Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA)

  • STATUS
    Recruiting
  • sponsor
    Gynesonics Inc.
Updated on 25 March 2021

Summary

Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA)

Description

If you’re tired of heavy periods due to uterine fibroids, you may qualify for a new clinical research study. The study is for the Sonata™ System – an investigational device that targets fibroids and preserves the uterus through an incision-free, outpatient procedure.

Unlike open surgery or laparoscopy, the Sonata System is designed to access the inside of the uterus without any incisions. The Sonata System uses sonography to locate and target the individual fibroids, and radiofrequency (heat) energy to treat the fibroids. Unlike hysterectomy, which removes the entire uterus, the Sonata System targets just the fibroids, thus preserving the uterus. This study will establish if the heat energy can make fibroids shrink and reduce fibroid-related symptoms.

Participants in the study will receive treatment and all study-related care at no cost. Following your treatment, you will be asked to meet with your study doctor up to 5 times over the next 12 months. These visits are an important part of the study, as they allow your doctor to closely monitor your results and overall experiences. You will receive a payment upon completion of many of these visits to compensate you for your time and travel.

Details
Condition Uterine Fibroids
Clinical Study IdentifierTX142955
SponsorGynesonics Inc.
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

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 ƒÊmol/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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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