DAISY Uterine Drain Device Evaluation

NCT06219538 | Completed Results FDA Device

• 1 other identifier: CP2400
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

uterine drain; PPH

Outcome Measures

Primary Outcomes (1)

• Device Evaluation

  This is a prospective, single-arm, device evaluation study of device use by five (5) obstetrical surgeons placing the drain with low-level suction in up to ten (10) women undergoing elective, non-emergent cesarean delivery. Hemoglobin was measured at two time points: baseline (preoperative) and 1 day post operative. The mean change in hemoglobin concentration between baseline (preoperative) values obtained on the day of surgery and postoperative day 1 was analyzed and compared to historical means in the US in 31 hospitals with 5470 participants.

  Day of surgery (preoperative) and one day post procedure

Study Arms (1)

Interventional

EXPERIMENTAL

Ten women in whom the Daisy Drain is placed.

Device: DAISY Uterine Drain

Interventions

DAISY Uterine Drain DEVICE

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

Interventional

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only adult women over the age of eighteen can be included.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants consist of women undergoing planned CD for reasons unrelated to this study.

You may not qualify if:

• 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,
• Any condition (temporary or permanent) in which the investigator or user deems the patient unsuitable for the study procedures

Sponsors & Collaborators

• Raydiant Oximetry, Inc.: lead

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Kawakita T, Ray N, Brennan M, Rosen M, Saade G. A Uterine Suction Device to Prevent Postpartum Hemorrhage in Scheduled Cesarean Delivery: A Pilot Study. Am J Perinatol. 2025 Dec 4. doi: 10.1055/a-2752-8798. Online ahead of print.

  PMID: 41285413 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases

Limitations and Caveats

Small sample size, single-site setting, reliance on historical controls; perioperative fluid shifts may confound hemoglobin-based blood-loss estimates.

Results Point of Contact

• Title: Tetsuya Kawakita, MD
• Organization: Eastern Virginia Medical School at Old Dominion University

kawakit@odu.edu

757-446-7900

Study Officials

• Tetsuya Kawakita, MD

  Eastern Virginia Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The participants consist of women undergoing planned CD for reasons unrelated to this study.

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 23, 2024
• Study Start: May 22, 2024
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)