Leiomyoma, Menorrhagia, Uterine Fibroids
Conditions
Keywords
uterine fibroid RF ablation, intrauterine ultrasound, VizAblate
Brief summary
The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (\> 5 cm) symptomatic uterine fibroids.
Interventions
DEVICEVizAblate System
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy
Sponsors
Gynesonics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
28 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 28 years of age or older * Consistent menstrual cycles * History of excessive bleeding for at least 3 months * Baseline UFS-QOL Symptom severity score ≥ 20 * At least one target fibroid having a maximum diameter \> 5cm and ≤ 10 cm * Not at material risk for pregnancy * Willingness to participate, adhere to follow-up requirements, and sign the informed consent form * Willing to have uniform maintenance of antifibrinolytic or non steroidal anti-inflammatory agents * Menstrual Pictogram score ≥ 120 during a one-month screening period.
Exclusion criteria
* Presence of type 0 intracavitary fibroids * Target fibroid \> 10cm in maximum diameter * Abnormality of the endometrial cavity that obstructs access of the treatment device * Postmenopausal * Desire for current or future fertility * Hemoglobin \< 6 g/dl * Evidence of disorders of hemostasis * Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen, SERM or SPRM within the last 6 months prior to screening * Evidence for current cervical dysplasia (CIN II or greater) * Endometrial hyperplasia * Confirmed abdominal / pelvic malignancy within previous five years * Active pelvic infection or positive screen for pelvic gonorrhea or chlamydia * Clinically significant adenomyosis * Previous uterine artery embolization * Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to screening * Current use of anticoagulant therapy * Major medical or psychiatric illness affecting general health or ability to adhere to follow-up * Contraindication to MRI * Renal insufficiency * Uncontrolled hypertension lasting 2 years or more * Calcified fibroids * Presence of extrauterine pelvic mass * Presence of tubal implant for sterilization * Previous pelvic irradiation * Endometrial cavity length \< 4.5 cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change in target fibroid perfused volume | Baseline, 3 months, 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | Procedure through 12 mo | Procedure safety will be assessed by recording all adverse events that occur on the day of the procedure. Longer-term safety will be assessed by recording at each follow-up visit any untoward medical occurrence since baseline. Each adverse event will be assessed for severity and relationship to study device. |
| Percentage reduction in Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) Questionnaire | Baseline through 12 months | — |
| Rate of surgical reintervention for menorrhagia | through 12 months | — |
| Return to normal daily activity | 2 weeks or until returned to normal activity | — |
| Percentage reduction in Menstrual Pictogram score | through 12 months | — |
Countries
Mexico, Netherlands, United Kingdom
Outcome results
None listed