Development of Applications of the Given® Diagnostic System and Evaluation of Their Performance
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to support the development of Given® Diagnostic System
      applications.
    

Detailed description: 
      This clinical study is designed to support the development of new generations of the Given®
      Diagnostic System and Agile™ Patency System that will accomplish better visualization, better
      diagnostic capabilities and will improve the system ease of use from the physician as well as
      patient's point of view.

      *The PillCam™ Capsules Capsule endoscopy using the PillCam™ capsule (Given Imaging Limited,
      Yoqneam, Israel) represents the newest imaging modality of the gastrointestinal tract without
      the need for invasive techniques, sedation, or radiation exposure1-35. Initially cleared for
      marketing in August 2001 as an adjunctive modality, the FDA in 2003 cleared PillCam™ SB
      (previously called M2A) as a stand alone tool for detecting small bowel abnormalities in
      those patients who meet the device's indications.

      The PillCam™ SB provides visualization of the entire small bowel mucosa and is presently
      purely a diagnostic test without therapeutic or biopsy potential.

      Before capsule endoscopy, enteroscopy was one of the methods for examining the small bowel
      tract, but the diagnostic value of this test for a wide variety of specific lesions is low
      due to inability to reach the entire length of the small bowel.

      Other endoscopic techniques include, Sonde enteroscopy, and intraoperative enteroscopy, but
      these are limited for several reasons including significant technical difficulties, length of
      procedures, potential risks, and frequently incomplete small bowel examination36-38. To date
      more than 400,000 PillCam™ SB capsules were ingested world wide. The Given® Diagnostic System
      (GDS) for Small Bowel is now the Gold standard.

      Additional PillCam™ capsules were developed and are used for diagnosing the Esophagus as well
      as the Colon.

      The PillCam™ ESO system received FDA clearance as well as the CE mark early 2005. To date,
      thousands of PillCam™ ESO capsules were ingested in both clinical trials and regular clinical
      setup worldwide with numerous published clinical studies39-45.

      The PillCam™ COLON capsule received CE marking on October 15th, 2006 and is cleared for
      marketing in Europe. It is now pending FDA clearance. To date, several hundreds of PillCam™
      COLON capsules were ingested in numerous pilot studies and ongoing multi-center studies in
      Europe and USA34-35.

      *The Agile™ Patency System Small and large bowel strictures are present in a large spectrum
      of diseases and clinical situations such as adhesion related diseases, Crohn's disease,
      patients who are post abdominal radiation treatment and patients who have undergone abdominal
      surgery46. Knowledge of intestinal patency in such patients will aid the physician in
      assessment and treatment of the patients.

      The current methods for identifying intestinal strictures primarily include small bowel
      follow through (SBFT), enteroclysis, computed tomography (CT) and enteroscopy but the
      diagnostic value of these tests is low. Advanced strictures are often missed and some of
      these methods include radiation and others are invasive.

      The Agile™ Patency System is designed to aid the gastroenterologist in verifying the patency
      of the GI tract. The system is essentially based on small identification tags, which are
      detected by radio frequency (RFID) encapsulated in a disintegrating capsule. The RFID tags
      have been marketed for many years for veterinary use. In animals they are injected
      sub-dermally and are used for life-long identification, marking and tracking47.

      Preliminary results demonstrate that the Agile System performs as intended48. Future
      developments of the unique technology which make up the Agile patency capsule will broaden
      its range of uses and applications beyond simple patency testing.

      Agile ingestions are estimated in the excess of three thousand worldwide.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of healthy volunteers who fulfill all the inclusion
        criteria and do not meet any of the exclusion criteria.
      
Keywords: Healthy people