Fibroid Ablation Study | Stopped
Fibroid Ablation Study
FAST-EU
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Leiomyoma
  • Uterine Fibroids
  • Menorrhagia
Unfortunately contact details are not available for this trial.
Primary Contact Details
Stopped
Recruitment Status
NCT01226290
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Device : VizAblate System

Study Arm Groups : VizAblate treatment

Intervention Type
See Interventions above
Primary Outcome Measures
  • Mean percentage change in target fibroid perfused volume; 3 months
Secondary Outcome Measures
  • Number of adverse events; procedure through 12 mo; Percentage reduction in Menstrual Pictogram score; baseline through 12 months; Percentage reduction in the Symptom Severity Subscale (SSS) 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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Female
Age Range
28 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
GSK Investigational Site
Bradford
BD9 6RJ
Birmingham Womens Hospital
Birmingham
West Midlands
B15 2TG
University College London
London
NW1 2BU
Royal London Hospital
Whitechapel
London
E1 1BB
Princess Royal Hospital
Haywards Health
West Sussex
RH16 3EJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Mexico, Netherlands, United Kingdom
Scientific Title
Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CL02413
Sponsor(s)
Gynesonics
Key Dates

Recruitment Start Date

Jan 2011

Recruitment End Date

Mar 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

20 Oct 2010

Last Updated

13 Mar 2015