NCT00180739

Brief Summary

The study objective is to develop data for the safety of pregnancies after thermal ablation of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.

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 Apr 2004

Geographic Reach
1 country

1 active site

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withdrawn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

April 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

September 13, 2005

Last Update Submit

October 20, 2023

Conditions

Uterine FibroidsPregnancy

Keywords

MR guided FUSUterine FibroidsFertilityPregnancy

Outcome Measures

Primary Outcomes (1)

  • Pregnancy outcomes in women who have received treatment with MRgFUS

Secondary Outcomes (1)

  • Efficacy of MRgFUS as judged by HRQOL questionnaires

Interventions

Magnetic Resonance Guided Focused UltrasoundPROCEDURE

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Subject with uterine fibroids, who desire pregnancy within 12 months and has the one of the following criteria: Women 20-40 age. Women age \< 46 years old who plan to have egg donation. Women above 38 should test for normal ovarian function as judged by endocrinological evaluation.
  • If the couple has failed to conceive for more that 1 year, the woman should test for normal ovarian function as judged by endocrinological evaluation, and the male must have adequate sperm test.
  • Women undergoing fertility treatment or plan to have sperm donation.
  • \. Use or non use of non-steroidal treatments for excessive vaginal bleeding such as antifibrinolytic agents (e.g. Tranexamic acid) or non-steroidal anti-inflammatory drugs (e.g. Mefanamic Acid) has been maintained for the three months prior to the planned date of the study procedure and the patient has agreed to maintain this use or non-use through the 6-month follow-up period.
  • \. Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site.
  • \. Able and willing to give consent and able to attend all study visits
  • \. Able to communicate sensations during the MRgFUS procedure
  • \. Having uterine fibroids that are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
  • \. Tumor(s) are clearly visible on non-contrast MRI.
  • \. Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH

You may not qualify if:

  • \. Patient is pregnant as confirmed by pregnancy test at time of screening
  • \. Uterine size \>20 weeks as evaluated by US or MR.
  • \. Patients who are considered "high risk pregnancy" due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids.
  • \. Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable
  • \. Patients with adenomyosis
  • \. Patient is on dialysis
  • \. Hematocrit is \< 25
  • \. Patient has hemolytic anemia
  • \. Patient has unstable cardiac status including: § Unstable angina pectoris on medication§ Documented myocardial infarction within 6 months of protocol entry§ Congestive heart failure requiring medication (other than diuretic)§ Currently taking anti-arrhythmic drugs§ Severe hypertension (diastolic BP\>100 on medication)§ Presence of cardiac pacemaker
  • \. Patient has an ASA score of \>2
  • \. Patient has severe cerebrovascular disease (multiple CVA or CVA within 6 months)
  • \. Patient is on anti-coagulation therapy or has an underlying bleeding disorder
  • \. Evidence of uterine pathology other than leiomyoma
  • \. Patient has an active pelvic infection or history of pelvic inflammatory disease
  • \. Patient has an undiagnosed pelvic mass outside the uterus.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N, Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B, Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9. doi: 10.2214/ajr.183.6.01831713.

    PMID: 15547216BACKGROUND

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Wady Gedroyc

    St Mary's NHS Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations

GB(1)