Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
This is a multi-center randomized parallel controlled two-arm phase iii trial evaluating the safety and clinical effectiveness of the Philips Sonalleve MR-HiFu Fibroid Therapy system in the treatment of symptomatic uterine fibroid patients. one arm of patients will receive HiFu treatment for their fibroids, the other arm will receive a Sham treatment. The ratio of HiFu:Sham treatments is 4:1, and the assignment will be random. Patients will be followed for 12 months to evaluate the primary endpoints for the pivotal trial, and 36 additional months for the follow-up/post-market surveillance.
Patients will be asked whether they consent to their data being collected in this study to be transferred to the ReLieF registry. The ReLieF Registry is a 3-year, observational, prospective, global registry. it is a collaborative effort by the sponsors and other manufacturers of HiFu technology to provide large scale evidence on the safety and long term effectiveness of HiFu for the indication of symptomatic uterine fibroids that could be used for worldwide clinical adoption and economic coverage of this procedure. This will be an [Quote]opt-in[Quote] in the consent forms.
There will also be a small number of subjects (approximately 5) enrolled for initial imaging protocol optimization prior to starting the pivotal study. These subjects will be healthy volunteers, and they will not receive any HiFu treatment or follow-up. They will serve to help set up the imaging and treatment planning protocols required for the HiFu treatments. a separate consent form for this aspect of imaging protocol development will be part of the submission.
The primary endpoints being evaluated in this study are 1) the number of patients seeking alternative interventional treatments (aiT) and 2) reduction in menstrual blood flow (defined as a 50% reduction or to a level below 80/ml/cycle) over a 12 month follow-up period after treatment. These endpoints are meant to evaluate quantitatively the clinical effectiveness of the Philips Sonalleve MR-HiFu Fibroid Therapy System. it is anticipated that at least 85% of women receiving the HiFu treatment will experience symptom relief and a reduction in menstrual blood flow. it is anticipated all women receiving the Sham treatment will not experience any relief of symptoms or reduction in blood flow.
The secondary endpoints being evaluated in this trial include 1) The change in quality of life of subjects treated with MR-HiFu 12 months following treatment using the Symptom Severity Score (SSS) and uterine Fibroid Symptom and Quality of Life (uFS-QoL), and 2) The time to return to normal activities after MR-HiFu treatment
- Women, age between 18 and 50 years
- Ethnicity has a match with the intended profile for the site
- Weight < 140kg or 310lbs
- Pre- or peri-menopausal as indicated by clinical evaluation or FSH < 40 IU/L
- Willing and able to attend all study visits
- Willing and able to complete MBL assessment with AH method
- Willing and able to use reliable contraception methods
- Uterine size < 24 weeks
- Cervical cell assessment by PAP: Normal, Low Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue
- MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated (evaluated on a screening MRI).
- Fibroids selected for treatment meeting the following criteria (evaluated on a screening MRI): 1) Total planned ablation volume of all fibroids should not exceed 250 ml, 2) No more than 5 fibroids should be planned for ablation, 3) Dominant fibroid (diameter) is greater than or equal to 3 cm and 4) Completely non-enhancing fibroids should not be treated as the identification of treated volume becomes ambiguous
- Patient[Single Quote]s self-assessment indicates that she has had episodes of heavy menstrual bleeding of at least 3 months within the past 6 months.
-If the woman is not currently taking any hormonal contraceptives, she has been off all hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through the 12 months of follow-up
If the woman is currently taking hormonal contraceptives, she has taken hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through 12 months of follow up.
- Menstrual Blood Loss (MBL) >=150 ml and <= 500 ml, evaluated using the Alkaline hematin test (AHT)