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

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

Study Overview

• Status: Completed
• Conditions: Post Partum Hemorrhage
• Intervention / Treatment: Device: InPress Device

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Dr. Cipto Mangunkusumo Hospital
  • Jakarta, Indonesia
    • RSIA Budi Kemuliaan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InPress; Treatment with InPress Device for Postpartum Hemorrhage	Device: InPress Device; Treatment with InPress Device for Postpartum Hemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Related SAE	Number of device related SAEs	6 weeks
Number of Damage to Cervix, Uterus or Vagina	Number of any observable damage to cervix, uterus, vagina	During the procedure
Number of Uterine Inversion or Folding	Number of uterine inversion or folding during procedure	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Feedback on Placement of InPress	Positive user feedback on placement transvaginally	During the procedure
User Feedback on Connection to Vacuum	Positive user feedback on connection to vacuum and maintenance of desired negative pressure	During the procedure
Time to Uterine Contraction	Time to uterine contraction to a level that reduces or stops blood flow. Duration is exactly between 1 and 2 minutes for 1 participant, while the available data only suggests that it was less than 2 minutes for the rest of the participants but the exact duration cannot be narrowed down to 1-2 minutes.	During the procedure
Time	Time from insertion to removal of the device	During the procedure

Collaborators and Investigators

• Sponsor: Alydia Health
• Investigators: Principal Investigator: Yuditiya Purwosunu, MD, Indonesia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2014
• Primary Completion (Actual): February 11, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: April 25, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Post Partum Hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: P-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes