Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646653
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Feasibility Clinical Study of the Alma System in Treating Primary Postpartum Hemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Clinical Study of the Alma System in Treating Primary Postpartum Hemorrhage
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
Feasibility clinical study of the Alma System in treating primary postpartum hemorrhage PPH
Detailed Description:
10 subjects first in woman trial with ethics committee oversight Women who experienced postpartum hemorrhage will be treated with the Alma System which aims to rapidly reduce or stop the bleeding by targeting the primary cause uterine atony
The primary objective is to verify the safety of the Alma System in humans by 1 Ensuring the absence of serious adverse events SAEs related to the use of the Alma System during and after the procedure 2 Evaluating any observable damage to the uterus cervix or vagina due to the use of the Alma System 3 Evaluating the occurrence of uterine inversion or folding during the use of the Alma System
The secondary objectives include evaluating 1 The ability to easily place the Alma System trans-vaginally 2 The ability to connect the Alma System to a vacuum source and maintain the desired negative pressure 3 The ability of the Alma System to contract the uterus to a level that reduces or stops blood loss and avoids further non-surgical and surgical intervention 4 The time from insertion and start of negative pressure to a visible reduction in blood loss
The primary objective is to verify the safety of the Alma System in humans by 1 Ensuring the absence of serious adverse events SAEs related to the use of the Alma System during and after the procedure 2 Evaluating any observable damage to the uterus cervix or vagina due to the use of the Alma System 3 Evaluating the occurrence of uterine inversion or folding during the use of the Alma System
The secondary objectives include evaluating 1 The ability to easily place the Alma System trans-vaginally 2 The ability to connect the Alma System to a vacuum source and maintain the desired negative pressure 3 The ability of the Alma System to contract the uterus to a level that reduces or stops blood loss and avoids further non-surgical and surgical intervention 4 The time from insertion and start of negative pressure to a visible reduction in blood loss
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