Ignite Creation Date:
2024-10-26 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502353
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-26
Brief Title:
Plexaa For Preconditioning Gender Affirming Mastectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device BLOOM43 for Gender Affirming Mastectomy - a Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P4PGAM
Brief Summary:
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device BLOOM43 in transgender and non-binary patients undergoing gender affirming mastectomy This study aims to understand a participants experience of the device including its usability and acceptability
Participants will use the device to precondition their right breast the evening before undergoing surgery gender affirming mastectomy
Participants will use the device to precondition their right breast the evening before undergoing surgery gender affirming mastectomy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None