Clinical trial NCT02228174: Sonography Guided Transcervical Ablation of Uterine Fibroids
Official title: Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Keywords: Abnormal Uterine Bleeding associated with fibroids
AUB-L
Fibroids
Heavy menstrual bleeding
HMB
Myoma
Menorrhagia
Lead sponsor: Gynesonics
Sponsor class: INDUSTRY
First posted: 2014-08-28
Enrollment: 147
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 System.

Eligibility criteria: 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

Primary outcomes:
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
measure: Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure
timeFrame: 12 Months
Secondary outcomes:
measure: Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)
timeFrame: Each Follow-up Visit through 24 Months
measure: Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months
timeFrame: Baseline and 12 Months
measure: 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
timeFrame: Baseline and 12 Months
measure: Time to Return to Normal Activity (RTNA) in Days
timeFrame: 30 Day post-procedure
measure: Overall Treatment Effect (OTE) at 12 Months
timeFrame: 12 Months
measure: Subject Satisfaction With Treatment at 12 Months
timeFrame: 12 Months
measure: Subject Willingness to Recommend Procedure at 12 Months
timeFrame: 12 Months
measure: Change in General Health State at 12 Months
timeFrame: Baseline and 12 Months
measure: Subject Pain
timeFrame: Immediately Post-procedure as well as Pre-discharge (Day 0)
measure: Procedure Tolerance
timeFrame: Post-procedure (Day 0)
measure: Mean Length of Stay
timeFrame: Day 0 - Day of Treatment
measure: Occurrence of Pregnancy
timeFrame: All Follow-up Visits through 24 Months
measure: Pregnancy Outcome - Gestation Age
timeFrame: 24 Months
measure: Pregnancy Outcome - Birth Weight
timeFrame: 24 Months
measure: Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months
timeFrame: Baseline and 12 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Kelly H. Roy M.D. P.C.
state: Arizona
city: Denver
country: United States
facility: Advanced Women's Health Institute
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Services, Inc.
state: Delaware
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: KO Clinical Research, LLC
state: Florida
city: Wellington
country: United States
facility: Visions Clinical Research
state: Florida
city: Naperville
country: United States
facility: The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Mercy Clinic, Minimally Invasive Gynecology
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: Basque Women's Care
state: New Mexico
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center
state: North Carolina
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Fort Worth
country: United States
facility: Baylor Research Institute
state: Texas
city: Frisco
country: United States
facility: Willowbend Health and Wellness Associates
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León
state: N.l.
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.