NCT05200117

Pregnolia System Intra-observer Variability

Intra-observer Variability in the Assessment of Cervical Stiffness With the Pregnolia System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Pregnolia AG · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

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

Timeline

• Start date: 2022-01-12
• Primary completion: 2023-12-17
• Completion: 2023-12-17
• First posted: 2022-01-20
• Last updated: 2024-03-29

Locations

1 site across 1 country: Switzerland