Symptom Effectiveness Study of VizAblate* Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids (FAST-EU)

Completed

• Conditions: fibroid of the uterus; myoma; 10013364

• Registration Number: NL-OMON56811
• Lead Sponsor: Gynesonics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1) 28 years of age or older
2) Consistent menstrual cycles between 22-35 days that meet the following requirements for at least 4 of the last 6 menstrual cycles prior to enrollment:
(1) variations in cycle length of no more than +/- 3 days, and
(2) bleeding duration of 4-10 days
3) [Deleted]
4) History of excessive bleeding for at least 3 months as reported by the subject
5) One Menstrual Pictogram score >= 120 during a one-month screening period
6) Baseline UFS-QOL SSS score >= 20
7) Between 1 and 5 Target Fibroids that have a maximum diameter between 1 cm and 5 cm (and/or maximum volume 82.4 cc) as determined by transvaginal sonography and confirmed by MRI; the Target Fibroid count is exclusive of fibroids < 1.0 cm and any fibroids that are not Target Fibroids
8) At least one fibroid must indent the endometrium (discretely extending beyond the endometrial margin) as determined by infusion sonography and/or hysteroscopy and corroborated by contrast-enhanced MRI
9) Subject is not at material risk for pregnancy (not sexually active, does not have a male partner, sterilized or 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.
10) Willingness to participate in the study, to adhere to all study follow-up requirements, and to sign the informed consent form
11) 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

Exclusion Criteria

1) Subserosal fibroids with bulk symptoms as assessed by screening questionnaire
2) Presence of type 0 intracavitary fibroids
3) Any Target Fibroid > 5 cm in maximum diameter with a volume greater than 82.4 cc
4) Any fibroid that, in the judgment of the investigator, obstructs access of the VizAblate probe to the endometrial cavity. The Gynesonics Medical Director should be consulted in questionable cases and the correspondence documented in the study files.
5) Postmenopausal by history
6) Desire for current or future fertility
7) Hemoglobin < 6 g/dl
8) Pregnancy, as determined by urine hCG obtained within 24 hours prior to VizAblate procedure
9) Evidence of disorders of hemostasis as measured by structured questionnaire (see Appendix F). Note: Subject with a positive response to questions 2 or 3, but negative hematologic evaluation may be enrolled.
10) 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 initiation of screening Menstrual Pictogram history
11) [Deleted]
12) Short-term use of hormonal medication for management of bleeding
13) Evidence for current cervical dysplasia (CIN II or greater) based on testing (Pap smear, HPV testing and/or colposcopy and biopsy) within the past 12 months
14) Endometrial hyperplasia (including simple hyperplasia without atypia) as determined by an endometrial biopsy within 12 months prior to enrollment.
15) Confirmed abdominal / pelvic malignancy within the previous five years
16) Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease) or positive screening for pelvic gonorrhea or chlamydia
17) Clinically significant adenomyosis defined as more than 10% of the junctional zone measuring more than 10 mm in thickness as measured by MRI.
18) Previous uterine artery embolization.
Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to completion of the screening Menstrual Pictogram
19) Current use of anticoagulant therapy
20) Need for emergency surgery to treat fibroid symptoms
21) Concomitant intrauterine polyps > 1.0 cm or any that, in the opinion of the investigator, could contribute to abnormal uterine bleeding. If polyp removed, subject must be screened again to confirm persistence of symptoms for at least three (3) months post-resection.
22) 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
23) Contraindication to MRI, including allergy to contrast media or claustrophobia
24) Renal insufficiency [serum creatinine >= 1.5 mg/dL]
25) Uncontrolled hypertension lasting 2 years or more
26) [Deleted]
27) One or more treatable fibroids that are calcified (< 75% fibroid enhancement by volume on contrast-enhanced MRI)
28) Chronic pelvic pain
29) Presence of an extrauterine pelvic mass
30) Presence of a tubal implant for sterilization
31) Previous pelvic irradiation
32) Endometrial cavity length < 4.5 cm, as determined by transvaginal sonography or prior uterine sounding

Study & Design

• Study Type: Interventional
• Study Design: Not specified