Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT01631435
Status:
COMPLETED
Last Update Posted:
2019-08-01
First Post:
2012-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PillCam® Platform With the PillCam Crohn's Disease Capsule
Sponsor:
Medtronic - MITG
Organization:
Study Overview
Official Title:
Evaluation of the PillCam® Platform With the PillCam Crohn's Disease Capsule in Visualization of Lesions in the Small Bowel and Colon That May Indicate Crohn's Disease
Status:
COMPLETED
Status Verified Date:
2015-03
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:
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).
Detailed Description:
This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have evidence of active symptoms associated with Crohn's disease. Each subject will be required to follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy procedure may be done the following day per physician discretion. If the ileocolonoscopy procedure is done within 24 hours from the CE procedure, the subject will stay on clear liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections below:
Visit 1; Screening visit
* Informed consent process
* screening for eligibility to participate in the study
* Inclusion/exclusion criteria
* Small bowel patency test
* Demographic data
* Pregnancy test
* General medical history
Visit 2; PillCam® Crohn's capsule ingestion
* PillCam® CD bowel preparation
* Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours)
* Ileocolonoscopy with intubation of terminal ileum
Follow up period (5-9 days following visit 2)
• CE Follow up telephone contac
Visit 1; Screening visit
* Informed consent process
* screening for eligibility to participate in the study
* Inclusion/exclusion criteria
* Small bowel patency test
* Demographic data
* Pregnancy test
* General medical history
Visit 2; PillCam® Crohn's capsule ingestion
* PillCam® CD bowel preparation
* Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours)
* Ileocolonoscopy with intubation of terminal ileum
Follow up period (5-9 days following visit 2)
• CE Follow up telephone contac
Study Oversight
Has Oversight DMC:
False
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?: