Fibroid Ablation Study - Large Fibroids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Leiomyoma Uterine Fibroids Menorrhagia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VizAblate intervention

VizAblate System with subject serving as her own control

Group Type EXPERIMENTAL

VizAblate System

Intervention Type DEVICE

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

Interventions

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VizAblate System

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

28 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No