Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT00333957
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2006-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Capsule Endoscopy in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2006-06-05', 'studyFirstSubmitQcDate': '2006-06-05', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'We will examine the entire small bowel'}, {'measure': 'of CF opatients'}]}, 'conditionsModule': {'keywords': ['capsule endoscopy'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThere 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.\n\nPage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion 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. -\n\nExclusion Criteria\n\nSubjects 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%.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00333957', 'briefTitle': 'Capsule Endoscopy in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Capsule Endoscopy in Cystic Fibrosis-Screening for Small Bowel Disease in Cystic Fibrosis Patient.', 'orgStudyIdInfo': {'id': 'will001-HMO-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '91240', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Michael Wilschanski, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}}}}