Sonography Guided Transcervical Ablation of Uterine Fibroids
NCT ID: NCT02228174
Last Updated: 2020-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
147 participants
INTERVENTIONAL
2014-10-31
2019-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Subjects Treated with Sonata
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.
Intrauterine Ultrasound-Guided Radiofreq. Ablation 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).
Interventions
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Intrauterine Ultrasound-Guided Radiofreq. Ablation 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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 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
* 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
25 Years
50 Years
FEMALE
No
Sponsors
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Gynesonics
INDUSTRY
Responsible Party
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Locations
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Kelly H. Roy M.D. P.C.
Phoenix, Arizona, United States
Advanced Women's Health Institute
Denver, Colorado, United States
Christiana Care Health Services, Inc.
Newark, Delaware, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
KO Clinical Research, LLC
Fort Lauderdale, Florida, United States
Visions Clinical Research
Wellington, Florida, United States
The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates
Naperville, Illinois, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Wayne State University
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Mercy Clinic, Minimally Invasive Gynecology
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
Basque Women's Care
Albuquerque, New Mexico, United States
Montefiore Medical Center
New York, New York, United States
Carolina Women's Research and Wellness Center
Durham, North Carolina, United States
Drexel University
Philadelphia, Pennsylvania, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
Greenville Health System
Greenville, South Carolina, United States
Baylor Research Institute
Fort Worth, Texas, United States
Willowbend Health and Wellness Associates
Frisco, Texas, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León
Monterrey, N.L., Mexico
Countries
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References
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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.
Roy 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.
Shifrin 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.
Chudnoff 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CL04502
Identifier Type: -
Identifier Source: org_study_id
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