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

Health Conditions
  • Leiomyoma
  • Uterine Fibroids
  • Menorrhagia
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.
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
Research Question
  • The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
Mexico; Netherlands; United Kingdom
Participant Sex
Female
Participant Age Range
28 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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
  • 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
Interventions
Device; VizAblate System; VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.; [VizAblate treatment]
Design Details
Sorry, this information is not available
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
FAST-EU
Scientific Title
Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids
Secondary Trial Identifying Number
Sorry, this information is not available
Website
Sorry, this information is not available
Study Funded By
Gynesonics
Funder Type
Sorry, this information is not available
Study Sponsored By
Gynesonics
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

20 Oct 2010

Last Updated

13 Mar 2015

Date Record Refreshed on UKCTG

31 Jul 2015