Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2026-01-13 @ 5:14 AM
Study NCT ID:
NCT06476106
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-01
First Post:
2024-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Research Program Flight Thigh Cuff
Sponsor:
National Aeronautics and Space Administration (NASA)
Organization:
Study Overview
Official Title:
Mitigating Headward Fluid Shifts With Venoconstrictive Thigh Cuffs During Spaceflight
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
Venoconstrictive Thigh Cuffs (VTC) are being evaluated to determine the effectiveness at reversing the headward fluid shift that occurs during weightlessness. If successful, future studies may be done to implement these as a CM to SANS. To support this effort, participants will participate in 2 preflight study sessions consisting of a VTC fit check and a baseline data collection without and with the VTC donned. Participants will also participate in 3 inflight study sessions: a VTC fit check on flight day 30 (FD30) and two separate data collection sessions on flight day 45 (FD45) and 45 days before landing (R-45). During the two in-flight data collection days, participants will be studied before and for up to 6 hours after donning the VTC.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: