lund University
Lund, Sweden
Sponsors and Collaborators
Given Imaging Ltd.
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Principal Investigator: Samuel Adler, Prof Given Imaging Ltd.

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Responsible Party: Given Imaging Ltd. Identifier: NCT01433042     History of Changes
Other Study ID Numbers: RD-304
First Posted: September 13, 2011    Key Record Dates
Results First Posted: February 4, 2014
Last Update Posted: February 4, 2014
Last Verified: December 2013

Keywords provided by Given Imaging Ltd.:
small bowel disease