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

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ClinicalTrials.gov Identifier: NCT01588899
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare

Tracking Information
First Submitted Date  ICMJE April 27, 2012
First Posted Date  ICMJE May 1, 2012
Last Update Posted Date October 22, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2012)
  • Change in fibroid volume [ Time Frame: At baseline and at 6 months after treatment ]
    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 ]
    Number of Adverse Events reported as resulting from MR-HIFU treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01588899 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids
Official Title  ICMJE China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uterine Fibroids
Intervention  ICMJE Device: MR-HIFU uterine fibroid treatment
A single treatment session for uterine fibroids with the MR-HIFU device.
Other Name: Philips Sonalleve MR-HIFU
Study Arms  ICMJE Experimental: MR-HIFU Treatment
Patients in this arm will receive MR-HIFU uterine fibroid treatment
Intervention: Device: MR-HIFU uterine fibroid treatment
Publications * Chen R, Keserci B, Bi H, Han X, Wang X, Bai W, Wang Y, Yang X, Yang J, Wei J, Seppälä 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. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2015)
107
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2012)
100
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01588899
Other Study ID Numbers  ICMJE 907764
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philips Healthcare
Study Sponsor  ICMJE Philips Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qinping Liao Peking University First Hospital
Principal Investigator: Yueling Wang First Affiliated Hospital Xi'an Jiaotong University
PRS Account Philips Healthcare
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP