Fibroid Ablation Study - Large Fibroids

NCT01539187 | Terminated

• 1 other identifier: CL 03536
• Study Type: interventional
• Target: 6
• Locations: 3 countries
• Sites: 10

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.

Conditions

Leiomyoma; Uterine Fibroids; Menorrhagia

Keywords

uterine fibroid RF ablation; intrauterine ultrasound; VizAblate

Outcome Measures

Primary Outcomes (1)

• Mean percentage change in target fibroid perfused volume

  Baseline, 3 months, 12 months

Secondary Outcomes (5)

• 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

Study Arms (1)

VizAblate intervention

EXPERIMENTAL

VizAblate System with subject serving as her own control

Device: VizAblate System

Interventions

VizAblate System DEVICE

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

VizAblate intervention

Eligibility Criteria

• Age: 28 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynesonics: lead

Study Sites (10)

Universidad Autonoma de Nuevo Leon (UANL)

Monterrey, Nuevo León, 64460, Mexico

Location

Maxima Medisch Centrum

Veldhoven, North Brabant, 5500, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, North Holland, 1007, Netherlands

Location

Medisch Spectrum Twente

Enschede, Overijssel, 7513 ER, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3430, Netherlands

Location

University College Hospital

London, London, NW1 2BU, United Kingdom

Location

Royal London Hospital

Whitechapel, London, E1 1BB, United Kingdom

Location

Birmingham Women's NHS Foundation Trust

Birmingham, West Midlands, B15 2TG, United Kingdom

Location

Princess Royal Hospital

Haywards Heath, West Sussex, RH16 3EJ, United Kingdom

Location

Bradford Teaching Hospitals NHS Trust

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

MeSH Terms

Conditions

Leiomyoma; Menorrhagia

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• David Toub, MD

  Gynesonics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: February 27, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

NL (4); ME (1); GB (5)