Fibroid Ablation Study (FAST-EU)
This study is currently recruiting participants.
Verified October 2012 by Gynesonics
Sponsor:
Gynesonics
Information provided by (Responsible Party):
Gynesonics
ClinicalTrials.gov Identifier:
NCT01226290
First received: October 20, 2010
Last updated: October 10, 2012
Last verified: October 2012
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Purpose
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
| Condition | Intervention |
|---|---|
|
Leiomyoma Uterine Fibroids Menorrhagia |
Device: VizAblate System |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids |
Further study details as provided by Gynesonics:
Primary Outcome Measures:
- Mean percentage change in target fibroid perfused volume [ Time Frame: Baseline, at procedure, 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 Menstrual Pictogram score [ Time Frame: baseline through 12 months ] [ Designated as safety issue: No ]
- Percentage reduction in the Symptom Severity Subscale (SSS) 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 ]
| Estimated Enrollment: | 48 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: VizAblate treatment
VizAblate System: subject acts 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.
|
Eligibility| Ages Eligible for Study: | 28 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 28 years of age or older
- Regular, consistent menstrual cycles
- Objective evidence of normal ovulatory function
- 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
- 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
- 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)
- Current use of any intrauterine device (IUD) or use of Mirena® intrauterine system (IUS)
- 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 surgical, embolizational, or ablative treatment for fibroids or menorrhagia
- 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
- Uterine size > 12 weeks
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226290
Contacts
| Contact: Diane M King, RAC | 650-216-3883 | dking@gynesonics.com |
| Contact: David Toub, M.D. | (215) 882-3420 | dtoub@gynesonics.com |
Locations
| Mexico | |
| Universidad Autonoma de Nuevo Leon (UANL) | Recruiting |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Contact: José G Garza Leal, M.D. +52 (81) 8106-9716 drjoseggarza@prodigy.net.mx | |
| Principal Investigator: José G Garza Leal, M.D. | |
| Netherlands | |
| Máxima Medisch Centrum | Recruiting |
| Veldhoven, Noord-Brabant, Netherlands, 5500 | |
| Contact: Marlies Bongers, MD PhD 011 31 40 888 8384 Gynaecologie.Secr@mmc.nl | |
| Principal Investigator: Marlies Bongers, MD PhD | |
| Vrije Universiteit Medisch Centrum | Recruiting |
| Amsterdam, North Holland, Netherlands, 1007 | |
| Contact: Hans Brölmann, MD, PhD 011-31-20-444-2227 H.Brolmann@vumc.nl | |
| Principal Investigator: Hans Brölmann, MD, PhD | |
| St. Antonius Ziekenhuis | Recruiting |
| Nieuwegein, Utrecht, Netherlands, 3430 | |
| Contact: Sebastiaan Veersema, MD 011 31 30 609 20 86 s.veersema@antoniusziekenhuis.nl | |
| Principal Investigator: Sebastiaan Veersema, MD | |
| Medisch Spectrum Twente | Recruiting |
| Enschede, Netherlands, 7513 ER | |
| Contact: Hendrik Quartero, MD PhD FRCOG 053 487 2334 rik@quartero.nl | |
| Principal Investigator: Hendrik Quartero, MD PhD FRCOG | |
| United Kingdom | |
| Royal London Hospital | Recruiting |
| Whitechapel, London, United Kingdom, E1 1BB | |
| Contact: Elizabeth Ball, MD MRCOG +44 20 7377 7217 Elizabeth.Ball@bartsandthelondon.nhs.uk | |
| Principal Investigator: Elizabeth Ball, MD, MRCOG | |
| Birmingham Women's NHS Foundation Trust | Recruiting |
| Birmingham, West Midlands, United Kingdom, B15 2TG | |
| Contact: Janesh K. Gupta, MBChB MSc MD 011 44 121 607 4751 j.k.gupta@bham.ac.uk | |
| Principal Investigator: Janesh K Gupta, MBChB MSc MD | |
| Princess Royal Hospital | Recruiting |
| Haywards Health, West Sussex, United Kingdom, RH16 3EJ | |
| Contact: Greg Kalu, MBBS FRCOG gregory.kalu@bsuh.nhs.uk | |
| Principal Investigator: Greg Kalu, MBBS FRCOG | |
| Bradford Teaching Hospitals NHS Trust | Recruiting |
| Bradford, West Yorkshire, United Kingdom, BD9 6RJ | |
| Contact: Siân Jones, M.D. 44 1274 364568 sian.jones@bradfordhospitals.nhs.uk | |
| Principal Investigator: Siân Jones, M.D. | |
| University College Hospital | Recruiting |
| London, United Kingdom, NW1 2BU | |
| Contact: Ertan Saridogan, PhD FRCOG ertan.saridogan@uclh.nhs.uk | |
| Principal Investigator: Ertan Saridogan, PhD FRCOG | |
Sponsors and Collaborators
Gynesonics
Investigators
| Study Director: | David Toub, MD | Gynesonics |
More Information
No publications provided
| Responsible Party: | Gynesonics |
| ClinicalTrials.gov Identifier: | NCT01226290 History of Changes |
| Other Study ID Numbers: | CL02413 |
| Study First Received: | October 20, 2010 |
| Last Updated: | October 10, 2012 |
| Health Authority: | Mexico: Federal Commission for Sanitary Risks Protection United Kingdom: Research Ethics Committee Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Gynesonics:
|
uterine fibroid RF ablation intrauterine ultrasound VizAblate |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Menorrhagia Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Neoplasms, Connective Tissue Connective Tissue Diseases Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Menstruation Disturbances Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013