Uterine FibroidSAGENCT03118037
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry
An observational study of Uterine Fibroid, run by Gynesonics at 9 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroid
- What is being tested?
- Sonata System
- Type of treatment
- Medical device
- How many people
- 182 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 14 Jun 2017to 11 Nov 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who select to have their uterine fibroids treated with the Sonata System
Who may be able to join
- 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 join
- Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in the registry
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Germany6 sites
Evangelisches Krankenhaus Köln-Weyertal gemeinnützige GmbH
Cologne, 50931
Frauenklinik Universitätsklinikum Jena
Jena, 07743
Klinik für Frauenheilkunde und Geburtshilfe
Kempten, 87439
MarienKrankenhaus Schwerte Frauenklinik
Schwerte, 58239
Josephs-Hospital Warendorf
Warendorf, 48231
Marien Hospital Witten
Witten, 58452
United Kingdom2 sites
Addenbrookes Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Liverpool Women's NHS Foundation Trust
Liverpool, L8 7SS
About this study
Official title: Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)
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.
Read the detailed description
Patients whom have selected the CE-marked Sonata system for treatment of fibroids will be approached for study participation. Participation in the trial will consist of data collection in the form of questionnaires prior to and after the treatment at the following intervals: pre-procedure, 4 weeks, 1, 2, 3, 4 and 5 years following treatment.
The following data points will be collected: Length of stay, time to return to normal activities (Treatment Recovery Questionnaire), time to return to sexual activity (Treatment Recovery Questionnaire), change in fibroid symptom severity and quality of life (UFS-QOL), change in general health outcome (EQ-5D), work productivity and activity impairment (WPAI), subject satisfaction and overall treatment effect (Overall Treatment Effect and Satisfaction Questionnaire), pregnancy occurrence and outcome, non-medical re-intervention, adverse events related to the device/procedure.
Validated questionnaires are used where appropriate (UFS-QOL, E1-5D and WPAI). Double data entry will occur to ensure accurate capture of subject reported data. Monitoring will occur throughout the course of the trial to ensure adherence to the protocol.
As an observational trial, there are no pre-specified statistically powered endpoints.
- Conditions
- Uterine Fibroid
- Being tested
- Sonata System
- Keywords
- Radiofrequency Ablation
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonata SystemDevice
Also called Transcervical RF Ablation
Transcervical access for radiofrequency ablation of uterine fibroids
| Study group | Role | What they receive |
|---|---|---|
| Sonata | Women who undergo transcervical radiofrequency(RF) ablation with the Sonata System for treatment of their fibroids Receives: Device: Sonata System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pregnancy and Pregnancy Outcomes
Number of subjects with pregnancy and the number of pregnancies during the 5 year follow-up period. Outcome of each pregnancy including pregnancy outcomes, delivery route, antenatal and perinatal complications.
Measured: Up to 5 years-post procedure
Surgical Re-intervention for Heavy Menstrual Bleeding
Number of subjects who had surgical re-intervention to treat heavy menstrual bleeding during the 5 year follow-up period.
Measured: Up to 5 years-post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start14 Jun 2017
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Why it stopped: Termination due to continued lack of patient compliance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Gynesonics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118037
- Sponsor's protocol ID
- CL 04878
- Acronym
- SAGE
- Status last verified
- Dec 2024
- First submitted
- 27 Mar 2017
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Christoffel L, Romer T, Schiermeier S. Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results. Med Devices (Auckl). 2021 Mar 3;14:77-84. doi: 10.2147/MDER.S301166. eCollection 2021.
PubMed 33688276
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE)
- ClinicalTrials.gov ID
- NCT03118037
- Acronym / sponsor ID
- SAGE / CL 04878
- Conditions
- Uterine Fibroid
- Keywords
- Radiofrequency Ablation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Termination due to continued lack of patient compliance
- Enrolment
- 182 participants (actual)
- Lead sponsor
- GynesonicsIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients whom have selected the CE-marked Sonata system for treatment of fibroids will be approached for study participation. Participation in the trial will consist of data collection in the form of questionnaires prior to and after the treatment at the following intervals: pre-procedure, 4 weeks, 1, 2, 3, 4 and 5 years following treatment.
The following data points will be collected: Length of stay, time to return to normal activities (Treatment Recovery Questionnaire), time to return to sexual activity (Treatment Recovery Questionnaire), change in fibroid symptom severity and quality of life (UFS-QOL), change in general health outcome (EQ-5D), work productivity and activity impairment (WPAI), subject satisfaction and overall treatment effect (Overall Treatment Effect and Satisfaction Questionnaire), pregnancy occurrence and outcome, non-medical re-intervention, adverse events related to the device/procedure.
Validated questionnaires are used where appropriate (UFS-QOL, E1-5D and WPAI). Double data entry will occur to ensure accurate capture of subject reported data. Monitoring will occur throughout the course of the trial to ensure adherence to the protocol.
As an observational trial, there are no pre-specified statistically powered endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonata | – | Device: Sonata SystemWomen who undergo transcervical radiofrequency(RF) ablation with the Sonata System for treatment of their fibroids |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who select to have their uterine fibroids treated with the Sonata System
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonata SystemAlso: Transcervical RF AblationTranscervical access for radiofrequency ablation of uterine fibroids | Device | Sonata |
Primary outcome
Incidence of Pregnancy and Pregnancy Outcomes
Time frame: Up to 5 years-post procedure
Number of subjects with pregnancy and the number of pregnancies during the 5 year follow-up period. Outcome of each pregnancy including pregnancy outcomes, delivery route, antenatal and perinatal complications.
Surgical Re-intervention for Heavy Menstrual Bleeding
Time frame: Up to 5 years-post procedure
Number of subjects who had surgical re-intervention to treat heavy menstrual bleeding during the 5 year follow-up period.
Results and safety
The study was stopped early (reason given: Termination due to continued lack of patient compliance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 33688276Christoffel L, Romer T, Schiermeier S. Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results. Med Devices (Auckl). 2021 Mar 3;14:77-84. doi: 10.2147/MDER.S301166. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroid, run by Gynesonics at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, United Kingdom, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Termination due to continued lack of patient compliance). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pregnancy and Pregnancy Outcomes (time frame: Up to 5 years-post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.