Frontlight ResearchEarly access
TerminatedNo phase
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry
Key facts
- Who runs it
- Gynesonics
- Where
- Germany, Switzerland, and United Kingdom9 sites in 3 countriesChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 182 people enrolled
- Started
- 14 Jun 2017
- Ended
- 11 Nov 2024
- Type of study
- Observational
- Treatments tested
- Sonata System
- Record updated
- 16 December 2024
- Why it stopped
- Termination due to continued lack of patient compliance
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Have selected Sonata for treatment of symptomatic uterine fibroids or is participating in the OPEN study (Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids, NCT02844920, protocol # CL04897) or has completed participation in the OPEN study within the last 14 months
- Speaks and reads a language for which questionnaires are available
- Are greater than or equal to 18 years of age at the time of enrollment
- Willing and able to read, understand and sign the informed consent form, to participate in the registry and to adhere to all registry study follow-up requirements
Who cannot take part
- Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in the registry
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
SAGE is an observational post market registry with the objective of characterizing long term outcomes after treatment of uterine fibroids with the Sonata System in real world clinical practice settings.
The group in the trial
- Sonata
Women who undergo transcervical radiofrequency(RF) ablation with the Sonata System for treatment of their fibroids
Treatment: Sonata System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)
- Record updated
- 16 December 2024