Fibroid Ablation Study (FAST-EU)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gynesonics
ClinicalTrials.gov Identifier:
NCT01226290
First received: October 20, 2010
Last updated: July 16, 2014
Last verified: July 2014

October 20, 2010
July 16, 2014
January 2011
September 2014   (final data collection date for primary outcome measure)
Mean percentage change in target fibroid perfused volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Mean percentage change in target fibroid perfused volume [ Time Frame: Baseline, at procedure, 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01226290 on ClinicalTrials.gov Archive Site
  • Number of adverse events [ Time Frame: procedure through 12 mo ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline through 12 months ] [ Designated as safety issue: No ]
  • Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire [ Time Frame: baseline through 12 months ] [ Designated as safety issue: No ]
  • Rate of surgical reintervention for menorrhagia [ Time Frame: through 12 months ] [ Designated as safety issue: No ]
  • Return to normal daily activity [ Time Frame: 2 weeks or until returned to normal activity ] [ Designated as safety issue: No ]
Same as current
  • Subject satisfaction [ Time Frame: 3 month, 6 month, 12 months ] [ Designated as safety issue: No ]
  • Anesthesia regimen [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
  • System ease of use [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Subject pain and tolerance of procedure [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
  • HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire [ Time Frame: 3 month, 6 month, 12 months ] [ Designated as safety issue: No ]
  • EuroQOL EQ-5D [ Time Frame: 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
  • Length of Stay [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
  • Nonsurgical reintervention for menorrhagia [ Time Frame: 30 day, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
Not Provided
 
Fibroid Ablation Study
Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids

The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leiomyoma
  • Uterine Fibroids
  • Menorrhagia
Device: VizAblate System
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.
Experimental: VizAblate treatment
VizAblate System: subject acts as her own control
Intervention: Device: VizAblate System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
June 2015
September 2014   (final data collection date for primary outcome measure)

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
Female
28 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Netherlands,   Mexico
 
NCT01226290
CL02413
No
Gynesonics
Gynesonics
Not Provided
Study Director: David Toub, MD Gynesonics
Gynesonics
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP