Ignite Creation Date:
2024-05-06 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03475485
Status:
COMPLETED
Last Update Posted:
2018-06-11
First Post:
2018-03-18
Brief Title:
ID-Cap System Under Direct Observation
Sponsor:
EtectRX Inc
Organization:
EtectRX Inc
Study Overview
Official Title:
Clinical Performance of the ID-Cap System an Ingestion Event Marker in the Clinical Setting as an Aid to Measure Medication Adherence
Status:
COMPLETED
Status Verified Date:
2018-06
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:
The ID-Cap System is classified as an ingestion event marker IEM a Class II medical device The system is intended to record time-stamped ingestions with the ingestible sensor ID-Tag which transmits a signal to a wearable device the ID-Cap Reader In this study 36 subjects will ingest capsules containing ingestible sensors while wearing the Reader and being observed in a clinic setting
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None