Fibroid Ablation Study

Uterine Fibroids Clinical Trial

— FAST-EU  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01226290
• Other study ID #: CL02413
• Status: Terminated
• Phase: N/A
• First received: October 20, 2010
• Last updated: March 13, 2015
• Start date: January 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Gynesonics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks ProtectionUnited Kingdom: Research Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 28 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Menorrhagia
• Uterine Fibroids

Intervention

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

Locations

Country	Name	City	State
Mexico	Universidad Autonoma de Nuevo Leon (UANL)	Monterrey	Nuevo Leon
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam	North Holland
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht
Netherlands	Máxima Medisch Centrum	Veldhoven	Noord-Brabant
United Kingdom	Birmingham Women's NHS Foundation Trust	Birmingham	West Midlands
United Kingdom	Bradford Teaching Hospitals NHS Trust	Bradford	West Yorkshire
United Kingdom	Princess Royal Hospital	Haywards Health	West Sussex
United Kingdom	University College Hospital	London
United Kingdom	Royal London Hospital	Whitechapel	London

Sponsors (1)

Lead Sponsor	Collaborator
Gynesonics

Countries where clinical trial is conducted

Mexico,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject satisfaction		3 month, 6 month, 12 months	No
Other	Anesthesia regimen		Day of procedure	No
Other	System ease of use		End of study	No
Other	Subject pain and tolerance of procedure		Day of procedure	No
Other	HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire		3 month, 6 month, 12 months	No
Other	EuroQOL EQ-5D		3 month, 6 month, 12 month	No
Other	Length of Stay		Day of procedure	No
Other	Nonsurgical reintervention for menorrhagia		30 day, 3 month, 6 month, 12 month	No
Primary	Mean percentage change in target fibroid perfused volume		3 months	No
Secondary	Number of adverse events	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.	procedure through 12 mo	Yes
Secondary	Percentage reduction in Menstrual Pictogram score		baseline through 12 months	No
Secondary	Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire		baseline through 12 months	No
Secondary	Rate of surgical reintervention for menorrhagia		through 12 months	No
Secondary	Return to normal daily activity		2 weeks or until returned to normal activity	No