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NCT Number: NCT01840124

Uterine Leiomyoma Treatment With Radiofrequency Ablation

The ULTRA study is a single-arm trial of 100 premenopausal women with symptomatic uterine fibroids who undergo treatment with the Acessa device. The Acessa device is a new FDA approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to destroy fibroid tissue. The fibroids then shrink and symptoms are significantly improved. The radiofrequency energy is delivered to the fibroids during an outpatient surgical procedure. There is minimal blood loss and pain and women return to the usual activities 5-9 days after the Acessa procedure.

The investigators will evaluate changes in fibroid-related symptoms from before the Acessa treatment to 3, 6, 12, 18, 24, 30, and 36 months after Acessa treatment. The investigators will also assess operative outcomes including procedure duration, complications, blood loss, post-operative pain, and the time to return to usual activities. The investigators will determine long-term efficacy of Acessa by evaluating the rate of re-treatment for symptomatic fibroids after the Acessa procedure.

Study participants will be recruited at 5 sites within the UC Fibroid Network: UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco. UC San Francisco will serve as the Coordinating Center for the trial with oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center. A data safety and monitoring board will oversee participant safety and protection.

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Key information

Conditions

Uterine Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis, Davis, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premenopausal (at least 1 menstrual period in last 3 months)
  • Age >21years
  • Fibroids are associated with heavy bleeding, pelvic pressure or discomfort, urinary or bowel symptoms, or dyspareunia
  • Desires surgical management of fibroids
  • Uterus ≤16 weeks in size
  • All fibroids ≤ 10cm in maximum diameter by ultrasound or MRI assessment within the last year.
  • Total number of fibroids ≤6 by ultrasound or MRI assessment within the last year. (For this study "Fibroids" will be leiomyomas > 2cm)
  • Had a Pap smear within the last 3 years with appropriate follow-up and treatment for cellular abnormalities
  • Endometrial biopsy indicates no hyperplasia or cancer (biopsy only required if age >45 years and has anovulatory heavy bleeding)
  • Able to tolerate laparoscopic surgery
  • Able to give informed consent

Exclusion criteria

  • Planned treatment for infertility
  • Pedunculated fibroid with thin stalk (total stalk length is <25% maximum diameter of fibroid)
  • Intracavitary (FIGO Type 0) fibroid
  • Symptomatic fibroids are only FIGO Type 1 (submucosal with ≥ 50% intracavitary)
  • Planned concomitant surgical procedure in addition to treatment of uterine fibroids
  • Use of Essure or any other metallic, implantable device within pelvis
  • Pregnancy
  • Pelvic infection with the last 3 months
  • History of pelvic malignancy and/or pelvic radiation
  • Known or high suspicion for dense pelvic adhesions
  • Fibroids treated by myomectomy, uterine artery embolism, radio-frequency ablation, MRI Guided focused ultrasound, or cryomyolysis within the last 3 months

Treatment and study plan

Radiofrequency ablation of fibroids

Procedure

The Acessa device delivers radiofrequency energy to uterine fibroids to destroy fibroid tissue. The patient undergoes a standard laparoscopy of the pelvis. A laparoscopic ultrasound is performed to identify the precise size and location of the fibroids. The Acessa radiofrequency probe is then placed into the fibroid and the radiofrequency energy is delivered. The fibroid tissue is destroyed and the fibroid shrinks down in size to decrease fibroid-related symptoms.

Other names: Acessa

Primary outcomes

  1. Changes in fibroid-related symptoms after the Acessa procedure.

    Time frame: Baseline to 3 years.

    Changes as assessed by standard questionnaires for fibroid symptoms including menstrual pattern and flow and overall quality of life.

Secondary outcomes

  1. Re-intervention for recurrent fibroid symptoms following the Acessa procedure.

    Time frame: Baseline to 3 years

  2. Operative complications

    Time frame: Baseline to 6 weeks

    Operative complications are rare but may include excessive blood loss, uterine or pelvic infection, injury to organs adjacent to uterus such as bowel or bladder.

  3. Pregnancy after the Acessa procedure

    Time frame: Baseline to 3 years

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • University of California, Davis
  • University of California, Irvine
  • University of California, Los Angeles
  • University of California, San Diego

Registry information

Acronym: ULTRA

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2013
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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