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

NCT ID: NCT01588899

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-05-31

Brief Summary

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.

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.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MR-HIFU Treatment

Patients in this arm will receive MR-HIFU uterine fibroid treatment

Group Type: EXPERIMENTAL

MR-HIFU uterine fibroid treatment

Intervention Type: DEVICE

A single treatment session for uterine fibroids with the MR-HIFU device.

Interventions

MR-HIFU uterine fibroid treatment

A single treatment session for uterine fibroids with the MR-HIFU device.

Intervention Type: DEVICE

Other Intervention Names

Philips Sonalleve MR-HIFU

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qinping Liao

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Yueling Wang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, , China

Countries

China

References

Chen R, Keserci B, Bi H, Han X, Wang X, Bai W, Wang Y, Yang X, Yang J, Wei J, Seppala M, Viitala A, Liao Q. The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China. J Ther Ultrasound. 2016 Nov 3;4:27. doi: 10.1186/s40349-016-0072-9. eCollection 2016.

Reference Type: DERIVED

PMID: 27822376 (View on PubMed)

Other Identifiers

907764

Identifier Type: -

Identifier Source: org_study_id