Trial Outcomes & Findings for Feasibility Clinical Investigation Using the InPress Device for the Treatment of Postpartum Hemorrhage (NCT NCT04364386)

NCT ID: NCT04364386

Last Updated: 2024-09-19

Results Overview

Number of device related SAEs

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

6 weeks

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	InPress Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	InPress n=10 Participants Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage
Age, Continuous	25.2 years STANDARD_DEVIATION 6.2 • n=10 Participants
Sex: Female, Male Female	10 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=10 Participants
Region of Enrollment Indonesia	10 participants n=10 Participants

PRIMARY outcome

Timeframe: 6 weeks

Number of device related SAEs

Outcome measures

Outcome measures
Measure	InPress n=10 Participants Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage
Number of Related SAE	0 SAEs

PRIMARY outcome

Timeframe: During the procedure

Number of any observable damage to cervix, uterus, vagina

Outcome measures

Outcome measures
Measure	InPress n=10 Participants Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage
Number of Participants With Damage to Cervix, Uterus or Vagina	0 participants

PRIMARY outcome

Timeframe: During the procedure

Number of uterine inversion or folding during procedure

Outcome measures

Outcome measures
Measure	InPress n=10 Participants Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage
Number of Participants With Uterine Inversion or Folding	0 participants

SECONDARY outcome

Timeframe: During the procedure

Positive user feedback on placement transvaginally

Outcome measures

Outcome measures
Measure	InPress n=10 Participants Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage
Number of Participants With User Feedback on Placement of InPress	10 participants

SECONDARY outcome

Timeframe: During the procedure

Positive user feedback on connection to vacuum and maintenance of desired negative pressure

Outcome measures

Outcome measures
Measure	InPress n=10 Participants Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage
Number of Participants With User Feedback on Connection to Vacuum	9 participants

SECONDARY outcome

Timeframe: During the procedure

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.

Outcome measures

Outcome measures
Measure	InPress n=10 Participants Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage
Time to Uterine Contraction 1-2 minutes	1 Participants
Time to Uterine Contraction Less than 2 minutes	9 Participants

SECONDARY outcome

Timeframe: During the procedure

Time from insertion to removal of the device

Outcome measures

Outcome measures
Measure	InPress n=10 Participants Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage
Time	152 minutes Standard Deviation 111.7

Adverse Events

InPress

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	InPress n=10 participants at risk Treatment with InPress Device for Postpartum Hemorrhage InPress Device: Treatment with InPress Device for Postpartum Hemorrhage
Renal and urinary disorders urine retention post extraction with forceps with infected opened perineal laceration	10.0% 1/10 • Number of events 1

Additional Information

Jan Segnitz, MD

InPress Technologies Inc

Phone: (408) 238-9279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place