Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145808
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2005-09-01
Brief Title:
Wireless Capsule Endoscopy in Ulcerative Colitis
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Prospective Controlled Assessment of Wireless Capsule Endoscopy WCE in Ulcerative Colitis UC
Status:
COMPLETED
Status Verified Date:
2013-09
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:
Based on the inaccuracies of the current classification scheme for inflammatory bowel disease IBD the failure of surgical pouches and the findings of retrospective observational trials to date we hypothesize that a significant proportion of patients with UC will have small bowel involvement that will result in a change in diagnosis to CD or the recognition of a new phenotype of IBD The aim of this study is to determine the prevalence of small bowel pathology in patients diagnosed with UC using WCE This information will aid in the current efforts to re-classify IBD using improved endoscopic and imaging technologies genetic information and serologic information
Detailed Description:
Subjects will undergo both a blood draw and a wireless capsule endoscopy WCE
The blood draw will occur in the GI procedure unit on the day of subjects exam
WCE Subject will only consume a clear liquid diet after noon the day prior to the exam No food or beverage consumption any after 10 PM on the day before examination Not oral medications after 12 AMon the day of exam 8 hours before subjects exam
Day of exam subject will report to the endoscopy unit At that time subject will be prepared for examination by doctor who will apply a sensor array to the abdomen with adhesive sleeves In addition a waist belt device that holds the data recorder will be fitted to subject Subjects will swallow the capsule endoscope The capsule endoscope passes naturally through digestive tract while transmitting video images to the data recorder worn on the belt for approximately eight hours At this point subjects will be free to leave the University of Chicago hospital until they return eight hours later for disconnection of the recording equipment
Two hours after ingestion of the capsule subject will be able to resume a clear liquid diet Four hours after the studys start time subject will be able to resume a regular diet solid foods At this time subject will also be able to resume taking oral medications
After eight hours subject will return to the endoscopy suite DCAM 6H for disconnection of the recording equipment sensor array data recorder and belt The time that the capsule was ingested eating and drinking times and disconnection time as well as any discomfort subject experienced will be recorded
Subject will be contacted 72 hours after the examination to confirm passage of the capsule If they have not reported passage of the capsule with this time subject will undergo an abdominal radiograph in order to determine whether or not the capsule has passed
Subjects will be asked to identify a non-relative control spouses are acceptable within five years of their age and of similar background without Ulcerative Colitis There is an Information Handout that participating subjects will give to friends interested in participating If the subject does not find anyone they may still participate in this research study The study staff will try to find someone for them
The blood draw will occur in the GI procedure unit on the day of subjects exam
WCE Subject will only consume a clear liquid diet after noon the day prior to the exam No food or beverage consumption any after 10 PM on the day before examination Not oral medications after 12 AMon the day of exam 8 hours before subjects exam
Day of exam subject will report to the endoscopy unit At that time subject will be prepared for examination by doctor who will apply a sensor array to the abdomen with adhesive sleeves In addition a waist belt device that holds the data recorder will be fitted to subject Subjects will swallow the capsule endoscope The capsule endoscope passes naturally through digestive tract while transmitting video images to the data recorder worn on the belt for approximately eight hours At this point subjects will be free to leave the University of Chicago hospital until they return eight hours later for disconnection of the recording equipment
Two hours after ingestion of the capsule subject will be able to resume a clear liquid diet Four hours after the studys start time subject will be able to resume a regular diet solid foods At this time subject will also be able to resume taking oral medications
After eight hours subject will return to the endoscopy suite DCAM 6H for disconnection of the recording equipment sensor array data recorder and belt The time that the capsule was ingested eating and drinking times and disconnection time as well as any discomfort subject experienced will be recorded
Subject will be contacted 72 hours after the examination to confirm passage of the capsule If they have not reported passage of the capsule with this time subject will undergo an abdominal radiograph in order to determine whether or not the capsule has passed
Subjects will be asked to identify a non-relative control spouses are acceptable within five years of their age and of similar background without Ulcerative Colitis There is an Information Handout that participating subjects will give to friends interested in participating If the subject does not find anyone they may still participate in this research study The study staff will try to find someone for them
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