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Spots Global Cancer Trial Database for Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

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Trial Identification

Brief Title: Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Official Title: Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Study ID: NCT02100904

Study Description

Brief Summary: 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) or myomectomy 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 fibroid procedure 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 versus myomectomy. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes. 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.

Detailed Description:

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

UC Irvine Medical Center, Irvine, California, United States

University of California, San Diego, San Diego, California, United States

University of California, San Francisco, San Francisco, California, United States

Dedicated to Women, Dover, Delaware, United States

Fibroid and Pelvic Wellness Center of Georgia, Alpharetta, Georgia, United States

Gynecology Institute of Chicago, Chicago, Illinois, United States

Women's Healthcare Associates of IL, SC, Homewood, Illinois, United States

Duke University, Durham, North Carolina, United States

Tassone Advanced Gynecology, Austin, Texas, United States

UT Southwestern, Dallas, Texas, United States

MacArthur Medical Center, Irving, Texas, United States

Acacia OBGYN, San Antonio, Texas, United States

Contact Details

Name: Vanessa Jacoby, MD

Affiliation: University of California, San Francisco

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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