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

Conditions

• Shoulder Dystocia

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Yaari Extractor — DEVICE
  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 Details

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.

Key Dates

Start date

Nov 15, 2023

Status verified

Nov 2025

Primary completion

Nov 30, 2026

Completion

Apr 30, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Yaari Extractor group
  Prospective experimental arm
• No Intervention: Control group
  Historical control arm - retrospective review of medical records at the same study sites

Primary Outcome Measure

Number of successful neonate deliveries with the Yaari Extractor device [ Time Frame: immediately after the intervention ]

Central Contacts

• Ahava Stein
  +972522346927
  [email protected]

Locations (4)

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