uterine fibroids uterine leiomyoma
Conditions
Interventions
In MRI-guided High Intensity Focused Ultrasound (MRgHIFU), the ultrasound
generated by the transducer is focused into a small focal tissue volume at
specific target locations. During treatment, the
Sponsors
Philips
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Women, age between 18 and 59 years -Weight 40 -Cervical cell assessment by PAP: Normal, Low Grade SIL, Low risk HPV or ASCUS (Atypical Squamous Cells of Uncertain Significance) subtypes of cervical tissue -Dominant Fibroid (by diameter) >= 3 cm and
Exclusion criteria
Exclusion criteria: -Other Pelvic Disease (Other mass, endometriosis, ovarian tumour, acute pelvic disease) -Desire for future pregnancy -Significant systemic disease even if controlled (determined by intestigator or treating physician) -Positive pregnancy test -Hematocrit 50% of area) -Scar tissue or surgical clips in the direct path of the HIFU beam -MRI contraindicated -MRI contrast agent contraindicated -Fibroids not quantifiable on MRI (number & volume measurements) -Calcifications around or throughout uterine tissues -Communication Barrier
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) MR-HIFU treatment volume measurements (effectiveness) 2) HIFU minor complications and adverse events (safety) 3) Absence of unintended thermal lesions (safety) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Pain and discomfort scores (effectiveness) 2) Return to activity (effectiveness) 3) Length of hospital stay (effectiveness) 4) Quality of life and symptom scores (effectiveness) | — |
Countries
Netherlands
Outcome results
None listed