Fibroid Ablation Study - Large Fibroids (FAST-L)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gynesonics
ClinicalTrials.gov Identifier:
NCT01539187
First received: February 21, 2012
Last updated: November 22, 2013
Last verified: November 2013

February 21, 2012
November 22, 2013
June 2012
September 2014   (final data collection date for primary outcome measure)
Mean percentage change in target fibroid perfused volume [ Time Frame: Baseline, 3 months, 12 months ] [ Designated as safety issue: No ]
Mean percentage change in target fibroid perfused volume [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01539187 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 Symptom Severity Score (SSS) subscale 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 ]
  • Percentage reduction in Menstrual Pictogram score [ Time Frame: through 12 months ] [ Designated as safety issue: No ]
  • 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 Symptom Severity Score (SSS) subscale 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 ]
Not Provided
Not Provided
 
Fibroid Ablation Study - Large Fibroids
Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: 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 intervention
VizAblate System with subject serving 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
48
June 2015
September 2014   (final data collection date for primary outcome measure)

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
Female
28 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico,   Netherlands,   United Kingdom
 
NCT01539187
CL 03536
No
Gynesonics
Gynesonics
Not Provided
Study Director: David Toub, MD Gynesonics
Gynesonics
November 2013

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