Clinical trial NCT01539187: Fibroid Ablation Study - Large Fibroids
Official title: Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Leiomyoma
Uterine Fibroids
Menorrhagia
Keywords: uterine fibroid RF ablation
intrauterine ultrasound
VizAblate
Lead sponsor: Gynesonics
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 6
Sex: FEMALE
Minimum age (years): 28
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean percentage change in target fibroid perfused volume
timeFrame: Baseline, 3 months, 12 months
Secondary outcomes:
measure: Number of adverse events
timeFrame: Procedure through 12 mo
measure: Percentage reduction in Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) Questionnaire
timeFrame: Baseline through 12 months
measure: Rate of surgical reintervention for menorrhagia
timeFrame: through 12 months
measure: Return to normal daily activity
timeFrame: 2 weeks or until returned to normal activity
measure: Percentage reduction in Menstrual Pictogram score
timeFrame: through 12 months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon (UANL)
state: Nuevo Leon
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
state: North Holland
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
city: Whitechapel
country: United Kingdom
facility: Royal London Hospital
state: London
city: Birmingham
country: United Kingdom
facility: Birmingham Women's NHS Foundation Trust
state: West Midlands
city: Haywards Heath
country: United Kingdom
facility: Princess Royal Hospital
state: West Sussex
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Trust
state: West Yorkshire
city: London
country: United Kingdom
facility: University College Hospital
Study officials:
affiliation: Gynesonics
name: David Toub, MD
role: STUDY_DIRECTOR
References: