RECRUITING

DAISY Uterine Drain Device Evaluation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

DAISY Uterine Drain: Device Evaluation With Standard Wall Suction

Quick Facts

Study Start:2024-05-22
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06219538

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The participants consist of women undergoing planned CD or D \& C for reasons unrelated to this study.
  1. * Known intrauterine or cervical pathology that would interfere with device placement and/or use
  2. * Ongoing intrauterine pregnancy
  3. * Untreated uterine rupture
  4. * Unresolved uterine inversion
  5. * Current cervical cancer
  6. * Current purulent infection of vagina, cervix, or uterus
  7. * Retained products of conception
  8. * Arterial bleeding requiring surgical or angiographic embolization
  9. * Indication for hysterectomy
  10. * Lack of study consent or unable to provide informed consent,
  11. * Plan for IUD placement after D \& C,
  12. * Any condition (temporary or permanent) in which the investigator or user deems the patient unsuitable for the study procedures

Contacts and Locations

Study Contact

Kristin Ayers, MPH
CONTACT
757.446.0529
ayerskl@evms.edu
Anna Przybylska
CONTACT
757-446-5121
przybya@evms.edu

Principal Investigator

Tetsuya Kawakita, MD
PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School

Study Locations (Sites)

Eastern Virginia Medical School
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Raydiant Oximetry, Inc.

  • Tetsuya Kawakita, MD, PRINCIPAL_INVESTIGATOR, Eastern Virginia Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-22
Study Completion Date2025-09

Study Record Updates

Study Start Date2024-05-22
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • uterine drain
  • PPH

Additional Relevant MeSH Terms

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