Status:
COMPLETED
DAISY Uterine Drain Device Evaluation
Lead Sponsor:
Raydiant Oximetry, Inc.
Conditions:
Cesarean Section Complications
Post Partum Hemorrhage
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this study is to obtain user feedback while placing and observing the DAISY uterine drain with wall suction. This study defines the obstetrical surgeons as "users" and the patients in whom...
Detailed Description
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. (D'Alton 2020). It is estimated that 14 million cases of PPH occur each year worldwide (Rath, 2011). In the United Sta...
Eligibility Criteria
Inclusion
- The participants consist of women undergoing planned CD for reasons unrelated to this study.
Exclusion
- Known intrauterine or cervical pathology that would interfere with device placement and/or use
- Ongoing intrauterine pregnancy
- Untreated uterine rupture
- Unresolved uterine inversion
- Current cervical cancer
- Current purulent infection of vagina, cervix, or uterus
- Retained products of conception
- Arterial bleeding requiring surgical or angiographic embolization
- Indication for hysterectomy
- Lack of study consent or unable to provide informed consent,
- Any condition (temporary or permanent) in which the investigator or user deems the patient unsuitable for the study procedures
Key Trial Info
Start Date :
May 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06219538
Start Date
May 22 2024
End Date
April 16 2025
Last Update
December 18 2025
Active Locations (1)
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1
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507