Status:
TERMINATED
Fibroid Ablation Study
Lead Sponsor:
Gynesonics
Conditions:
Leiomyoma
Uterine Fibroids
Eligibility:
FEMALE
28+ years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01226290
Start Date
January 1 2011
End Date
March 1 2014
Last Update
April 2 2015
Active Locations (10)
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1
Universidad Autonoma de Nuevo Leon (UANL)
Monterrey, Nuevo León, Mexico, 64460
2
Máxima Medisch Centrum
Veldhoven, North Brabant, Netherlands, 5500
3
Vrije Universiteit Medisch Centrum
Amsterdam, North Holland, Netherlands, 1007
4
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands, 3430