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

NCT04364386 | Completed Results FDA Device

• 1 other identifier: P-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Post Partum Hemorrhage

Keywords

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (3)

• Number of Related SAE

  Number of device related SAEs

  6 weeks

• Number of Participants With Damage to Cervix, Uterus or Vagina

  Number of any observable damage to cervix, uterus, vagina

  During the procedure

• Number of Participants With Uterine Inversion or Folding

  Number of uterine inversion or folding during procedure

  During the procedure

Secondary Outcomes (4)

• Number of Participants With User Feedback on Placement of InPress

  During the procedure

• Number of Participants With User Feedback on Connection to Vacuum

  During the procedure

• Time to Uterine Contraction

  During the procedure

• Time

  During the procedure

Study Arms (1)

InPress

EXPERIMENTAL

Treatment with InPress Device for Postpartum Hemorrhage

Device: InPress Device

Interventions

InPress Device DEVICE

Treatment with InPress Device for Postpartum Hemorrhage

InPress

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who have just delivered a baby.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alydia Health: lead

Study Sites (2)

Dr. Cipto Mangunkusumo Hospital

Jakarta, Indonesia

Location

RSIA Budi Kemuliaan Hospital

Jakarta, Indonesia

Location

Related 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.

  PMID: 27275795 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jan Segnitz, MD
• Organization: InPress Technologies Inc

jsegnitz@gmail.com

(408) 238-9279

Study Officials

• Yuditiya Purwosunu, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: April 28, 2020
• Study Start: July 27, 2014
• Primary Completion: February 11, 2015
• Study Completion: April 1, 2015
• Last Updated: September 19, 2024
• Results First Posted: May 30, 2023

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)