Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05537818
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2022-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AVPI Migraine Study
Sponsor:
Nocira, LLC
Organization:
Study Overview
Official Title:
Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine: a Multicenter, Double-blind, Randomized, Sham-controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
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:
NC06
Brief Summary:
The study is designed as a multicenter, double-blind, randomized, sham-controlled trial to assess the safety and effectiveness of the Nocira AVPI Device for the acute treatment of migraine. The study is conducted in two phases in two study groups:
* Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and
* Phase II - for further evaluation when used in the home (non-clinical) environment.
* Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and
* Phase II - for further evaluation when used in the home (non-clinical) environment.
Detailed Description:
The study is designed as a multicenter, double-blind, randomized, sham-controlled trial to assess the safety and effectiveness of the Nocira AVPI Device for the acute treatment of migraine. The study is conducted in two phases in two study groups:
* Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and
* Phase II - for further evaluation when used in the home (non-clinical) environment.
The timing of enrollments into each group will vary between sequentially timed Phases I \& II. Group 1 subjects may participate in both Phases. Group 2 subjects participate only in Phase II.
Group 1 subjects may participate for up to 90 days (45 days for each of Phases I\&II). Group 2 subjects will participate for up to 45 days.
* Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and
* Phase II - for further evaluation when used in the home (non-clinical) environment.
The timing of enrollments into each group will vary between sequentially timed Phases I \& II. Group 1 subjects may participate in both Phases. Group 2 subjects participate only in Phase II.
Group 1 subjects may participate for up to 90 days (45 days for each of Phases I\&II). Group 2 subjects will participate for up to 45 days.
Study Oversight
Has Oversight DMC:
False
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?: