Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids with Radiofrequency Ablation under Integrated Intrauterine Sonography Guidance

Completed

Conditions: myoma
10013326
10029903
fibroid of the uterus

Registration Number: NL-OMON43153

Lead Sponsor: Gynesonics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1) Are premenopausal
2) Are * 25 and * 50 years of age at time of enrollment
3) Have experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least the previous three months as reported by the subject
4) Have * 1 and * 10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter * 1.0 cm and * 5.0 cm as determined by credentialed transvaginal sonography or magnetic resonance imaging (MRI). Fibroids of type 5, 6, and 7 do not count toward the clinically relevant total, irrespective of size.
5) Have at least one type 1, type 2, type 3, or type 2-5 fibroid.
6) Pictorial blood loss assessment chart (PBAC) score * 150 and * 500 during a single baseline cycle
7) Consistent menstrual cycles of between 22 to 35 days in duration that meet the following requirements for at least 4 of the last 6 menstrual cycles prior to enrollment as reported by the subject: (1) Variations in cycle length of no more than +/- 4 days, and (2) Bleeding duration of 3-10 days, in which the bleeding requires use of more than a pantiliner
8) Subject is not at material risk for pregnancy (not sexually active; has been sterilized; does not have a male partner or is in a monogamous relationship with a sterilized male partner; reliably uses barrier contraception, or oral or vaginal hormonal contraception. Subject is willing to maintain use or non-use of non-injectable hormonal contraception uniformly from 6 months pre-study through the 12-month follow-up period.1. If a subject is on oral/vaginal hormonal contraception solely for bleeding control, or if a subject does not wish to commit to 12 months of consistent hormonal contraceptive use, subject must discontinue use as per the washout period specified in Appendix H (protocol).
9) Speaks and reads a language for which validated questionnaires are available
10) 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

1) Pregnancy, as determined by urine or serum hCG obtained within 24 hours prior to treatment with Sonata
2) Urgent need for surgery to treat fibroid symptoms
3) Desire for current or future childbearing
4) Presence of a tubal implant for sterilization
5) Postmenopausal by history
6) Presence of type 0 fibroids, unless < 1 cm in diameter and are unlikely to contribute to bleeding in the judgment of the investigator.
7) Presence of a single polyp 1.5 cm, or multiple polyps of any size, within the uterine cavity, or excision of polyps within three months of completing any screening procedures
8) Any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter > 5.0 cm as determined by transvaginal sonography or magnetic resonance imaging (MRI)
9) Bulk symptoms (pelvic pressure, frequent urination) that significantly interfere with normal daily activities in the presence of one or more fibroids of FIGO type 5, type 6, or type 7
10) Exclusive presence of fibroids that, despite meeting other eligibility criteria, are insufficient to explain the severity of symptoms in the judgment of the Investigator
11) Presence of clinically relevant fibroids that cannot be treated for technical reasons (e.g. cervical fibroid)
12) Presence of an extrauterine pelvic mass that has not been diagnosed as benign
13) IUD/IUS in situ within the washout period specified in Appendix H (protocol) prior to undergoing any screening procedures
14) Not used
15) Previous procedure for fibroids or heavy menstrual bleeding other than myomectomy. Examples of excluded procedures: endometrial ablation, uterine artery/fibroid embolization, uterine artery occlusion, MR guided focused ultrasound, radiofrequency ablation.
16) Myomectomy by any route within 12 months prior to undergoing any screening procedures, or myomectomy > 12 months with less than 6 months of symptom relief
17) Any abnormality of the endometrial cavity that, in the judgment of the Investigator, obstructs access of the Sonata Handpiece to the endometrial cavity or fibroids (e.g., significant intrauterine synechiae)
18) Contraindication to MRI, including MR-incompatible implants, allergy to contrast media or claustrophobia, and weight that is above the limitation of the site-specific MRI scanner credentialed for the study
19) Total uterine volume * 1000 cc as determined by transvaginal sonography
20) Clinically significant adenomyosis based on sonography; presence confirmed by MRI (defined as more than 10% of the junctional zone measuring more than 10 mm in thickness as measured by MRI)
21) Confirmed or suspected diagnosis of clinically relevant endometriosis
22) One or more clinically relevant fibroids that are significantly calcified. If suspicion of calcification, refer to MRI. (Significant calcification is defined as being associated with a majority of the fibroid not showing enhancement on volume via contrast-enhanced MRI)
23) Previous pelvic irradiation
24) Not used
25) Renal insufficiency [serum creatinine * 1.5 mg/dL (132.6 *mol/L)]
26) Evidence of disorders of hemostasis (AUB-C) as assessed through structured interview and confirmed by hematologic evaluation consistent with a coagulopathy (see Appendix D)
27) Abnormal cervical cytology that is unevaluated or untreated in adherence with national guidelines
28) Endometrial hyperplasia (AUB-M), including simple hyperplasia without at

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>(a) Reduction in menstrual blood loss (MBL) as assessed by pictorial blood loss<br /><br>assessment chart (PBAC)<br /><br>(b) Rate of surgical reintervention for heavy menstrual bleeding (HMB) due to<br /><br>treatment failure</p><br>

Secondary Outcome Measures