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FAST-L: Fibroid Ablation Study - Large Fibroids

Sponsor
Gynesonics (Industry)
Overall Status
Terminated
CT.gov ID
NCT01539187
Collaborator
(none)
6
Enrollment
10
Locations
1
Arm
24
Duration (Months)
0.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VizAblate System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: VizAblate intervention

VizAblate System with subject serving as her own control

Device: VizAblate System
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy

Outcome Measures

Primary Outcome Measures

  1. Mean percentage change in target fibroid perfused volume [Baseline, 3 months, 12 months]

Secondary Outcome Measures

  1. Number of adverse events [Procedure through 12 mo]

    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.

  2. Percentage reduction in Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) Questionnaire [Baseline through 12 months]

  3. Rate of surgical reintervention for menorrhagia [through 12 months]

  4. Return to normal daily activity [2 weeks or until returned to normal activity]

  5. Percentage reduction in Menstrual Pictogram score [through 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
28 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Autonoma de Nuevo Leon (UANL) Monterrey Nuevo Leon Mexico 64460
2 Maxima Medisch Centrum Veldhoven Noord-Brabant Netherlands 5500
3 Vrije Universiteit Medisch Centrum Amsterdam North Holland Netherlands 1007
4 Medisch Spectrum Twente Enschede Overijssel Netherlands 7513 ER
5 St. Antonius Ziekenhuis Nieuwegein Utrecht Netherlands 3430
6 Royal London Hospital Whitechapel London United Kingdom E1 1BB
7 Birmingham Women's NHS Foundation Trust Birmingham West Midlands United Kingdom B15 2TG
8 Princess Royal Hospital Haywards Heath West Sussex United Kingdom RH16 3EJ
9 Bradford Teaching Hospitals NHS Trust Bradford West Yorkshire United Kingdom BD9 6RJ
10 University College Hospital London United Kingdom NW1 2BU

Sponsors and Collaborators

  • Gynesonics

Investigators

  • Study Director: David Toub, MD, Gynesonics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gynesonics
ClinicalTrials.gov Identifier:
NCT01539187
Other Study ID Numbers:
  • CL 03536
First Posted:
Feb 27, 2012
Last Update Posted:
Mar 17, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Gynesonics
uterine fibroid RF ablation
intrauterine ultrasound
VizAblate
Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Menorrhagia

Study Results

No Results Posted as of Mar 17, 2015