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Effectiveness and Safety Evaluation of Aqueduct -100 Device

NCT02851953 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-05-08

No results posted yet for this study

Summary

The purpose of the present clinical investigation is to collect data regarding the safety and effectiveness of the Aqueduct 100 device.

The effectiveness of the Aqueduct 100 will be determined by evaluating the ability to reach desired cervical dilation, and the time frame required to reach desired cervical dilation.

Conditions

  • Cervix Uteri Dilation

Interventions

DEVICE

Aqueduct-100

Sponsors & Collaborators

  • Sintesi Research Srl

    collaborator INDUSTRY

  • Aqueduct Medical Ltd

    lead INDUSTRY

Principal Investigators

  • Pierluigi Venturini, Professor · IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST

  • Simone Ferrero, Professor · IRCCS AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO IST

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • Italy

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 NCT02851953 on ClinicalTrials.gov