We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02100904
Previous Study | Return to List | Next Study

Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry (ULTRA Registry)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02100904
First Posted: April 1, 2014
Last Update Posted: January 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose

The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF ablation (Acessa).

The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation (Acessa) within the United States. Participants will be recruited through study materials distributed at clinical offices across the country where gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the laparoscopic RF ablation (Acessa) surgery will be performed by the study participants' own gynecologist. We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes. The gynecologists performing the laparoscopic RF ablation (Acessa) surgery will be asked to consent to complete a brief study questionnaire with information on demographics, work history, professional training, and practice setting.

UC San Francisco will have 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.


Condition Intervention
Uterine Fibroids Procedure: Radiofrequency ablation of fibroids

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Changes in fibroid-related symptoms after the Acessa procedure. [ Time Frame: Baseline to 3 years ]
    We will use standard questionnaires for women with fibroids to assess changes in fibroid symptoms including menstrual pattern and flow and overall quality of life.


Secondary Outcome Measures:
  • Rate of re-intervention for recurrent fibroid symptoms following the Acessa procedure. [ Time Frame: Baseline to 6 weeks ]
  • 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.

  • Pregnancy rate after the Acessa procedure. [ Time Frame: Baseline to 3 years ]

Estimated Enrollment: 100
Study Start Date: May 2014
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women undergoing radiofrequency ablation.
All women in the trial will be in this group who receive treatment with radiofrequency ablation (Acessa).
Procedure: Radiofrequency ablation of fibroids

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with uterine fibroids who are planning to undergo or have undergone radiofrenquency ablation (Acessa) treatment.
Criteria

Inclusion Criteria:

  • Planning to undergo or have undergone RF ablation (Acessa) for treatment of uterine fibroids.
  • Able to give informed consent

Exclusion Criteria:

  • <21 years of age
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100904


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Vanessa Jacoby, MD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02100904     History of Changes
Other Study ID Numbers: 14-13325
First Submitted: March 27, 2014
First Posted: April 1, 2014
Last Update Posted: January 16, 2017
Last Verified: January 2017

Keywords provided by University of California, San Francisco:
Fibroids
Radiofrequency ablation

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases