Uterine FibroidsPhase 4NCT00180739
Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future
A Phase 4 study testing Magnetic Resonance Guided Focused Ultrasound in people with Uterine Fibroids and Pregnancy, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids, Pregnancy
- What is being tested?
- Magnetic Resonance Guided Focused Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2004to Aug 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. 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.
- 2. 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.
- 3. Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site.
- 4. Able and willing to give consent and able to attend all study visits
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- 5. Able to communicate sensations during the MRgFUS procedure
- 6. 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).
- 7. Tumor(s) are clearly visible on non-contrast MRI.
- 8. Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH
Who cannot join
- 1. Patient is pregnant as confirmed by pregnancy test at time of screening
- 2. Uterine size >20 weeks as evaluated by US or MR.
- 3. Patients who are considered "high risk pregnancy" due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids.
- 4. Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable
- 5. Patients with adenomyosis
- 6. Patient is on dialysis
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- 7. Hematocrit is < 25
- 8. Patient has hemolytic anemia
- 9. 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
- 10. Patient has an ASA score of >2
- 11. Patient has severe cerebrovascular disease (multiple CVA or CVA within 6 months)
- 12. Patient is on anti-coagulation therapy or has an underlying bleeding disorder
- 13. Evidence of uterine pathology other than leiomyoma
- 14. Patient has an active pelvic infection or history of pelvic inflammatory disease
- 15. Patient has an undiagnosed pelvic mass outside the uterus.
- 16. Patient weight >110 kg
- 17. Subject with extensive abdominal scarring in an area of the abdomen directly anterior to the treatment area.
- 18. Subject with standard contraindications for MR imaging such as non-MRI compatable implanted metallic devices.
- 19. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist).
- 20. Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hours.)
- 21. Patient with an intrauterine contraceptive device anywhere in the treatment beam path.
- 22. Women who are breast feeding.
- 23. Five or more fibroids, bigger then 3cm diameter, each
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids in Women Desiring Future Pregnancies
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.
- Conditions
- Uterine Fibroids, Pregnancy
- Being tested
- Magnetic Resonance Guided Focused Ultrasound
- Keywords
- MR guided FUS, Uterine Fibroids, Fertility, Pregnancy
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Guided Focused UltrasoundProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcomes in women who have received treatment with MRgFUS
Secondary outcomes (1)
Efficacy of MRgFUS as judged by HRQOL questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionAug 2005
- Study completionAug 2005
Why it stopped: Recruitment not possible worldwide
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- InSightec
- Responsible party
- Sponsor
- Investigators
- Wady Gedroyc, Principal investigator, St Mary's NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180739
- Sponsor's protocol ID
- UF004
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2005
- Last updated
- 24 Oct 2023
- Results posted
- No
Publications
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.
PubMed 15547216
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids in Women Desiring Future Pregnancies
- ClinicalTrials.gov ID
- NCT00180739
- Acronym / sponsor ID
- UF004
- Conditions
- Uterine Fibroids, Pregnancy
- Keywords
- MR guided FUS, Uterine Fibroids, Fertility, Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment not possible worldwide
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- InSightec
- Study start
- Apr 2004 (actual)
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 1. 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.
- 2. 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.
- 3. Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site.
Key exclusion criteria (23 listed)
- 1. Patient is pregnant as confirmed by pregnancy test at time of screening
- 2. Uterine size >20 weeks as evaluated by US or MR.
- 3. Patients who are considered "high risk pregnancy" due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids.
- 4. Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable
- 5. Patients with adenomyosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Guided Focused Ultrasound | Procedure or surgery | – |
Primary outcome
Pregnancy outcomes in women who have received treatment with MRgFUS
1 secondary outcome
Efficacy of MRgFUS as judged by HRQOL questionnaires
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Background: PubMed 15547216Hindley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wady Gedroyc principal investigator
St Mary's NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnetic Resonance Guided Focused Ultrasound in people with Uterine Fibroids and Pregnancy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy outcomes in women who have received treatment with MRgFUS. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00180739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.