Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids
- Conditions
- fibroid of the uterusmyoma10013326
- Registration Number
- NL-OMON39138
- Lead Sponsor
- Gynesonics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
(a) 28 years of age or older
(b) Consistent menstrual cycles between 22-35 days
(c) History of excessive bleeding for at least 3 months
(d) Baseline UFS-QOL SSS score >= 20
(e) At least one Target Fibroid having a maximum diameter > 5 cm and
<= 10 cm
(f) Total Target Fibroid Score <= 45
(g) Subject is not at material risk for pregnancy (not sexually active, does not have a male partner or is in a monogamous relationship with a sterilized male partner, using reliable oral or barrier contraception, intrauterine device (IUD) or the levonorgestrel intrauterine system (LNG-IUS) in accordance with the package insert). Subject is willing to maintain use or non-use of hormonal contraception uniformly from 3 months pre-study through the 12-month follow-up period. Only monthly cyclic combined contraceptive steroids will be acceptable as oral contraception.
(h) Willingness to participate in the study, to adhere to all study follow-up requirements, and to sign the informed consent form
(i) Subject is willing to have uniform maintenance (use or non-use) of any antifibrinolytic or nonsteroidal anti-inflammatory agents (COX inhibitors) for excessive vaginal bleeding for 2 months pre-study through the 12-month follow-up period
(j) Menstrual Pictogram score >= 120 during a one-month screening period.
(a) Presence of type 0 intracavitary fibroids
(b) Any Target Fibroid > 10 cm in maximum diameter
(c) Any abnormality of the endometrial cavity that, in the judgment of the investigator, obstructs access of the VizAblate Handpiece to the endometrial cavity.
(d) Postmenopausal by history
(e) Desire for current or future fertility
(f) Hemoglobin < 6 g/dl (3.7 mmol/L)
(g) Pregnancy, as determined by urine hCG obtained within 24 hours prior to VizAblate procedure
(h) Evidence of disorders of hemostasis
(i) 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 completion of screening UFS-QOL.
(j) Evidence for current cervical dysplasia (CIN II or greater)
(k) Endometrial hyperplasia
(l) Confirmed abdominal / pelvic malignancy within the previous five years
(m) Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease) or positive screening for pelvic gonorrhea or chlamydia
(n) Clinically significant adenomyosis
(o) Previous uterine artery embolization
(p) Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to completion of the screening UFS-QOL.
(q) Current use of anticoagulant therapy
(r) Need for emergency surgery to treat fibroid symptoms
(s) Major medical or psychiatric illness affecting general health or subject*s ability to adhere to the follow-up schedule or provide valid subject self-assessment data
(t) Contraindication to MRI, including allergy to contrast media or claustrophobia
(u) Renal insufficiency [serum creatinine >= 1.5 mg/dL (132.6 µmol/L)]]
(v) Uncontrolled hypertension lasting 2 years or more (systolic blood pressure >= 140 mm Hg and/or diastolic blood pressure >= 90 mm Hg that is not controlled with an antihypertensive drug regimen)
(w) One or more treatable fibroids that are calcified
(x) Chronic pelvic pain (disruptive for at least six months)
(y) Presence of an extrauterine pelvic mass
(z) Presence of a tubal implant for sterilization
(aa) Previous pelvic irradiation
(bb) Endometrial cavity length < 4.5 cm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>(a) Mean percentage change in target fibroid perfused volume</p><br>
- Secondary Outcome Measures
Name Time Method <p>(a) Safety (to include procedural safety and long-term safety, including<br /><br>specifically following subjects for the occurrence of pregnancy and pregnancy<br /><br>complications)<br /><br>(b) Percentage reduction in Symptom Severity Score (SSS) subscale of the<br /><br>Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) Questionnaire<br /><br>(c) Rate of surgical reintervention for menorrhagia<br /><br>(d) Mean return to normal activity (days)<br /><br>(e) Percentage reduction in Menstrual Pictogram score</p><br>