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

Post Partum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364386
• Other study ID #: P-001
• Status: Completed
• Phase: N/A
• Start date: July 27, 2014
• Est. completion date: April 1, 2015

Study information

• Verified date: July 2022
• Source: Alydia Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 1, 2015
• Est. primary completion date: February 11, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Device:
• InPress Device
Treatment with InPress Device for Postpartum Hemorrhage

Locations

Country	Name	City	State
Indonesia	Dr. Cipto Mangunkusumo Hospital	Jakarta
Indonesia	RSIA Budi Kemuliaan Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Alydia Health

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Related SAE	Rate of device related SAEs	6 weeks
Primary	Rate of Damage to Cervix, Uterus or Vagina	Rate of any observable damage to cervix, uterus, vagina	Procedure
Primary	Rate of Occurrence of Uterine Inversion of Folding	Rate of uterine inversion or folding during procedure	Procedure
Secondary	User Feedback on Placement of InPress	Rate of positive user feedback on placement transvaginally	Procedure
Secondary	User Feedback on Connection to Vacuum	Rate of positive user feedback on connection to vacuum and maintenance of desired negative pressure	Procedure
Secondary	Rate of Uterine Contraction	Rate of Uterine contraction to a level that reduces or stops blood flow	Procedure
Secondary	Time	Time from insertion to removal of the device	Procedure