Leiomyoma, Menorrhagia, Uterine Fibroids
Conditions
Keywords
uterine fibroid RF ablation, intrauterine ultrasound, VizAblate
Brief summary
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating 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 * Regular, consistent menstrual cycles * History of excessive bleeding * One Menstrual Pictogram score ≥ 120 during a one-month screening period * Baseline Uterine Fibroid Symptom & Quality of Life (UFS-QOL) Symptom Severity Subscale (SSS) score ≥ 20 * Between 1 and 5 Target Fibroids between 1 cm and 5 cm and/or maximum volume 82.4cc * At least one fibroid must indent the endometrium * Subject is not at material risk for pregnancy. * Subject is willing to maintain use or non-use of hormonal contraception * Subject is willing to have uniform maintenance (use or non-use) of any antifibrinolytic or nonsteroidal anti-inflammatory agents
Exclusion criteria
* Subserosal fibroids with bulk symptoms * Presence of type 0 intracavitary fibroids * Any Target Fibroid \> 5 cm in maximum diameter with a volume \> 82.4cc * Any fibroid that obstructs access of the VizAblate probe * Postmenopausal by history * Desire for current or future fertility * Hemoglobin \< 6 g/dl * Pregnancy * Evidence of disorders of hemostasis * Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective progesterone receptor modulator (SPRM) * Short-term use of hormonal medication for management of bleeding * Evidence for current cervical dysplasia * Endometrial hyperplasia * Confirmed abdominal / pelvic malignancy within the previous five years * Active pelvic infection * Clinically significant adenomyosis * Previous uterine artery embolization. Previous surgical or ablative treatment for fibroids or menorrhagia within previous 12 months * Current use of anticoagulant therapy * Need for emergency surgery to treat fibroid symptoms * Concomitant intrauterine polyps \> 1.0 cm * Contraindication to MRI * Renal insufficiency * Uncontrolled hypertension lasting 2 years or more * One or more treatable fibroids that are calcified * Chronic pelvic pain * Presence of an extrauterine pelvic mass * Presence of a 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 | 3 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 Menstrual Pictogram score | baseline through 12 months | — |
| Percentage reduction in the Symptom Severity Subscale (SSS) 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 | — |
Other
| Measure | Time frame |
|---|---|
| Length of Stay | Day of procedure |
| Subject satisfaction | 3 month, 6 month, 12 months |
| Nonsurgical reintervention for menorrhagia | 30 day, 3 month, 6 month, 12 month |
| Anesthesia regimen | Day of procedure |
| System ease of use | End of study |
| Subject pain and tolerance of procedure | Day of procedure |
| HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire | 3 month, 6 month, 12 months |
| EuroQOL EQ-5D | 3 month, 6 month, 12 month |
Countries
Mexico, Netherlands, United Kingdom
Outcome results
None listed