fibroid of the uterus myoma
Conditions
Interventions
Trans-cervical intrauterine-ultrasound-guided radiofrequency ablation.
Sponsors
Gynesonics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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 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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change in target fibroid perfused volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) Safety (to include procedural safety and long-term safety, including specifically following subjects for the occurrence of pregnancy and pregnancy complications) (b) Mean percentage reduction in Menstrual Pictogram score (Appendix A) (c) Mean percentage reduction in Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) Questionnaire (Appendix D) (d) Rate of surgical reintervention for menorrhagia (e) Mean return to normal activity (days) | — |
Countries
Netherlands
Outcome results
None listed