RECRUITING

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

Conditions

Quick Navigation

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

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.

Official Title

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

Quick Facts

Study Start:2023-11-15

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05913609

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 Criteria	Exclusion 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."	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.

Inclusion Criteria

Exclusion 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."

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.

Contacts and Locations

Study Contact

Ahava Stein

CONTACT

+972522346927

ahava@asteinrac.com

Study Locations (Sites)

University of Miami - Jackson Memorial

Miami, Florida, 33136

United States

Unified Women's Clinical Research

Winston-Salem, North Carolina, 27103

United States

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042

United States

Collaborators and Investigators

Sponsor: FetalEase Ltd.

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 Date2023-11-15

Study Completion Date2026-04

Study Record Updates

Study Start Date2023-11-15

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Shoulder Dystocia