Shoulder DystociaNCT05913609
Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
A study testing Yaari Extractor in people with Shoulder Dystocia, run by FetalEase Ltd. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dystocia
- What is being tested?
- Yaari Extractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Nov 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject 18 years of age or older at time of consent.
- Subject planning on vaginal birth.
- Singleton pregnancy in vertex presentation.
- Full-term pregnancy having completed 37 weeks or more gestational weeks.
- Able and willing to provide written informed consent prior to enrollment.
- In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF).
- 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."
Who cannot join
- Patients who have undergone attempted delivery using ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts ± suprapubic pressure with downward traction on the fetal head), prior to use of the Yaari Extractor. (NOTE: Hyperflexion of the hips or legs is allowed prior to and during use of the Yaari Extractor.)
- Cesarean section is planned for the patient.
- Obstetric contraindications to vaginal birth.
- Subject carrying fetus with known significant chromosomal or structural anomalies.
- Clinically estimated fetal weight ≥5kg in non-diabetic subjects.
- Clinically estimated fetal weight ≥4.5kg in subjects with diabetes.
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- 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.
- Bleeding disorders, such as thrombocytopenia, von Willebrand's disease, bleeding disorder currently using anticoagulation medication, etc.
- Any maternal disease or disorder that precludes the subject from pushing effectively.
- If the maternal cervix is not fully dilated.
- If the fetal head is not completely out of the birth canal.
- In the presence of a non-reducible nuchal cord.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Fatima Sahar, MBBS, 703-776-4600, Sahar.Fatima@inova.org
Scott A Sullivan, MD
- Recruiting
Rosemark WomenCare Specialist
Idaho Falls, Idaho, 83404
Nora Ramirez, 208-557-2924, nramirez@rosemark.net
Jason Gundersen, MD
- Recruiting
University of Miami - Jackson Memorial
Miami, Florida, 33136
Jemima Duroseau, BSN, RN, MPH, 305-689-8010, jxp431@med.miami.edu
Michael Paidas, MD
- Recruiting
Unified Women's Clinical Research
Winston-Salem, North Carolina, 27103
Nicole Cline, 336-955-8065 ext. 9718, nicole.cline@unifiedhc.com
Lisa Cumming, 3367909747 ext. 1009788, lisa.cumming@unifiedhc.com
About this study
Official title: 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.
- Conditions
- Shoulder Dystocia
- Being tested
- Yaari Extractor
- Medical subject headings
- Shoulder Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yaari ExtractorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Yaari Extractor group | Experimental | Prospective experimental arm Receives: Device: Yaari Extractor |
| Control group | No intervention | Historical control arm - retrospective review of medical records at the same study sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful neonate deliveries with the Yaari Extractor device
First Primary Effectiveness Endpoint
Measured: immediately after the intervention
Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery
Second Primary Effectiveness Endpoint
Measured: immediately after the intervention
Maternal and neonatal adverse events
Primary Safety Endpoint
Measured: through study completion, an average of 5 days
Secondary outcomes (1)
Ease of Use 5 point Likert scale User Questionnaire
Secondary Effectiveness Endpoint
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start15 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DystociaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FetalEase Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913609
- Sponsor's protocol ID
- CLT-005
- Status last verified
- Nov 2025
- First submitted
- 8 Jun 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDE Clinical Study to Evaluate the Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
- ClinicalTrials.gov ID
- NCT05913609
- Acronym / sponsor ID
- CLT-005
- Conditions
- Shoulder Dystocia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- FetalEase Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yaari Extractor group | Experimental | Device: Yaari ExtractorProspective experimental arm |
| Control group | No intervention | –Historical control arm - retrospective review of medical records at the same study sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject 18 years of age or older at time of consent.
- Subject planning on vaginal birth.
- Singleton pregnancy in vertex presentation.
- Full-term pregnancy having completed 37 weeks or more gestational weeks.
- Able and willing to provide written informed consent prior to enrollment.
Key exclusion criteria (12 listed)
- Patients who have undergone attempted delivery using ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts ± suprapubic pressure with downward traction on the fetal head), prior to use of the Yaari Extractor. (NOTE: Hyperflexion of the hips or legs is allowed prior to and during use of the Yaari Extractor.)
- Cesarean section is planned for the patient.
- Obstetric contraindications to vaginal birth.
- Subject carrying fetus with known significant chromosomal or structural anomalies.
- Clinically estimated fetal weight ≥5kg in non-diabetic subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yaari ExtractorThe 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. | Device | Yaari Extractor group |
Primary outcome
Number of successful neonate deliveries with the Yaari Extractor device
Time frame: immediately after the intervention
First Primary Effectiveness Endpoint
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
Maternal and neonatal adverse events
Time frame: through study completion, an average of 5 days
Primary Safety Endpoint
1 secondary outcome
Ease of Use 5 point Likert scale User Questionnaire
Time frame: immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yaari Extractor in people with Shoulder Dystocia, run by FetalEase Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahava Stein (+972522346927, ahava@asteinrac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful neonate deliveries with the Yaari Extractor device (time frame: immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.