Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage

Alydia Health

Status

Completed

Conditions

Post Partum Hemorrhage

Treatments

Device: InPress Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT04364386

P-001

Details and patient eligibility

About

Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).

Full description

10 subjects in first in woman trial with ethics committee oversight. Women who developed postpartum hemorrhage were treated with the InPress Device. The intent of treatment was to quickly reduce or stop blood flow by addressing the driving cause of hemorrhage: uterine atony.

The primary objective is to verify the safety of the InPress Device in humans, including: 1. Absence of SAEs related to the use of the InPress Device intra- and post-procedure. 2. Evaluate any observable damage of the uterus, cervix, or vagina due to the use of the InPress Device. 3. Evaluate occurrence of uterine inversion or folding during the use of the InPress Device.

The secondary objectives include evaluations of: 1. Ability to easily place the InPress Device transvaginally. 2. Ability to connect the InPress Device to vacuum and maintain desired negative pressure. 3. Ability of InPress Device to contract the uterus to a level that reduces or stops blood loss and avoids further surgical intervention. 4. Evaluate time from insertion and start negative pressure to visible reduction of blood loss.

Enrollment

10 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
Female adult subjects (>18 years of age)
Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum >= 500 ml and according to the Investigator's judgment, require an intervention.

Exclusion criteria

Subjects who do not provide informed consent to participate in the clinical investigation.
Subjects who deliver at a uterus size < 34 weeks.
Subjects who have lost greater than 1000 ml of blood.
Subjects who have abnormal PT, PTT and INR
Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.