SAGE study; Revision M
Research type
Research Study
Full title
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)
IRAS ID
278854
Contact name
Adel Soltan
Contact email
Sponsor organisation
Gynesonics, Inc.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
5 years, 9 months, 24 days
Research summary
The SAGE study is a post-market, prospective, multicenter, single-arm cohort registry set up to characterize long term outcomes after treatment with the Sonata System in real world clinical practice setting. Additionally, the study will obtain other data related to safety, subject satisfaction, and effectiveness.
The Sonata System is a CE-marked device to treat uterine fibroids and is used within its intended purpose in this study.
A patient is eligible for participation in this study only if the patient and physician have already selected the Sonata System for treatment of fibroids and the patient meets all the study eligibility criteria.
The study will enroll up to 500 subjects at up to 50 sites. Sites may be selected from any country in which the Sonata System has received marketing approval.
The study is expected to take up to 7.5 years from the first enrollment. Subjects will be followed postoperatively at 4 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months. This observational registry is designed to collect long term data following the standard treatment of fibroids with the Sonata System and is not intended to be statistically powered.REC name
Wales REC 7
REC reference
20/WA/0128
Date of REC Opinion
24 Apr 2020
REC opinion
Favourable Opinion