Fibroid Ablation Study

NCT01226290 | Terminated

• 1 other identifier: CL02413
• Study Type: interventional
• Target: 51
• Locations: 3 countries
• Sites: 10

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.

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

  3 months

Secondary Outcomes (5)

• Number of adverse events

  procedure through 12 mo

• Percentage reduction in Menstrual Pictogram score

  baseline through 12 months

• Percentage reduction in the Symptom Severity Subscale (SSS) 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

Other Outcomes (8)

• Subject satisfaction

  3 month, 6 month, 12 months

• Anesthesia regimen

  Day of procedure

• System ease of use

  End of study

Study Arms (1)

VizAblate treatment

EXPERIMENTAL

VizAblate System: subject acts 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 treatment

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gynesonics: lead

Study Sites (10)

Universidad Autonoma de Nuevo Leon (UANL)

Monterrey, Nuevo León, 64460, Mexico

Location

Máxima Medisch Centrum

Veldhoven, North Brabant, 5500, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, North Holland, 1007, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3430, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7513 ER, 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 Health, West Sussex, RH16 3EJ, United Kingdom

Location

Bradford Teaching Hospitals NHS Trust

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Related Publications (1)

• Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021 Oct;155(1):79-85. doi: 10.1002/ijgo.13638. Epub 2021 Mar 17.

  PMID: 33544889 DERIVED

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: October 20, 2010
• First Posted: October 22, 2010
• Study Start: January 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 2, 2015

Record last verified: 2015-03

Locations

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