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NCT05913609 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
A NA study of Shoulder Dystocia, sponsored by FetalEase.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 4
- Study locations
NCT05913609 is a NA study of Shoulder Dystocia that is actively recruiting participants, run by FetalEase. The registered enrollment target is 80 participants. The trial reports 4 study locations across 4 states.
The verdict
NCT05913609, a NA study of Shoulder Dystocia, is actively recruiting participants, sponsored by FetalEase.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Yaari Extractor
Study Locations (4)
Florida
- University of Miami - Jackson Memorial - Miami
Idaho
- Rosemark WomenCare Specialist - Idaho Falls
North Carolina
- Unified Women's Clinical Research - Winston-Salem
Virginia
- Inova Fairfax Medical Campus - Falls Church
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-11-15 |
| Est. Completion | 2027-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05913609
The ClinicalTrials.gov registry entry for NCT05913609 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is FetalEase, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Shoulder Dystocia appearing as the primary indexed condition, and to 1 intervention - of which Yaari Extractor is the first listed.
NCT05913609 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, Idaho, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05913609 about?
NCT05913609 is a clinical study titled "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.
What is the current status of trial NCT05913609?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2023-11-15. Estimated completion is 2027-04.
What conditions does trial NCT05913609 study?
This clinical trial studies the following conditions: Shoulder Dystocia.
What interventions are being tested in trial NCT05913609?
The interventions under investigation include: Yaari Extractor (DEVICE).
Who is sponsoring clinical trial NCT05913609?
This trial is sponsored by FetalEase, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05913609 being conducted?
This trial has 4 study locations across Florida, Idaho, North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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