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

NCT ID: NCT04364386

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-27
• Study Completion Date: 2015-04-01

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.

Conditions

Post Partum Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

InPress

Treatment with InPress Device for Postpartum Hemorrhage

Group Type: EXPERIMENTAL

InPress Device

Intervention Type: DEVICE

Treatment with InPress Device for Postpartum Hemorrhage

Interventions

InPress Device

Treatment with InPress Device for Postpartum Hemorrhage

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alydia Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuditiya Purwosunu, MD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Dr. Cipto Mangunkusumo Hospital

Jakarta, , Indonesia

RSIA Budi Kemuliaan Hospital

Jakarta, , Indonesia

Countries

Indonesia

References

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.

Reference Type: RESULT

PMID: 27275795 (View on PubMed)

Other Identifiers

P-001

Identifier Type: -

Identifier Source: org_study_id