Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids

NCT ID: NCT01504308

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-03-31

Brief Summary

The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).

Detailed Description

Uterine Fibroids are the most common benign tumors in pre- and peri-menopausal women. Fibroids occur in 20-50% of women over 30 years of age, and with increasing size can produce pain, menorrhagia, pressure, bloating and urinary and bowel compression symptoms. Fibroids may also cause infertility. Symptomatic fibroids impact health and well-being of the female including lost work hours and reduced quality of life.

Current medical treatments include invasive removal of the fibroid (hysterectomy, myomectomy), drug therapy, or treatments causing necrosis of the fibroid tissue such as ablation (freezing or heating) or embolization. It has been estimated that 600,000 hysterectomies are performed per year in the United States and more than half of the conducted hysterectomies are due to fibroids. For the relief of symptoms, women wishing to preserve the uterus may choose between invasive procedures of myomectomy, Uterine Artery Embolization (UAE), ablation or cryotherapy. The surgically invasive procedures require anesthesia, hospital stays, and long recovery periods. However, High Intensity Focused Ultrasound (HIFU) shows promising results in relieving fibroid symptoms.

This study will confirm the safety and clinical effectiveness of Philips Sonalleve MR-HIFU Fibroid Therapy system for ablating symptomatic fibroids.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MR-HIFU treatment

Patients receiving MR-HIFU treatment

Group Type: EXPERIMENTAL

MR-HIFU treatment

Intervention Type: DEVICE

A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.

Sham Treatment

Patients receiving sham treatment

Group Type: SHAM_COMPARATOR

Sham treatment

Intervention Type: DEVICE

A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.

Interventions

MR-HIFU treatment

A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.

Intervention Type: DEVICE

Sham treatment

A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.

Intervention Type: DEVICE

Other Intervention Names

Philips Sonalleve MR-HIFU Uterine Fibroid Therapy; pretend treatment with Philips Sonalleve MR-HIFU

Eligibility Criteria

Inclusion Criteria

• Women, age between 18 and 50 years
• Ethnicity has a match with the intended profile for the site
• Weight < 140kg or 310lbs
• Pre- or peri-menopausal as indicated by clinical evaluation or Follicle Stimulating Hormone (FSH) level < 40 IU/L
• Willing and able to attend all study visits
• Willing and able to complete Menstrual Blood Loss (MBL) assessment with Alkaline Hematin (AH) method
• Willing and able to use reliable contraception methods
• Uterine size < 24 weeks
• Cervical cell assessment by Pap smear: Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
• MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated.
• Fibroids selected for treatment meeting the following criteria (further extrapolated in the protocol):

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. Completely non-enhancing fibroids should not be treated as the identification of treated volume becomes ambiguous

• Patient's self-assessment indicates that she has had episodes of heavy menstrual bleeding in the past 6 months.
• Menstrual Blood Loss (MBL) ≥150 ml and ≤ 500 ml

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 potential path of the HIFU beam
• MRI contraindicated
• MRI contrast agent contraindicated (including renal insufficiency)
• Calcifications around or throughout uterine tissues that may affect treatment
• Communication barrier
• Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU MR protocol) fibroids
• Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)
• Menses lasting > 7 days or intermenstrual bleeding (patient can be included if there is endometrial biopsy within 6 months to exclude malignancy)
• Patient is currently on hormonal medication for fibroids or has a hormonal medication history as described below:

1. 1-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or

2. 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement or

3. Depo Provera or equivalent: less than 6 months prior to MBL measurement

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John H Fischer II, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Episcopal Hospital, Houston, Texas, United States

Robert K Zurawin, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Episcopal Hospital, Houston, Texas, United States

Elizabeth David, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Center, Toronto, Ontario, Canada

Hyo Keun Lim, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Seoul, Republic of Korea

Aytekin Oto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago, Chicago, Illinois, United States

Amanda Yunker, D.O.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Medical Center

Peter Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Rajiv Chopra, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Chicago

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Montefiore Medical Center

The Bronx, New York, United States

Oregon Science and Health University

Portland, Oregon, United States

Vanderbilt Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Samsung Medical Center

Seoul, , South Korea

Countries

United States; Canada; South Korea

References

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Other Identifiers

G110008

Identifier Type: OTHER

Identifier Source: secondary_id

994045

Identifier Type: -

Identifier Source: org_study_id