Clinical trial · Interventional
Sonography Guided Transcervical Ablation of Uterine Fibroids
Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance
NCT02228174CI-TRIAL-00043316SONATAcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Menorrhagia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrauterine Ultrasound-Guided Radiofreq. Ablation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Subjects Treated with Sonata
- description
- 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.
- interventionNames
- Device: Intrauterine Ultrasound-Guided Radiofreq. Ablation System
Primary outcomes (2)
- measure
- Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)
- timeFrame
- Baseline and 12 Months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
References
Publications (4)
- DERIVEDChristoffel 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. PMID 35785107
- DERIVEDRoy 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. PMID 35497488
- DERIVEDShifrin 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. PMID 33544889
- DERIVEDChudnoff 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. PMID 30531573