Clinical trial NCT01226290: Fibroid Ablation Study
Official title: Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of 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: 2010-10-22
Enrollment: 51
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 primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.


Eligibility criteria: 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

Primary outcomes:
measure: Mean percentage change in target fibroid perfused volume
timeFrame: 3 months
Secondary outcomes:
measure: Number of adverse events
timeFrame: procedure through 12 mo
measure: Percentage reduction in Menstrual Pictogram score
timeFrame: baseline through 12 months
measure: Percentage reduction in the Symptom Severity Subscale (SSS) 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
Other outcomes:
measure: Subject satisfaction
timeFrame: 3 month, 6 month, 12 months
measure: Anesthesia regimen
timeFrame: Day of procedure
measure: System ease of use
timeFrame: End of study
measure: Subject pain and tolerance of procedure
timeFrame: Day of procedure
measure: HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire
timeFrame: 3 month, 6 month, 12 months
measure: EuroQOL EQ-5D
timeFrame: 3 month, 6 month, 12 month
measure: Length of Stay
timeFrame: Day of procedure
measure: Nonsurgical reintervention for menorrhagia
timeFrame: 30 day, 3 month, 6 month, 12 month
Locations:
city: Monterrey
country: Mexico
facility: Universidad Autonoma de Nuevo Leon (UANL)
state: Nuevo Leon
city: Veldhoven
country: Netherlands
facility: Máxima Medisch Centrum
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
state: North Holland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
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 Health
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:
citation: Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021 Oct;155(1):79-85. doi: 10.1002/ijgo.13638. Epub 2021 Mar 17.