Fibroid Ablation Study - Large Fibroids

Not Applicable

Terminated

• Conditions: Menorrhagia; Leiomyoma; Uterine Fibroids
• Interventions: Device: VizAblate System

• Registration Number: NCT01539187
• Lead Sponsor: Gynesonics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-02-27
• Study Start: 2012-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VizAblate intervention	VizAblate System	VizAblate System with subject serving as her own control

Primary Outcome Measures

Name	Time	Method
Mean percentage change in target fibroid perfused volume	Baseline, 3 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Percentage reduction in Menstrual Pictogram score	through 12 months
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 Symptom Severity Score (SSS) subscale 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

Trial Locations

Locations (10)

Maxima Medisch Centrum; 🇳🇱 Veldhoven, Noord-Brabant, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Utrecht, Netherlands

Universidad Autonoma de Nuevo Leon (UANL); 🇲🇽 Monterrey, Nuevo Leon, Mexico

Medisch Spectrum Twente; 🇳🇱 Enschede, Overijssel, Netherlands

Bradford Teaching Hospitals NHS Trust; 🇬🇧 Bradford, West Yorkshire, United Kingdom

University College Hospital; 🇬🇧 London, United Kingdom

Royal London Hospital; 🇬🇧 Whitechapel, London, United Kingdom

Birmingham Women's NHS Foundation Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom

Princess Royal Hospital; 🇬🇧 Haywards Heath, West Sussex, United Kingdom

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, North Holland, Netherlands