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Clinical Trials/NCT01539187
NCT01539187TerminatedNot Applicable

Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids

Gynesonics20 sites in 3 countries6 target enrollmentStarted: June 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
6
Locations
20
Primary Endpoint
Mean percentage change in target fibroid perfused volume
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
28 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Mean percentage change in target fibroid perfused volume

Time Frame: Baseline, 3 months, 12 months

Secondary Outcomes

  • Number of adverse events(Procedure through 12 mo)
  • Percentage reduction in Symptom Severity Score (SSS) subscale 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)
  • Percentage reduction in Menstrual Pictogram score(through 12 months)

Investigators

Sponsor
Gynesonics
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (20)

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