Therapeutic MRI-guided High Intensity Focused Ultrasound ablation of uterine fibroids

Phase 2

Completed

Conditions: uterine fibroids
uterine leiomyoma
10046828

Registration Number: NL-OMON33136

Lead Sponsor: Philips

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

-Women, age between 18 and 59 years
-Weight < 140kg
-Pre- or peri-menopausal (FSH < 40 mIU/ml)
-Uterine size < 24 weeks gestation
-Transformed SSS score > 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 <= 12 cm

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 < 25%
-Extensive scarring along anterior lower abdominal wall (>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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) MR-HIFU treatment volume measurements (effectiveness)<br /><br>2) HIFU minor complications and adverse events (safety)<br /><br>3) Absence of unintended thermal lesions (safety)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Pain and discomfort scores (effectiveness)<br /><br>2) Return to activity (effectiveness)<br /><br>3) Length of hospital stay (effectiveness)<br /><br>4) Quality of life and symptom scores (effectiveness)</p><br>