Back to resultsFeasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage
Primary Purpose
Post Partum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
InPress Device
Sponsored by
About this trial
This is an interventional device feasibility trial for Post Partum Hemorrhage focused on measuring Post Partum Hemorrhage
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.
Sites / Locations
- Dr. Cipto Mangunkusumo Hospital
- RSIA Budi Kemuliaan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
InPress
Arm Description
Treatment with InPress Device for Postpartum Hemorrhage
Outcomes
Primary Outcome Measures
Rate of Related SAE
Rate of device related SAEs
Rate of Damage to Cervix, Uterus or Vagina
Rate of any observable damage to cervix, uterus, vagina
Rate of Occurrence of Uterine Inversion of Folding
Rate of uterine inversion or folding during procedure
Secondary Outcome Measures
User Feedback on Placement of InPress
Rate of positive user feedback on placement transvaginally
User Feedback on Connection to Vacuum
Rate of positive user feedback on connection to vacuum and maintenance of desired negative pressure
Rate of Uterine Contraction
Rate of Uterine contraction to a level that reduces or stops blood flow
Time
Time from insertion to removal of the device
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04364386
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 27, 2014 (Actual)
Primary Completion Date
February 11, 2015 (Actual)
Study Completion Date
April 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alydia Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage
Keywords
Post Partum Hemorrhage
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
InPress
Arm Type
Experimental
Arm Description
Treatment with InPress Device for Postpartum Hemorrhage
Intervention Type
Device
Intervention Name(s)
InPress Device
Intervention Description
Treatment with InPress Device for Postpartum Hemorrhage
Primary Outcome Measure Information:
Title
Rate of Related SAE
Description
Rate of device related SAEs
Time Frame
6 weeks
Title
Rate of Damage to Cervix, Uterus or Vagina
Description
Rate of any observable damage to cervix, uterus, vagina
Time Frame
Procedure
Title
Rate of Occurrence of Uterine Inversion of Folding
Description
Rate of uterine inversion or folding during procedure
Time Frame
Procedure
Secondary Outcome Measure Information:
Title
User Feedback on Placement of InPress
Description
Rate of positive user feedback on placement transvaginally
Time Frame
Procedure
Title
User Feedback on Connection to Vacuum
Description
Rate of positive user feedback on connection to vacuum and maintenance of desired negative pressure
Time Frame
Procedure
Title
Rate of Uterine Contraction
Description
Rate of Uterine contraction to a level that reduces or stops blood flow
Time Frame
Procedure
Title
Time
Description
Time from insertion to removal of the device
Time Frame
Procedure
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women who have just delivered a baby.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuditiya Purwosunu, MD
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Cipto Mangunkusumo Hospital
City
Jakarta
Country
Indonesia
Facility Name
RSIA Budi Kemuliaan Hospital
City
Jakarta
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan.
Citations:
PubMed Identifier
27275795
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.
Results Reference
result
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Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage
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