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DAISY Uterine Drain for Postpartum Hemorrhage

N/A
Recruiting
Led By Tetsuya Kawakita, MD
Research Sponsored by Raydiant Oximetry, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* The participants consist of women undergoing planned CD for reasons unrelated to this study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post caesarean delivery (cd)
Awards & highlights

Summary

This trial aims to gather feedback on using the DAISY uterine drain with wall suction. Obstetrical surgeons will be the users, and pregnant women undergoing cesarean delivery will be the

Who is the study for?
This trial is for pregnant women scheduled for a cesarean delivery (C-section) who haven't started active labor. They must consent to having the DAISY Uterine Drain placed during surgery and meet all other study requirements.
What is being tested?
The DAISy Uterine Drain device is being evaluated in this study. Obstetrical surgeons, considered 'users', will place the drain in participants during C-sections and provide feedback on its use and effectiveness.
What are the potential side effects?
Potential side effects are not explicitly listed, but may include discomfort or complications related to the placement of the uterine drain device during a cesarean section.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post caesarean delivery (cd)
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post caesarean delivery (cd) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device evaluation

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionalExperimental Treatment1 Intervention
Ten women in whom the Daisy Drain is placed.

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Who is running the clinical trial?

Raydiant Oximetry, Inc.Lead Sponsor
5 Previous Clinical Trials
81 Total Patients Enrolled
Tetsuya Kawakita, MDPrincipal InvestigatorEastern Virginia Medical School
2 Previous Clinical Trials
300 Total Patients Enrolled
~2 spots leftby Nov 2024
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