Fibroid Ablation Study

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-03-31

Brief Summary

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The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating 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 treatment

VizAblate System: subject acts 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
* 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 Criteria

* 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

Minimum Eligible Age

28 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No