Sonography Guided Transcervical Ablation of Uterine Fibroids

NCT02228174 | Completed Results DMC

• 1 other identifier: CL04502
• Study Type: interventional
• Target: 147
• Locations: 2 countries
• Sites: 23

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.

Conditions

Menorrhagia

Keywords

Abnormal Uterine Bleeding associated with fibroids; AUB-L; Fibroids; Heavy menstrual bleeding; HMB; Myoma; Menorrhagia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 Months

Secondary Outcomes (15)

• Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)

  Each Follow-up Visit through 24 Months

• Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months

  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

  Baseline and 12 Months

• Time to Return to Normal Activity (RTNA) in Days

  30 Day post-procedure

• Overall Treatment Effect (OTE) at 12 Months

  12 Months

Study Arms (1)

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.

Device: Intrauterine Ultrasound-Guided Radiofreq. Ablation System

Interventions

Intrauterine Ultrasound-Guided Radiofreq. Ablation System DEVICE

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).

Also known as: Gynesonics Sonata System

Subjects Treated with Sonata

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynesonics: lead

Study Sites (23)

Kelly H. Roy M.D. P.C.

Phoenix, Arizona, 85006, United States

Location

Advanced Women's Health Institute

Denver, Colorado, 80246, United States

Location

Christiana Care Health Services, Inc.

Newark, Delaware, 19718, United States

Location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

KO Clinical Research, LLC

Fort Lauderdale, Florida, 33316, United States

Location

Visions Clinical Research

Wellington, Florida, 33414, United States

Location

The Advanced Gynecologic Surgery Institute - Charles E. Miller, MD & Associates

Naperville, Illinois, 60540, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Mercy Clinic, Minimally Invasive Gynecology

St Louis, Missouri, 63141, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Basque Women's Care

Albuquerque, New Mexico, 87109, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

Carolina Women's Research and Wellness Center

Durham, North Carolina, 27713, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Baylor Research Institute

Fort Worth, Texas, 76104, United States

Location

Willowbend Health and Wellness Associates

Frisco, Texas, 75035, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Hospital Universitario "Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León

Monterrey, N.L., 64460, Mexico

Location

Related Publications (4)

• 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.

  PMID: 35785107 DERIVED

• 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.

  PMID: 35497488 DERIVED

• 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.

  PMID: 33544889 DERIVED

• 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.

  PMID: 30531573 DERIVED

MeSH Terms

Conditions

Menorrhagia; Leiomyoma; Myoma

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Taraneh G. Farazi, Ph.D. (Vice President, Clinical Affairs)
• Organization: Gynesonics

tfarazi@gynesonics.com

650-216-3878

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 28, 2014
• Study Start: October 1, 2014
• Primary Completion: October 18, 2017
• Study Completion: November 1, 2019
• Last Updated: February 11, 2020
• Results First Posted: February 19, 2019

Record last verified: 2020-02

Locations

US (22); ME (1)