China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids - Full Text View

Purpose

The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.

Condition	Intervention
Uterine Fibroids	Device: MR-HIFU uterine fibroid treatment


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:

Change in fibroid volume [ Time Frame: At baseline and at 6 months after treatment ] [ Designated as safety issue: No ]
Proportion of patients with treated fibroid volume at 6 months after treatment reduced to 90% or less of treated fibroid volume at baseline (before MR-HIFU treatment)
Adverse Events [ Time Frame: Within 6 months after treatment ] [ Designated as safety issue: Yes ]
Number of Adverse Events reported as resulting from MR-HIFU treatment


Enrollment:	107
Study Start Date:	May 2012
Study Completion Date:	May 2015
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MR-HIFU Treatment Patients in this arm will receive MR-HIFU uterine fibroid treatment	Device: MR-HIFU uterine fibroid treatment A single treatment session for uterine fibroids with the MR-HIFU device. Other Name: Philips Sonalleve MR-HIFU

Detailed Description:

This study is to confirm the safety and effectiveness of Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women.

MR-HIFU uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to show treatment safety and effectiveness of the Philips Sonalleve MR-HIFU device for uterine fibroids marketing approval in the Chinese market. MR-HIFU will be performed in 100 patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients at baseline and at 6 months post-treatment. All patients will be followed up for 12 months post-treatment for safety.

Eligibility


Ages Eligible for Study:	18 Years to 55 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women, age between 18 and 55 years
Weight < 140 kg
Pre- or peri-menopausal
Uterine size < 24 weeks
Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
Fibroids selected for treatment meeting the following criteria:
1. Total planned ablation volume of all fibroids should not exceed 250 ml, and
2. No more than 5 fibroids should be planned for ablation, and
3. Dominant fibroid (diameter) is greater than or equal to 3 cm, and
4. Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous
5. Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU protocol) fibroids should not be treated
MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated
Willing and able to attend all study visits

Exclusion Criteria:

Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis)
Desire for future pregnancy
Significant systemic disease, even if controlled
Positive pregnancy test
Hematocrit < 25%
Extensive scarring along anterior lower abdominal wall (> 50% of area)
Surgical clips in the direct path of the HIFU beam
MRI contraindicated
MRI contrast agent contraindicated
Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)
Calcifications around or throughout uterine tissues
Communication barrier
Suspected malignancy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588899

Locations


China, Beijing
Peking University First Hospital
Beijing, Beijing, China
China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, China

Sponsors and Collaborators

Philips Healthcare

Investigators


Principal Investigator:	Qinping Liao	Peking University First Hospital
Principal Investigator:	Yueling Wang	First Affiliated Hospital Xi'an Jiaotong University

More Information


Responsible Party:	Philips Healthcare
ClinicalTrials.gov Identifier:	NCT01588899 History of Changes
Other Study ID Numbers:	907764
Study First Received:	April 27, 2012
Last Updated:	October 21, 2015
Health Authority:	China: Food and Drug Administration

Keywords provided by Philips Healthcare:


Uterine Leiomyomas Fibroids HIFU Ablation High Intensity Focused Ultrasound

Additional relevant MeSH terms:


Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue	Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 23, 2016