FAST-EU: Fibroid Ablation Study

Sponsor

Gynesonics (Industry)

Overall Status

Terminated

CT.gov ID

NCT01226290

Collaborator

(none)

Enrollment

Locations

Arm

37.9

Duration (Months)

5.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leiomyoma Uterine Fibroids Menorrhagia	Device: VizAblate System	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VizAblate treatment VizAblate System: subject acts as her own control	Device: VizAblate System VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.

Arm

Intervention/Treatment

Experimental: VizAblate treatment

VizAblate System: subject acts as her own control

Device: VizAblate System

VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.

Outcome Measures

Primary Outcome Measures

Mean percentage change in target fibroid perfused volume [3 months]

Secondary Outcome Measures

Number of adverse events [procedure through 12 mo]
Procedure safety will be assessed by recording all adverse events that occur on the day of the procedure. Longer-term safety will be assessed by recording at each follow-up visit any untoward medical occurrence since baseline. Each adverse event will be assessed for severity and relationship to study device.
Percentage reduction in Menstrual Pictogram score [baseline through 12 months]
Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire [baseline through 12 months]
Rate of surgical reintervention for menorrhagia [through 12 months]
Return to normal daily activity [2 weeks or until returned to normal activity]

Other Outcome Measures

Subject satisfaction [3 month, 6 month, 12 months]
Anesthesia regimen [Day of procedure]
System ease of use [End of study]
Subject pain and tolerance of procedure [Day of procedure]
HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire [3 month, 6 month, 12 months]
EuroQOL EQ-5D [3 month, 6 month, 12 month]
Length of Stay [Day of procedure]
Nonsurgical reintervention for menorrhagia [30 day, 3 month, 6 month, 12 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Autonoma de Nuevo Leon (UANL)	Monterrey	Nuevo Leon	Mexico	64460
2	Máxima Medisch Centrum	Veldhoven	Noord-Brabant	Netherlands	5500
3	Vrije Universiteit Medisch Centrum	Amsterdam	North Holland	Netherlands	1007
4	St. Antonius Ziekenhuis	Nieuwegein	Utrecht	Netherlands	3430
5	Medisch Spectrum Twente	Enschede		Netherlands	7513 ER
6	Royal London Hospital	Whitechapel	London	United Kingdom	E1 1BB
7	Birmingham Women's NHS Foundation Trust	Birmingham	West Midlands	United Kingdom	B15 2TG
8	Princess Royal Hospital	Haywards Health	West Sussex	United Kingdom	RH16 3EJ
9	Bradford Teaching Hospitals NHS Trust	Bradford	West Yorkshire	United Kingdom	BD9 6RJ
10	University College Hospital	London		United Kingdom	NW1 2BU