DAISY Uterine Drain Device Evaluation

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

DAISY Uterine Drain: Device Evaluation With Standard Wall Suction

DAISY Uterine Drain Device Evaluation

Condition
Cesarean Section Complications
Intervention / Treatment

-

Contacts and Locations

Norfolk

Eastern Virginia Medical School, Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * The participants consist of women undergoing planned CD or D \& C for reasons unrelated to this study.
  • * 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,
  • * Plan for IUD placement after D \& C,
  • * Any condition (temporary or permanent) in which the investigator or user deems the patient unsuitable for the study procedures

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Raydiant Oximetry, Inc.,

Tetsuya Kawakita, MD, PRINCIPAL_INVESTIGATOR, Eastern Virginia Medical School

Study Record Dates

2025-09