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Clinical Trial

EASE: The Materna Prep Pivotal Study

NCT: NCT03973281 · COMPLETED

NCT IDNCT03973281
StatusCOMPLETED
Start Date2019-12-11
Completion2026-07-30
SponsorMaterna Medical (INDUSTRY)
First posted
Last updated

Brief Summary

This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery. Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor. Subject participation in the study is targeted to be 12 months from the time of the use of the device during delivery.

Frequently Asked Questions

What is EASE: The Materna Prep Pivotal Study?

EASE: The Materna Prep Pivotal Study is a clinical trial registered under NCT03973281. Current status: COMPLETED.

What is the status of NCT03973281?

The current status of NCT03973281 (EASE: The Materna Prep Pivotal Study) is: COMPLETED.

When did EASE: The Materna Prep Pivotal Study start?

EASE: The Materna Prep Pivotal Study started on 2019-12-11.

Related Devices

K211959Milli Vaginal DilatorMaterna Medical K220035Milli Vaginal DilatorMaterna Medical K230767Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd. K241862Levina Pelvic Floor Muscle Stimulator (RS-48)Zmi Electronics , Ltd.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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