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Pregnolia System Intra-observer Variability

NCT05200117 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2024-03-29

No results posted yet for this study

Summary

The Pregnolia System is a CE-marked medical device assessing the mechanical stiffness of cervical tissue in women. The Pregnolia Probe has been engineered to minimize the influence of differences in handling and technique by the user.

This project aims to study intra-observer variability of the Pregnolia System in pregnant women in the clinical setting.

Furthermore, a same day repeated measurement serves to investigate the time period needed to recover the pre-measurement stiffness state due to viscoelasticity of the cervical tissue.

Conditions

  • Cervix; Pregnancy
  • Cervical Stiffness

Interventions

DEVICE

Pregnolia System

The cervical stiffness is measured with the Pregnolia System three times over a two-day period.

Sponsors & Collaborators

  • Pregnolia AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-12
Primary Completion
2023-12-17
Completion
2023-12-17

Countries

  • Switzerland

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 NCT05200117 on ClinicalTrials.gov