20 Participants Needed

DAISY Uterine Drain for Postpartum Hemorrhage

KA
AP
Overseen ByAnna Przybylska
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Raydiant Oximetry, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 the drain is placed as "participants." Participants are pregnant women who are undergoing cesarean delivery (CD) or D \& C, who have not entered active labor, who have consented to drain placement and who have met all the inclusion/exclusion criteria. Users are staff or fellow obstetrical surgeons who will use the drain and provide the evaluation.

Who Is on the Research Team?

TK

Tetsuya Kawakita, MD

Principal Investigator

Eastern Virginia Medical School

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Women who are having a planned cesarean delivery for reasons not related to this study are not eligible to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Placement of the DAISY uterine drain during cesarean delivery or D & C, followed by continuous suction for at least two hours post-surgery

Immediate post-procedure
1 visit (in-person)

Follow-up

Evaluation of uterine tone and device placement using manual palpation and abdominal ultrasound

2 hours post-surgery
1 visit (in-person)

Device Evaluation

Obstetrical surgeons complete a questionnaire evaluating the DAISY drain's ease of use and effectiveness

Immediately post-procedure

What Are the Treatments Tested in This Trial?

Interventions

  • DAISY Uterine Drain
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: InterventionalExperimental Treatment1 Intervention
Twenty women in whom the Daisy Drain is placed.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Raydiant Oximetry, Inc.

Lead Sponsor

Trials
6
Recruited
110+
Unbiased ResultsWe believe in providing patients with all the options.
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