MenorrhagiaSONATANCT02228174
Sonography Guided Transcervical Ablation of Uterine Fibroids
A study testing Intrauterine Ultrasound-Guided Radiofreq. Ablation System in people with Menorrhagia, run by Gynesonics at 23 sites in 2 countries.
Trial summary
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Intrauterine Ultrasound-Guided Radiofreq. Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Oct 2014to Nov 2019
- Phase
- Interventional
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- premenopausal
- ≥ 25 and ≤ 50 years of age at time of enrollment
- experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least 3 months
- between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter ≥ 1.0 cm and ≤ 5.0 cm
- at least one type 1, type 2, type 3, or type 2-5 fibroid.
- PBAC score ≥ 150 and ≤ 500
Show all 10Show fewer
- consistent menstrual cycles
- not at material risk for pregnancy
- speaks and reads a language for which validated questionnaires are available
- willing and able to read, understand, and sign the informed consent form, to participate in the study and to adhere to all study follow-up requirements
Who cannot join
- pregnancy
- urgent need for surgery to treat fibroid symptoms
- desire for current or future childbearing
- presence of a tubal implant for sterilization
- postmenopausal by history
- presence of type 0 fibroids, unless < 1 cm in diameter
Show all 36Show fewer
- presence of a single polyp ≥ 1.5 cm, or multiple polyps of any size
- any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter > 5.0 cm
- bulk symptoms in the presence of one or more fibroids of FIGO type 5, type 6, or type 7
- exclusive presence of fibroids that are insufficient to explain the severity of symptoms
- presence of clinically relevant fibroids that cannot be treated for technical reasons
- presence of an extrauterine pelvic mass that has not been diagnosed as benign
- IUD/IUS in situ within the washout period
- previous procedure for fibroids or heavy menstrual bleeding other than myomectomy
- myomectomy within 12 months
- any abnormality of the endometrial cavity that obstructs access of the handpiece
- contraindication to MRI
- total uterine volume > 1000 cc
- clinically significant adenomyosis
- confirmed or suspected diagnosis of clinically relevant endometriosis
- one or more clinically relevant fibroids that are significantly calcified.
- previous pelvic irradiation
- renal insufficiency [serum creatinine ≥ 1.5 mg/dL (132.6 μmol/L)]
- evidence of disorders of hemostasis (AUB-C)
- abnormal cervical cytology that is unevaluated or untreated in adherence with national guidelines
- endometrial hyperplasia (AUB-M), including simple hyperplasia without atypia
- confirmed abdominal / pelvic malignancy within the previous five years
- active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia;
- use of a hormonally-relevant medication within the washout period
- use of an antifibrinolytic agent while undergoing any screening procedures
- current use of anticoagulant therapy
- chronic pelvic pain (disruptive for at least six months) or significant baseline pelvic or menstrual pain
- chronic uncontrolled moderate and severe hypertension
- hypoplastic or otherwise short uterus
- major medical or psychiatric illness or other factors that may affect general health or subject's ability to adhere to the follow-up schedule or provide valid subject self-assessment data
- any other reason for which the individual study subject is not appropriate or suitable for participation
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
Basque Women's Care
Albuquerque, New Mexico, 87109
University of Maryland Medical Center
Baltimore, Maryland, 21201
Cooper University Hospital
Camden, New Jersey, 08103
Advanced Women's Health Institute
Denver, Colorado, 80246
Wayne State University
Detroit, Michigan, 48201
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713
KO Clinical Research, LLC
Fort Lauderdale, Florida, 33316
Baylor Research Institute
Fort Worth, Texas, 76104
Willowbend Health and Wellness Associates
Frisco, Texas, 75035
Greenville Health System
Greenville, South Carolina, 29605
University of Mississippi Medical Center
Jackson, Mississippi, 39216
The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates
Naperville, Illinois, 60540
Montefiore Medical Center
New York, New York, 10467
Christiana Care Health Services, Inc.
Newark, Delaware, 19718
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Drexel University
Philadelphia, Pennsylvania, 19104
Kelly H. Roy M.D. P.C.
Phoenix, Arizona, 85006
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Virginia Mason Medical Center
Seattle, Washington, 98101
Mercy Clinic, Minimally Invasive Gynecology
St Louis, Missouri, 63141
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Visions Clinical Research
Wellington, Florida, 33414
Mexico1 site
Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León
Monterrey, N.L., 64460
About this study
Official title: Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
Read the detailed description
In this single-arm study, subjects who have symptomatic uterine fibroids will have transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using the Gynesonics Sonata System.
- Conditions
- Menorrhagia
- Being tested
- Intrauterine Ultrasound-Guided Radiofreq. Ablation System
- Keywords
- Abnormal Uterine Bleeding associated with fibroids, AUB-L, Fibroids, Heavy menstrual bleeding, HMB, Myoma, Menorrhagia
- Medical subject headings
- Menorrhagia, Leiomyoma, Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine Ultrasound-Guided Radiofreq. Ablation SystemDevice
Also called Gynesonics Sonata System
The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting, and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding(HMB).
| Study group | Role | What they receive |
|---|---|---|
| Subjects Treated with Sonata | Experimental | Intervention: Intrauterine Ultrasound-Guided Radiofreq. Ablation System or the Sonata, which is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with Sonata. Receives: Device: Intrauterine Ultrasound-Guided Radiofreq. Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)
The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score < 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a "scale". PBAC ≥ 150 is associated with heavy menstrual bleeding.
Measured: Baseline and 12 Months
Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure
This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was "no surgical reintervention for HMB due to treatment failure at 12 months", the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method.
Measured: 12 Months
Secondary outcomes (15)
Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)
Procedure safety was assessed by recording all adverse device effects that occured during or subsequent to treatment on the day of the procedure. Longer-term safety was assessed by recording any untoward medical occurrence since baseline at each follow-up visit.
Measured: Each Follow-up Visit through 24 Months
Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months
The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months.
Measured: Baseline and 12 Months
Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months
The Symptom Severity Score (SSS) and Health-Related Quality of Life Score (HR-QoL) are calculated from a subset of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire, a validated and fibroid-specific assessment tool. The UFS-QoL is a uterine fibroid-specific questionnaire developed to evaluate the symptoms of uterine fibroids and their impact on quality of life related to health. SSS and HR-QoL subscale scores are summed and transformed into a 0-100 point scale. The SSS and HR-QoL subscale scores are inversely related with higher SSS indicating greater symptoms while higher HR-QoL scores indicate better quality of life.
Measured: Baseline and 12 Months
Time to Return to Normal Activity (RTNA) in Days
Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.
Measured: 30 Day post-procedure
Overall Treatment Effect (OTE) at 12 Months
The Overall Treatment Effect is a questionnaire for subjects to report their perceived treatment benefit at a given timepoint as either improved, no change, or worsened.
Measured: 12 Months
Subject Satisfaction With Treatment at 12 Months
Subjects were asked to rate their level of satisfaction with the treatment. The possible ratings were as follows: "very satisfied", "moderately satisfied", "somewhat satisfied", "somewhat dissatisfied", "moderately dissatisfied", and "very dissatisfied".
Measured: 12 Months
Subject Willingness to Recommend Procedure at 12 Months
Subjects were asked whether they would recommend the procedure to a friend with the same health problems. The possible responses were: "definitely yes", "probably yes", "probably no", and "definitely no".
Measured: 12 Months
Change in General Health State at 12 Months
Change in general health state was assessed with the EuroQOL EQ-5D. The EQ-5D is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, EuroQOL EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of five questions that provide a description of the patient's health state with scores ranging from 0 (indicating death) to 1 (indicating perfect health). An increase of 0.04 in EQ-5D is considered by health economists to represent a minimally important difference.
Measured: Baseline and 12 Months
Subject Pain
Prior to discharge, subjects were asked to rate their experience of pain using a pain Visual Analog Scale (VAS). The VAS for pain is a measurement instrument by which subjects report the intensity of their pain with a quantitative value from 0 (no pain) to 10 (worst pain ever).
Measured: Immediately Post-procedure as well as Pre-discharge (Day 0)
Procedure Tolerance
Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were "very tolerable", "moderately tolerable", "minimally tolerable", "intolerable".
Measured: Post-procedure (Day 0)
Mean Length of Stay
Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.
Measured: Day 0 - Day of Treatment
Occurrence of Pregnancy
Subjects were asked about the possible occurrence of pregnancy.
Measured: All Follow-up Visits through 24 Months
Pregnancy Outcome - Gestation Age
If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.
Measured: 24 Months
Pregnancy Outcome - Birth Weight
If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.
Measured: 24 Months
Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months
The Work Productivity and Activity Impairment questionnaire for a specific health problem (WPAI:SHP) is a standardized instrument for making a quantitative assessment of work impairment and activity impairment attributable to a specific health problem (WPAI:SHP). The assessments are expressed in percentages. The endpoint assessed the difference in these percentages from baseline to 12 months.
Measured: Baseline and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startOct 2014
- Primary completion18 Oct 2017
- Study completionNov 2019
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynesonics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228174
- Sponsor's protocol ID
- CL04502
- Acronym
- SONATA
- Status last verified
- Feb 2020
- First submitted
- 25 Aug 2014
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Christoffel L, Bends R, Toub D, Schiermeier S, Pschadka G, Engelhardt M, Quinn S, Hartmann M, Habiba M, Felberbaum R, Brossner A, Schippert C, Romer T. Pregnancy Outcomes After Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System. J Gynecol Surg. 2022 Jun 1;38(3):207-213. doi: 10.1089/gyn.2021.0136. Epub 2022 Jun 13.
PubMed 35785107Roy K, Robinson JK. Durable Improvement in Generic and Fibroid-Specific Quality of Life in Women Treated with Transcervical Fibroid Ablation with the Sonata System After Three Years. J Gynecol Surg. 2022 Apr 1;38(2):143-147. doi: 10.1089/gyn.2021.0073. Epub 2022 Apr 1.
PubMed 35497488Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021 Oct;155(1):79-85. doi: 10.1002/ijgo.13638. Epub 2021 Mar 17.
PubMed 33544889Chudnoff S, Guido R, Roy K, Levine D, Mihalov L, Garza-Leal JG. Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas. Obstet Gynecol. 2019 Jan;133(1):13-22. doi: 10.1097/AOG.0000000000003032.
PubMed 30531573
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance
- ClinicalTrials.gov ID
- NCT02228174
- Acronym / sponsor ID
- SONATA / CL04502
- Conditions
- Menorrhagia
- Keywords
- Abnormal Uterine Bleeding associated with fibroids, AUB-L, Fibroids, Heavy menstrual bleeding, HMB, Myoma, Menorrhagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- GynesonicsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
Detailed description
In this single-arm study, subjects who have symptomatic uterine fibroids will have transcervical RF ablation of uterine fibroids under intrauterine ultrasound guidance using the Gynesonics Sonata System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects Treated with Sonata | Experimental | Device: Intrauterine Ultrasound-Guided Radiofreq. Ablation SystemIntervention: Intrauterine Ultrasound-Guided Radiofreq. Ablation System or the Sonata, which is a sonography guided transcervical ablation device intended for treatment of symptomatic uterine fibroids. Subjects with symptomatic uterine fibroids and heavy menstrual bleeding who met the study population selection criteria received treatment with Sonata. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- premenopausal
- ≥ 25 and ≤ 50 years of age at time of enrollment
- experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least 3 months
- between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter ≥ 1.0 cm and ≤ 5.0 cm
- at least one type 1, type 2, type 3, or type 2-5 fibroid.
Key exclusion criteria (36 listed)
- pregnancy
- urgent need for surgery to treat fibroid symptoms
- desire for current or future childbearing
- presence of a tubal implant for sterilization
- postmenopausal by history
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 Radiofreq. Ablation SystemAlso: Gynesonics Sonata SystemThe Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting, and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding(HMB). | Device | Subjects Treated with Sonata |
Primary outcome
Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)
Time frame: Baseline and 12 Months
The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score < 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a "scale". PBAC ≥ 150 is associated with heavy menstrual bleeding.
Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure
Time frame: 12 Months
This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was "no surgical reintervention for HMB due to treatment failure at 12 months", the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method.
15 secondary outcomes
Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)
Time frame: Each Follow-up Visit through 24 Months
Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months
Time frame: Baseline and 12 Months
Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months
Time frame: Baseline and 12 Months
Time to Return to Normal Activity (RTNA) in Days
Time frame: 30 Day post-procedure
Overall Treatment Effect (OTE) at 12 Months
Time frame: 12 Months
Subject Satisfaction With Treatment at 12 Months
Time frame: 12 Months
Subject Willingness to Recommend Procedure at 12 Months
Time frame: 12 Months
Change in General Health State at 12 Months
Time frame: Baseline and 12 Months
Subject Pain
Time frame: Immediately Post-procedure as well as Pre-discharge (Day 0)
Procedure Tolerance
Time frame: Post-procedure (Day 0)
Mean Length of Stay
Time frame: Day 0 - Day of Treatment
Occurrence of Pregnancy
Time frame: All Follow-up Visits through 24 Months
Pregnancy Outcome - Gestation Age
Time frame: 24 Months
Pregnancy Outcome - Birth Weight
Time frame: 24 Months
Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months
Time frame: Baseline and 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35785107Christoffel L, Bends R, Toub D, Schiermeier S, Pschadka G, Engelhardt M, Quinn S, Hartmann M, Habiba M, Felberbaum R, Brossner A, Schippert C, Romer T. Pregnancy Outcomes After Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System. J Gynecol Surg. 2022 Jun 1;38(3):207-213. doi: 10.1089/gyn.2021.0136. Epub 2022 Jun 13.
- Derived from this study: PubMed 35497488Roy K, Robinson JK. Durable Improvement in Generic and Fibroid-Specific Quality of Life in Women Treated with Transcervical Fibroid Ablation with the Sonata System After Three Years. J Gynecol Surg. 2022 Apr 1;38(2):143-147. doi: 10.1089/gyn.2021.0073. Epub 2022 Apr 1.
- Derived from this study: PubMed 33544889Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021 Oct;155(1):79-85. doi: 10.1002/ijgo.13638. Epub 2021 Mar 17.
- Derived from this study: PubMed 30531573Chudnoff S, Guido R, Roy K, Levine D, Mihalov L, Garza-Leal JG. Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas. Obstet Gynecol. 2019 Jan;133(1):13-22. doi: 10.1097/AOG.0000000000003032.
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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.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine Ultrasound-Guided Radiofreq. Ablation System in people with Menorrhagia, run by Gynesonics at 23 sites in 2 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 10 inclusion and 36 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Mexico. 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 19 Feb 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?
Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC) (time frame: Baseline and 12 Months). 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 NCT02228174, which also lists 4 linked publications.
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 11 Feb 2020.