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Feasibility trial of the InPress Device to treat postpartum hemorrhage (PPH).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InPress | Experimental | Treatment with InPress Device for Postpartum Hemorrhage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InPress Device | Device | Treatment with InPress Device for Postpartum Hemorrhage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With User Feedback on Placement of InPress | Positive user feedback on placement transvaginally | During the procedure |
| Number of Participants With User Feedback on Connection to Vacuum |
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Inclusion Criteria:
Exclusion Criteria:
Women who have just delivered a baby.
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| Name | Affiliation | Role |
|---|---|---|
| Yuditiya Purwosunu, MD | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Cipto Mangunkusumo Hospital | Jakarta | Indonesia | ||||
| RSIA Budi Kemuliaan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27275795 | Result | 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. |
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No plan.
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| ID | Title | Description |
|---|---|---|
| FG000 | InPress | Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | InPress | Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Related SAE | Number of device related SAEs | Posted | Number | SAEs | 6 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | InPress | Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urine retention post extraction with forceps with infected opened perineal laceration | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jan Segnitz, MD | InPress Technologies Inc | (408) 238-9279 | jsegnitz@gmail.com |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 |
| Jakarta |
| Indonesia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Participants With Damage to Cervix, Uterus or Vagina | Number of any observable damage to cervix, uterus, vagina | Posted | Number | participants | During the procedure |
|
|
|
| Primary | Number of Participants With Uterine Inversion or Folding | Number of uterine inversion or folding during procedure | Posted | Number | participants | During the procedure |
|
|
|
| Secondary | Number of Participants With User Feedback on Placement of InPress | Positive user feedback on placement transvaginally | Posted | Number | participants | During the procedure |
|
|
|
| Secondary | Number of Participants With User Feedback on Connection to Vacuum | Positive user feedback on connection to vacuum and maintenance of desired negative pressure | Posted | Number | participants | During the procedure |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | During the procedure |
|
|
|
| Secondary | Time | Time from insertion to removal of the device | Posted | Mean | Standard Deviation | minutes | During the procedure |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
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| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |