Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gynesonics
ClinicalTrials.gov Identifier:
NCT01998854
First received: November 25, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

Study is intended to evaluate the one-year safety and clinical status of patients treated for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio frequency (RF) ablation system. Particular attention will be directed to recording safety outcomes including incidence of uterine cavity synechiae. In addition, information on quality of life will be collected.

Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.


Condition Intervention
Menorrhagia
Leiomyoma
Uterine Fibroids
Uterine Fibroma
Uterine Neoplasms
Device: VizAblate System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation

Resource links provided by NLM:


Further study details as provided by Gynesonics:

Primary Outcome Measures:
  • Mean percentage change in treated fibroid perfused volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fibroid total volume reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of Intrauterine adhesiogenesis [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    The cavity will be as classified per the European Society for Hysteroscopy (ESH)

  • Procedure Safety [ Time Frame: Day of procedure ] [ Designated as safety issue: Yes ]
    Frequency and type of adverse events occurring on the day of the procedure

  • Long-term safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Frequency and type of adverse events occurring post treatment through 12 months

  • Percentage reduction in the Symptom Severity Score sub scale of the Uterine Fibroid Symptom - Quality of Life questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage increase in the Health Related Quality-of-Life (HRQL) sub scale of the Uterine Fibroid Symptom-Quality of Life questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of surgical reintervention for menorrhagia [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
VizAblate treatment
VizAblate System with subject serving as her own control
Device: VizAblate System
The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids

Detailed Description:

In this single-arm study, subjects who receive transcervical intrauterine-ultrasound guided RF ablation of symptomatic uterine fibroids with the VizAblate® System will be assessed with 3D pelvic sonography with contrast, hysteroscopy, and quality of life questionnaires.

Overall study duration (first patient enrolled through last patient exit) will be comprised of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment, and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an individual patient, once enrolled, will be approximately 1 month for baseline observations and treatment scheduling, and 12 months for follow up after treatment for a total duration of approximately 13 months.

  Eligibility

Ages Eligible for Study:   28 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of specified clinical sites with complaint of symptomatic uterine fibroids.

Criteria

Inclusion Criteria:

  • 28 years of age or older
  • Indication for transcervical treatment of uterine fibroids associated with menorrhagia
  • Willingness to participate in the study, to attend all follow-up visits and undergo all study assessments, and to sign the informed consent form
  • Presence of submucosal and/or intramural fibroids

Exclusion Criteria:

  • Pregnancy
  • ≥40 years of age with desire for current or future fertility, unless the estimated risk/benefit ratio has been determined to be more favorable to future pregnancy than standard therapy
  • Non-sterilized patients < 40 years of age, unless the estimated risk/benefit ratio has been determined to be more favorable to future pregnancy than standard therapy
  • Active pelvic infection, known or suspected gynecologic malignancy or premalignant condition
  • Presence of tubal implant for sterilization
  • Previous pelvic irradiation
  • Endometrial cavity length, including endocervical canal, < 4.5 cm
  • Any abnormality of the vagina or uterine cavity that, in the judgment of the investigator obstructs access of the VizAblate handpiece to the endometrial cavity
  • Presence of cardiac pacemaker or other active implant
  • Post-menopausal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998854

Locations
France
Le Centre Hospitalier Regional et Universitaire de Tours - Hôpital Bretonneau
Tours, Cedex, France, 37044
Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre
Paris, France, 75475
Sponsors and Collaborators
Gynesonics
Investigators
Study Director: David Toub, MD Gynesonics
  More Information

No publications provided

Responsible Party: Gynesonics
ClinicalTrials.gov Identifier: NCT01998854     History of Changes
Other Study ID Numbers: CL03537
Study First Received: November 25, 2013
Last Updated: November 25, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Gynesonics:
Menorrhagia
Leiomyoma
Uterine Fibroids

Additional relevant MeSH terms:
Neoplasms
Fibroma
Leiomyoma
Myofibroma
Menorrhagia
Uterine Neoplasms
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on August 21, 2014