NCT01239641

Brief Summary

The purpose of this study is to determine whether HIFU has superiority over traditional surgery on satisfaction and adverse impact.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 15, 2010

Status Verified

November 1, 2010

Enrollment Period

2.3 years

First QC Date

November 10, 2010

Last Update Submit

November 12, 2010

Conditions

Uterine Fibroid

Keywords

Uterine FibroidsMyoectomyHigh Intensity Focused Ultrasoundablation

Outcome Measures

Primary Outcomes (1)

  • The quality of life, adverse events

    1 year

Secondary Outcomes (1)

  • Fibroid volume ablated

    any time

Interventions

High intensity focused ultrasoundPROCEDURE

The term 'high intensity focused ultrasound' means using ultrasound to causes coagulation necrosis to destroy the targeted tissue, in this case, uterine fibroids.

Also known as: myomectomy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 45; The size of fibroid situated at anterior wall not lower than 2 cm in MRI feature; The size of fibroid situated at posterior wall not lower than 4 cm in MRI feature.

You may not qualify if:

  • Cervical fibroids; Subserosal fibroids with pedicle, the width of pedicle≤ 2cm; Type 0 submucosal fibroids according to European Gynecologic Endoscopy classification; Combined with acute reproductive inflammation, or other benign and malignant gynecological diseases such as endometriosis, ovarian cancer; Pregnant (pregnancy test is positive), and lactating women; Allergy to MRI contrast agent; The history of collagen connective tissue, radiotherapy, especially abdominal radiotherapy; Surgical and anesthetic contraindications such as serious cardiac, vascular and other systemic diseases; Poor compliance; Patients who are not subject to experimental design.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 1st Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Related Publications (1)

  • Wang X, Qin J, Wang L, Chen J, Chen W, Tang L. Effect of high-intensity focused ultrasound on sexual function in the treatment of uterine fibroids: comparison to conventional myomectomy. Arch Gynecol Obstet. 2013 Oct;288(4):851-8. doi: 10.1007/s00404-013-2775-2. Epub 2013 Apr 7.

    PMID: 23564052DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

Uterine Myomectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • LD Tang, PhD

    the first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecolog

    STUDY CHAIR

  • Z B wang, PhD

    Biomedical Engineering Department of Chongqing Medical University

    STUDY DIRECTOR

  • Wen-Zhi Chen, MD

    Clinical Center for Tumor Therapy, the 2nd Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

  • Jin-Yun Chen, PhD

    Biomedical Engineering Department of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

  • Min Zhou, PhD

    The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

  • Juan Qin, PhD

    Biomedical Engineering Department, Chongqing Medical University

    PRINCIPAL INVESTIGATOR

  • Xiaoyan Wang, PhD

    The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 11, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

November 15, 2010

Record last verified: 2010-11

Locations

CN(1)