Fibroid Ablation Study - Large Fibroids

Uterine Fibroids Clinical Trial

— FAST-L  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01539187
• Other study ID #: CL 03536
• Status: Terminated
• Phase: N/A
• First received: February 21, 2012
• Last updated: March 13, 2015
• Start date: June 2012
• Est. completion date: June 2014

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 28 Years and older

Eligibility

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

Study Design

Endpoint Classification: 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	Overijssel
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht
Netherlands	Maxima 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 Heath	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
Primary	Mean percentage change in target fibroid perfused volume		Baseline, 3 months, 12 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 Symptom Severity Score (SSS) subscale 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
Secondary	Percentage reduction in Menstrual Pictogram score		through 12 months	No