Uterine FibroidsOPENNCT02844920
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
An observational study of Uterine Fibroids and Adhesions, run by Gynesonics at 6 sites in 4 countries.
Trial summary
This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids, Adhesions
- What is being tested?
- Intrauterine ultrasound guided radio-frequency ablation
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 20 Jul 2017to 27 Aug 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Individuals who desire treatment of intrauterine fibroids with RF ablation via the Sonata System.
Who may be able to join
- Have selected Sonata for treatment of fibroids in the presence of heavy menstrual bleeding
- Presence of at least one submucous myoma (type 1, type 2) or transmural fibroid (type 2-5)
- Willing and able to read, understand, and sign the informed consent form and to adhere to all study follow-up requirements
Who cannot join
- Preexisting adhesions within the endometrial cavity as indicated by an ESH score ≥ I as determined by the investigator
- One or more Type 0 fibroids and/or endometrial polyps of any size
- Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in this study
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany3 sites
Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg
Mannheim, 68167
Klinikum Oldenburg
Oldenburg
Universitätsklinikum Tübingen
Tübingen
Switzerland1 site
Universitätsklinik für Frauenheilkunde Inselspital Bern
Bern
About this study
This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.
Read the detailed description
Patients who agree to participate in this observational trial will have selected fibroid treatment with the Sonata System. Research participants will undergo hysteroscopy at 6 weeks following treatment to evaluate presence or absence of intrauterine adhesions.
Research participants will be asked to complete a quality of life questionnaire prior to and 6 weeks following treatment. Research participants will also complete a satisfaction survey and a diary that tracks their return to normal daily activities.
- Conditions
- Uterine Fibroids, Adhesions
- Being tested
- Intrauterine ultrasound guided radio-frequency ablation
- Medical subject headings
- Leiomyoma, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine ultrasound guided radio-frequency ablationDevice
Also called Sonata System
Radiofrequency ablation for the treatment of uterine fibroids
| Study group | Role | What they receive |
|---|---|---|
| Fibroid Treatment | Intrauterine ultrasound guided radio-frequency ablation Receives: Device: Intrauterine ultrasound guided radio-frequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids
Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos.
Measured: 6 weeks
Secondary outcomes (1)
Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated
As the risk of adhesion formation is higher when apposing fibroids are treated, this outcome measure assesses adhesiogenesis in the subgroup of the population who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start20 Jul 2017
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uterine FibroidsStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynesonics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844920
- Sponsor's protocol ID
- CL04897
- Acronym
- OPEN
- Status last verified
- Sep 2019
- First submitted
- 22 Jul 2016
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This observational study is intended to view the group as an entirety, individual participant data will be analyzed for adhesions but will not be shared independently.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
- ClinicalTrials.gov ID
- NCT02844920
- Acronym / sponsor ID
- OPEN / CL04897
- Conditions
- Uterine Fibroids, Adhesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- GynesonicsIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.
Detailed description
Patients who agree to participate in this observational trial will have selected fibroid treatment with the Sonata System. Research participants will undergo hysteroscopy at 6 weeks following treatment to evaluate presence or absence of intrauterine adhesions.
Research participants will be asked to complete a quality of life questionnaire prior to and 6 weeks following treatment. Research participants will also complete a satisfaction survey and a diary that tracks their return to normal daily activities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibroid Treatment | – | Device: Intrauterine ultrasound guided radio-frequency ablationIntrauterine ultrasound guided radio-frequency ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who desire treatment of intrauterine fibroids with RF ablation via the Sonata System.
Key inclusion criteria (3 listed)
- Have selected Sonata for treatment of fibroids in the presence of heavy menstrual bleeding
- Presence of at least one submucous myoma (type 1, type 2) or transmural fibroid (type 2-5)
- Willing and able to read, understand, and sign the informed consent form and to adhere to all study follow-up requirements
Key exclusion criteria (3 listed)
- Preexisting adhesions within the endometrial cavity as indicated by an ESH score ≥ I as determined by the investigator
- One or more Type 0 fibroids and/or endometrial polyps of any size
- Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in this study
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 |
|---|---|---|
| Intrauterine ultrasound guided radio-frequency ablationAlso: Sonata SystemRadiofrequency ablation for the treatment of uterine fibroids | Device | Fibroid Treatment |
Primary outcome
Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids
Time frame: 6 weeks
Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos.
1 secondary outcome
Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. This observational study is intended to view the group as an entirety, individual participant data will be analyzed for adhesions but will not be shared independently.
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Life Study: Lifestyle Intervention in Fibroid Elimination
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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.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids and Adhesions, run by Gynesonics at 6 sites in 4 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Netherlands, Switzerland, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 20 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2019.