Capsule Endoscopy in Cystic Fibrosis
Recruitment status was: Recruiting
|Study Design:||Time Perspective: Prospective|
|Official Title:||Capsule Endoscopy in Cystic Fibrosis-Screening for Small Bowel Disease in Cystic Fibrosis Patient.|
- We will examine the entire small bowel
- of CF opatients
|Study Start Date:||July 2006|
|Estimated Study Completion Date:||July 2007|
The capsule endoscope system (Given Imaging, Ltd.) consists of 3 elements: a disposable capsule (PillCamTM SB) that acquires video images during natural propulsion through the digestive system.
The video-capsule PillCamTM SB has been cleared by the FDA for use in patients over 10 years of age for the detection of small intestinal disorders. It has been used in patients under age 10 and has been placed with the use of a gastroscope in patients unable to swallow the capsule. In fact, a new delivery device has been introduced recently that facilitates placement of the video-capsule in pediatric patients.For the purposes of this study, only patients over age 10 years who are able to swallow the capsule would be enrolled.
There are approximately 450 CF patients in the registry in Israel, with about 300 above the age of 10. Study subjects would be enrolled from this registry population and would be screened for the presence of the contraindications noted above. Patients would be assessed for symptoms of possible small bowel lesions at the time of enrollment including gastrointestinal bleeding, palpable abdominal mass, weight loss, diarrhea, and abdominal pain. Markers of inflammation including stool calprotectin will be assessed in all patients. These data would be recorded for further analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333957
|Hadassah Medical Organization|
|Jerusalem, Israel, 91240|
|Principal Investigator:||Michael Wilschanski, MBBS||Hadassah Medical Organization|