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DAISY Uterine Drain Device Evaluation

NCT06219538 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-01

Study results available
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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 the drain is placed as "participants." Participants are pregnant women who are undergoing cesarean delivery (CD), 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.

Conditions

  • Cesarean Section Complications
  • Post Partum Hemorrhage
  • Uterine Atony With Hemorrhage
  • Uterine Bleeding

Interventions

DEVICE

DAISY Uterine Drain

Insertion of the DAISY Uterine Drain and connection to wall suction in women who have undergone a Caesarean Delivery,

Sponsors & Collaborators

  • Raydiant Oximetry, Inc.

    lead INDUSTRY

Principal Investigators

  • Tetsuya Kawakita, MD · Eastern Virginia Medical School

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-22
Primary Completion
2025-04-16
Completion
2025-04-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06219538 on ClinicalTrials.gov