Status:
COMPLETED
Sonography Guided Transcervical Ablation of Uterine Fibroids
Lead Sponsor:
Gynesonics
Conditions:
Menorrhagia
Eligibility:
FEMALE
25-50 years
Phase:
NA
Brief Summary
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 Syst...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT02228174
Start Date
October 1 2014
End Date
November 1 2019
Last Update
February 11 2020
Active Locations (23)
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1
Kelly H. Roy M.D. P.C.
Phoenix, Arizona, United States, 85006
2
Advanced Women's Health Institute
Denver, Colorado, United States, 80246
3
Christiana Care Health Services, Inc.
Newark, Delaware, United States, 19718
4
George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037