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

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MR-HIFU uterine fibroid treatment
Sponsored by
Philips Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine Leiomyomas, Fibroids, HIFU, Ablation, High Intensity Focused Ultrasound

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR-HIFU Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Change in fibroid volume
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
Number of Adverse Events reported as resulting from MR-HIFU treatment

Secondary Outcome Measures

Full Information

First Posted
April 27, 2012
Last Updated
October 21, 2015
Sponsor
Philips Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01588899
Brief Title
China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids
Official Title
China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Uterine Leiomyomas, Fibroids, HIFU, Ablation, High Intensity Focused Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MR-HIFU Treatment
Arm Type
Experimental
Arm Description
Patients in this arm will receive MR-HIFU uterine fibroid treatment
Intervention Type
Device
Intervention Name(s)
MR-HIFU uterine fibroid treatment
Other Intervention Name(s)
Philips Sonalleve MR-HIFU
Intervention Description
A single treatment session for uterine fibroids with the MR-HIFU device.
Primary Outcome Measure Information:
Title
Change in fibroid volume
Description
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)
Time Frame
At baseline and at 6 months after treatment
Title
Adverse Events
Description
Number of Adverse Events reported as resulting from MR-HIFU treatment
Time Frame
Within 6 months after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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: Total planned ablation volume of all fibroids should not exceed 250 ml, and No more than 5 fibroids should be planned for ablation, and Dominant fibroid (diameter) is greater than or equal to 3 cm, and Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qinping Liao
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yueling Wang
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xi'an
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27822376
Citation
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.
Results Reference
derived

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

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