NCT00768742

Brief Summary

The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

October 6, 2008

Last Update Submit

November 22, 2013

Conditions

LeiomyomaUterine FibroidsMenorrhagia

Keywords

Uterine Fibroid RF AblationIntrauterine UltrasoundVizAblate

Outcome Measures

Primary Outcomes (1)

  • Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)

    Baseline, 3 mo, 6 mo, 9 mo, 12 mo

Secondary Outcomes (7)

  • Rate of surgical reintervention

    12 mo

  • Quality of Life questionnaires

    Baseline, 3 mo, 6 mo, 9 mo, 12 mo

  • Time required to return to normal daily activity

    7-14 days

  • Adverse events

    At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo.

  • Subject tolerance of procedure rated via analog visual scale

    Discharge

  • +2 more secondary outcomes

Interventions

VizAblate Intrauterine Ultrasound-Guided RF AblationDEVICE

VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-menopausal
  • Regular, consistent menstrual cycles
  • Serum progesterone \> 6 ng/ml (19 nmol/L)
  • months history of PBLAC score of 150-500
  • Maximum of 4 type I, type II, or intramural fibroids
  • Patient is at low risk for cervical cancer
  • Hemoglobin \> 6 g/dl
  • Not at risk for pregnancy
  • No desire for future fertility
  • Willing and able to complete the follow-up requirements outlined in the study design section of the protocol
  • Willing to sign a consent form

You may not qualify if:

  • Subserosal fibroids.
  • Any fibroid that obstructs access to the endometrial cavity
  • FSH \> 20 IU/L
  • Pregnancy
  • Evidence of disorders of hemostasis
  • Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen
  • SERMS/SPRMS within the last 6 months
  • Current use of any IUD or use of Mirena IUS within the last 3 months
  • Gynecological malignancy or hyperplasia
  • Known/suspected abdominal/pelvic cancer
  • Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease)
  • Adenomyosis
  • Previous surgical or ablative treatment for fibroids or menorrhagia
  • Previous uterine artery embolization or occlusion
  • Patient on anti-coagulation therapy
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Victoria General Hospital; Mature Women's Centre

Winnipeg, Manitoba, R3T 2A8, Canada

Location

Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, M6R 1B5, Canada

Location

MeSH Terms

Conditions

LeiomyomaMenorrhagia

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Officials

  • David Toub, M.D.

    Gynesonics

    STUDY DIRECTOR
0

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 6, 2008

First Posted

October 8, 2008

Study Start

September 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

CA(3)