Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

July 3, 2024 updated by: FetalEase Ltd.

IDE Clinical Study to Evaluate the Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

Prospective, multi-center, single arm with historical control, to verify the safety and effectiveness of the Yaari Extractor used by board certified or board eligible U.S. OB/GYN physicians in the management of shoulder dystocia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami - Jackson Memorial
        • Contact:
        • Principal Investigator:
          • Michael Paidas, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Unified Women's Clinical Research
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert L Parker, MD
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Medical Campus
        • Contact:
        • Principal Investigator:
          • Scott A Sullivan, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subject 18 years of age or older at time of consent.
  2. Subject planning on vaginal birth.
  3. Singleton pregnancy in vertex presentation.
  4. Full-term pregnancy having completed 37 weeks or more gestational weeks.
  5. Able and willing to provide written informed consent prior to enrollment.
  6. In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF).
  7. Subject with fetus experiencing shoulder dystocia as defined by ACOG Practice Bulletin 178 "Shoulder dystocia is most commonly diagnosed as failure to deliver the fetal shoulder(s) with gentle downward traction on the fetal head, requiring additional maneuvers to effect delivery."

Exclusion Criteria:

  1. Patients who have undergone ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts/suprapubic pressure), prior to use of the Yaari Extractor.
  2. Cesarean section is planned for the patient.
  3. Obstetric contraindications to vaginal birth.
  4. Subject carrying fetus with known significant chromosomal or structural anomalies.
  5. Clinically estimated fetal weight ≥5kg in non-diabetic subjects.
  6. Clinically estimated fetal weight ≥4.5kg in subjects with diabetes.
  7. Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy.
  8. Bleeding disorders, such as thrombocytopenia, von Willebrand's disease, bleeding disorder currently using anticoagulation medication, etc.
  9. Any maternal disease or disorder that precludes the subject from pushing effectively.
  10. If the maternal cervix is not fully dilated.
  11. If the fetal head is not completely out of the birth canal.
  12. In the presence of a non-reducible nuchal cord.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yaari Extractor group
Prospective experimental arm
The Yaari Extractor device is a single-use prescription device for neonatal extraction in deliveries that are complicated by shoulder dystocia. The Study Device consists of two curved, rigid plastic-coated metal Arms with Handles which are used for control of the device outside the body, and an elastic Engagement Element which conforms to the maternal and neonatal anatomy, and which is used for direct contact with the entrapped neonate within the birth canal.
No Intervention: Control group
Historical control arm - retrospective review of medical records at the same study sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of successful neonate deliveries with the Yaari Extractor device
Time Frame: immediately after the intervention
First Primary Effectiveness Endpoint
immediately after the intervention
Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery
Time Frame: immediately after the intervention
Second Primary Effectiveness Endpoint
immediately after the intervention
Maternal and neonatal adverse events
Time Frame: through study completion, an average of 5 days
Primary Safety Endpoint
through study completion, an average of 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of Use 5 point Likert scale User Questionnaire
Time Frame: immediately after the intervention
Secondary Effectiveness Endpoint
immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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