New Clinical Trial with Focused Ultrasound and Fibroids (Europe & Asia)
Recently a new posting popped up on ClinicalTrials.gov for Focused Ultrasound and Uterine Fibroids. This study is recruiting patients (estimated at 24) in France, Germany, the Republic of Korea and the Netherlands. Elgibility and Criteria are listed below and more information can be found by clicking here.
Eligibility
| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women, age between 18 and 59 years
- Weight < 140kg
- Pre- or peri-menopausal
- Uterine size < 24 weeks
- Transformed SSS score > 40
- Normal Cervical cell assessment by PAP
- Symptomatic Fibroid disease
- Dominant fibroid greater than or equal to 3cm and less than or equal to 12 cm
Exclusion Criteria:
- Other Pelvic Disease
- Desire for future pregnancy
- Significant systemic disease even if controlled
- Positive pregnancy test
- Hematocrit < 25%
- Scarring or other interference of the HIFU beam
- MRI or contrast contraindicated
- Fibroids not quantifiable on MRI
- Calcifications around or throughout uterine tissues
- Communication barrier
Hello,
Am I eligible for this study if I live in US and willing to travel?
hello:
i am also interested in this study and am willing to travel outside of the u.s.a.
thank you,
georgia
Dear Georgia and Cassandra,
If you are willing to travel the studies will sometimes accept you, however there are certain follow up tests that will need to be done so you would have to keep in mind that you might have to travel back to that place for your follow-up visits.
The best thing to do would be to contact the specific treatment location that you are interested in traveling to, and speak with them directly about this.
If I can give you any other information please email me at info@fibroidrelief.org
Jade