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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01226290
Other study ID # CL02413
Secondary ID
Status Terminated
Phase N/A
First received October 20, 2010
Last updated March 13, 2015
Start date January 2011
Est. completion date March 2014

Study information

Verified date March 2015
Source Gynesonics
Contact n/a
Is FDA regulated No
Health authority Mexico: Federal Commission for Sanitary Risks ProtectionUnited Kingdom: Research Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 51
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Female
Age group 28 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Mexico Universidad Autonoma de Nuevo Leon (UANL) Monterrey Nuevo Leon
Netherlands Vrije Universiteit Medisch Centrum Amsterdam North Holland
Netherlands Medisch Spectrum Twente Enschede
Netherlands St. Antonius Ziekenhuis Nieuwegein Utrecht
Netherlands Máxima Medisch Centrum Veldhoven Noord-Brabant
United Kingdom Birmingham Women's NHS Foundation Trust Birmingham West Midlands
United Kingdom Bradford Teaching Hospitals NHS Trust Bradford West Yorkshire
United Kingdom Princess Royal Hospital Haywards Health West Sussex
United Kingdom University College Hospital London
United Kingdom Royal London Hospital Whitechapel London

Sponsors (1)

Lead Sponsor Collaborator
Gynesonics

Countries where clinical trial is conducted

Mexico,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Subject satisfaction 3 month, 6 month, 12 months No
Other Anesthesia regimen Day of procedure No
Other System ease of use End of study No
Other Subject pain and tolerance of procedure Day of procedure No
Other HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire 3 month, 6 month, 12 months No
Other EuroQOL EQ-5D 3 month, 6 month, 12 month No
Other Length of Stay Day of procedure No
Other Nonsurgical reintervention for menorrhagia 30 day, 3 month, 6 month, 12 month No
Primary Mean percentage change in target fibroid perfused volume 3 months No
Secondary Number of adverse events Procedure safety will be assessed by recording all adverse events that occur on the day of the procedure. Longer-term safety will be assessed by recording at each follow-up visit any untoward medical occurrence since baseline. Each adverse event will be assessed for severity and relationship to study device. procedure through 12 mo Yes
Secondary Percentage reduction in Menstrual Pictogram score baseline through 12 months No
Secondary Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire baseline through 12 months No
Secondary Rate of surgical reintervention for menorrhagia through 12 months No
Secondary Return to normal daily activity 2 weeks or until returned to normal activity No
See also
  Status Clinical Trial Phase
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Completed NCT00958334 - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Phase 2
Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A