Capsule Endoscopy in Cystic Fibrosis
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Purpose
Cystic Fibrosis patients continue to have bowel problems even after adequate pancreatic enzyme supplementation. There may be pathology of the lining of the bowel. Capsule endoscopy will be used to photograph the entire bowel.
| Condition |
|---|
|
Cystic Fibrosis |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 200 |
| 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.
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Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria would include those subjects with known CF who are able to give informed consent to undergo capsule endoscopy and whose guardians provide consent as well, if applicable. -
Exclusion Criteria
Subjects would be excluded if they were felt to be poor surgical candidates as patients may need to undergo surgery in the rare event of retention of the capsule. Patients genotype and lung function will be noted; patients will be excluded if FEV1 < 40%.
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Contacts and Locations| Contact: Michael Wilschanski, MBBS | 02-5844922 | michaelwil@hadassah.org.il |
| Contact: Hadas Lemberg, PhD | 00 972 2 6777572 | lhadas@hadassah.org.il |
| Israel | |
| Hadassah Medical Organization | Recruiting |
| Jerusalem, Israel, 91240 | |
| Contact: Hadassah Medical Organization Hadassah Medical Organization | |
| Principal Investigator: | Michael Wilschanski, MBBS | Hadassah Medical Organization |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00333957 History of Changes |
| Other Study ID Numbers: | will001-HMO-CTIL |
| Study First Received: | June 5, 2006 |
| Last Updated: | November 5, 2007 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Hadassah Medical Organization:
|
capsule endoscopy |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013