NCT01588899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

2.6 years

First QC Date

April 27, 2012

Last Update Submit

October 21, 2015

Conditions

Uterine Fibroids

Keywords

Uterine LeiomyomasFibroidsHIFUAblationHigh Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (2)

  • 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)

    At baseline and at 6 months after treatment

  • Adverse Events

    Number of Adverse Events reported as resulting from MR-HIFU treatment

    Within 6 months after treatment

Study Arms (1)

MR-HIFU Treatment

EXPERIMENTAL

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

Device: MR-HIFU uterine fibroid treatment

Interventions

MR-HIFU uterine fibroid treatmentDEVICE

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

Also known as: Philips Sonalleve MR-HIFU
MR-HIFU Treatment

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

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

Xi'an, China

Location

Related Publications (1)

  • 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.

    PMID: 27822376DERIVED

MeSH Terms

Conditions

LeiomyomaMyofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective TissueConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Qinping Liao

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

  • Yueling Wang

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2012

First Posted

May 1, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

CN(2)