Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333957
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2006-06-05
Brief Title:
Capsule Endoscopy in Cystic Fibrosis
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Capsule Endoscopy in Cystic Fibrosis-Screening for Small Bowel Disease in Cystic Fibrosis Patient
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 patientsFor 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
Page
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 patientsFor 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
Page
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None