Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-28 @ 2:05 PM
Study NCT ID:
NCT04094558
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule
Status:
COMPLETED
Status Verified Date:
2022-06
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:
Prospective, open label trial to establish the ability of the SIMBA Capsule to accurately obtain a sample from the small bowel of participants with IBS (10 constipation-predominant (IBS-C) and 10 diarrhea-predominant (IBS-D)) and healthy participants (n=10). The accuracy of targeting the small bowel will be established by visual confirmation via X-ray. The clinical utility of the collected sample will be evaluated by analysis with samples obtained by the current gold standard (duodenal aspirate), as well as stool analysis and LBT.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: