NCT01998854

Brief Summary

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

November 25, 2013

Last Update Submit

March 9, 2015

Conditions

MenorrhagiaLeiomyomaUterine FibroidsUterine FibromaUterine Neoplasms

Keywords

MenorrhagiaLeiomyomaUterine Fibroids

Outcome Measures

Primary Outcomes (1)

  • Mean percentage change in treated fibroid perfused volume

    12 months

Secondary Outcomes (7)

  • Fibroid total volume reduction

    12 months

  • Incidence of Intrauterine adhesiogenesis

    7 weeks

  • Procedure Safety

    Day of procedure

  • Long-term safety

    12 months

  • Percentage reduction in the Symptom Severity Score sub scale of the Uterine Fibroid Symptom - Quality of Life questionnaire

    12 months

  • +2 more secondary outcomes

Study Arms (1)

VizAblate treatment

VizAblate System with subject serving as her own control

Device: VizAblate System

Interventions

VizAblate SystemDEVICE

The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids

VizAblate treatment

Eligibility Criteria

Age28 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Le Centre Hospitalier Regional et Universitaire de Tours - Hôpital Bretonneau

Tours, Cedex, 37044, France

Location

Assistance Publique Hôpitaux de Paris - Hôpital Bicêtre

Paris, 75475, France

Location

MeSH Terms

Conditions

MenorrhagiaLeiomyomaUterine Neoplasms

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Study Officials

  • David Toub, MD

    Gynesonics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 2, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2014

Study Completion

January 1, 2015

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

FR(2)