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Fibroid Ablation Study - Large Fibroids (FAST-L)

Primary Purpose

Leiomyoma, Uterine Fibroids, Menorrhagia

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VizAblate System
Sponsored by
Gynesonics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyoma focused on measuring uterine fibroid RF ablation, intrauterine ultrasound, VizAblate

Eligibility Criteria

28 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Autonoma de Nuevo Leon (UANL)
  • Maxima Medisch Centrum
  • Vrije Universiteit Medisch Centrum
  • Medisch Spectrum Twente
  • St. Antonius Ziekenhuis
  • Royal London Hospital
  • Birmingham Women's NHS Foundation Trust
  • Princess Royal Hospital
  • Bradford Teaching Hospitals NHS Trust
  • University College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VizAblate intervention

Arm Description

VizAblate System with subject serving as her own control

Outcomes

Primary Outcome Measures

Mean percentage change in target fibroid perfused volume

Secondary Outcome Measures

Number of adverse events
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
Rate of surgical reintervention for menorrhagia
Return to normal daily activity
Percentage reduction in Menstrual Pictogram score

Full Information

First Posted
February 21, 2012
Last Updated
March 13, 2015
Sponsor
Gynesonics
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1. Study Identification

Unique Protocol Identification Number
NCT01539187
Brief Title
Fibroid Ablation Study - Large Fibroids
Acronym
FAST-L
Official Title
Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Investigational device changes
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynesonics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma, Uterine Fibroids, Menorrhagia
Keywords
uterine fibroid RF ablation, intrauterine ultrasound, VizAblate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VizAblate intervention
Arm Type
Experimental
Arm Description
VizAblate System with subject serving as her own control
Intervention Type
Device
Intervention Name(s)
VizAblate System
Intervention Description
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy
Primary Outcome Measure Information:
Title
Mean percentage change in target fibroid perfused volume
Time Frame
Baseline, 3 months, 12 months
Secondary Outcome Measure Information:
Title
Number of adverse events
Description
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.
Time Frame
Procedure through 12 mo
Title
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
Title
Rate of surgical reintervention for menorrhagia
Time Frame
through 12 months
Title
Return to normal daily activity
Time Frame
2 weeks or until returned to normal activity
Title
Percentage reduction in Menstrual Pictogram score
Time Frame
through 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Toub, MD
Organizational Affiliation
Gynesonics
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Autonoma de Nuevo Leon (UANL)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Maxima Medisch Centrum
City
Veldhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5500
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1007
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overijssel
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3430
Country
Netherlands
Facility Name
Royal London Hospital
City
Whitechapel
State/Province
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Birmingham Women's NHS Foundation Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TG
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Haywards Heath
State/Province
West Sussex
ZIP/Postal Code
RH16 3EJ
Country
United Kingdom
Facility Name
Bradford Teaching Hospitals NHS Trust
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom

12. IPD Sharing Statement

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Fibroid Ablation Study - Large Fibroids

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