Clinical trial NCT04364386: Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage
Official title: Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Partum Hemorrhage
Keywords: Post Partum Hemorrhage
Lead sponsor: Alydia Health
Sponsor class: INDUSTRY
First posted: 2020-04-28
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Related SAE
timeFrame: 6 weeks
measure: Number of Participants With Damage to Cervix, Uterus or Vagina
timeFrame: During the procedure
measure: Number of Participants With Uterine Inversion or Folding
timeFrame: During the procedure
Secondary outcomes:
measure: Number of Participants With User Feedback on Placement of InPress
timeFrame: During the procedure
measure: Number of Participants With User Feedback on Connection to Vacuum
timeFrame: During the procedure
measure: Time to Uterine Contraction
timeFrame: During the procedure
measure: Time
timeFrame: During the procedure
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dr. Cipto Mangunkusumo Hospital
city: Jakarta
country: Indonesia
facility: RSIA Budi Kemuliaan Hospital
Study officials:
affiliation: Indonesia University
name: Yuditiya Purwosunu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Purwosunu Y, Sarkoen W, Arulkumaran S, Segnitz J. Control of Postpartum Hemorrhage Using Vacuum-Induced Uterine Tamponade. Obstet Gynecol. 2016 Jul;128(1):33-36. doi: 10.1097/AOG.0000000000001473.