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A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth

NCT06698185 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-20

No results posted yet for this study

Summary

This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device. The device will be used during the first stage of labor, following initiation of epidural anesthesia and after the cervix has dilated to between 3-8 cm. Up to 20 subjects will be included in the initial study, with the option to increase the number of subjects to 50 based on early data.

Conditions

  • Childbirth

Interventions

DEVICE

Materna Prep Device

Materna Prep Device

DEVICE

Sham Control

Sham Control

Sponsors & Collaborators

  • El Camino Hospital, Mountain View, CA

    collaborator UNKNOWN

  • Altos Oaks Medical Group, Mountain View, CA

    collaborator UNKNOWN

  • Materna Medical

    lead INDUSTRY

Principal Investigators

  • Kenneth Weber, MD · Obstatrician, Altos Oaks Medical Group

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06698185 on ClinicalTrials.gov