AzTrials
AzTrials

Symptomatic Uterine FibroidsNCT02163525

Post Market TRUST - U.S.A. Study

A study testing Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy and Uterine Artery Embolization (UAE) in people with Symptomatic Uterine Fibroids, run by Acessa Health, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Symptomatic Uterine Fibroids
What is being tested?
Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy and Uterine Artery Embolization (UAE)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
9 sitesUnited States
Study dates
12 Jun 2014to 12 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are ≥ 18 years old and menstruating
  • Have symptomatic uterine fibroids
  • Have a uterine size ≤ 16 gestational weeks as determined by pelvic exam
  • Have all fibroids that are less than 10 cm in any diameter
  • Desire uterine conservation
  • Have had a normal Pap smear within the past 36 months defined as "no untreated cervical malignancy or dysplasia."
  • Are willing and able to comply with all study tests, procedures, and assessment tools
  • Are capable of providing informed consent.

Who cannot join

  • Have contraindications for laparoscopic surgery and/or general anesthesia.
  • Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
  • Patients requiring major elective concomitant procedures (e.g., hernia repair)
  • Are pregnant or lactating
  • Have taken any depot gonadotropin releasing hormone (GnRh) agonist within three months prior to the screening procedures
  • Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least 10 days prior to treatment
Show all 16Show fewer
  • Have chronic pelvic pain known to not be due to uterine fibroids
  • Have known or suspected endometriosis Stage 3 or 4, adenomyosis
  • Have active or history of pelvic inflammatory disease
  • Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the past five years
  • Have had pelvic radiation
  • Have a non-uterine pelvic mass over 3 cm
  • Have a cervical myoma
  • Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1 submucous fibroids that are better treated via hysteroscopic methods
  • In the medical judgment of the investigator should not participate in the study
  • Are not willing to be randomized to treatment.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Augusta University

    Augusta, Georgia, 30912-3360

  • Texas Fertility Center

    Austin, Texas, 78731

  • University of Chicago Medicine and Biological Sciences

    Chicago, Illinois, 60637

  • INOVA

    Falls Church, Virginia, 60637

  • Brigham and Women's Hospital

    Jamaica Plain, Massachusetts, 02130

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California, Los Angeles

    Santa Monica, California, 90401

  • Aspen Surgery Center/John Muir Hospital

    Walnut Creek, California, 94598

  • Henry Ford Hospital

    West Bloomfield, Michigan, 48322

Other trials in United States

About this study

Official title: The TRUST (Treatment Results of Uterine Sparing Technologies) U.S.A. Study

This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids. In addition, data from this study is being used to satisfy the requirements of the United States Food and Drug Administration's 522 (post market surveillance) order.

Read the detailed description

The purpose of this study is to 1) evaluate the economic burden, safety and outcomes of three uterine-conserving treatment alternatives for symptomatic uterine fibroids: myomectomy, uterine artery embolization (UAE), and global fibroid ablation (GFA) using the Acessa™ System, and 2) meet the requirements of the U.S. Food and Drug Administration's 522 Order for post market surveillance In this study, subjects who have symptomatic uterine fibroids will be randomized to one of three uterine-conserving treatments based on the local standard of care.

Being tested
Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
Keywords
Fibroids, Myomas, leiomyomata, menorrhagia, Acessa Procedure, Radiofrequency Ablation (RFA), GFA, Acessa
Medical subject headings
Leiomyoma, Myoma, Menorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Global Fibroid Ablation (GFA)Procedure or surgery

    Also called GFA, Radiofrequency ablation, RFA, Radiofrequency volumetric fibroid ablation

    GFA is radiofrequency ablation of fibroids. This is a laparoscopic procedure whereby a radiofrequency probe is inserted into the fibroid under laparoscopic and ultrasound guidance. Each fibroid is heated to temperatures averaging 95 deg C. The fibroid undergoes coagulative necrosis and shrinks and/or disappears.

  • Abdominal or Laparoscopic MyomectomyProcedure or surgery

    Also called Myomectomy

    Myomectomy is a procedure in which an incision is made into the uterus and the fibroids are surgically removed from the uterus. The uterine incision is closed with sutures. This procedure can be performed through an abdominal incision or via laparoscopy.

  • Uterine Artery Embolization (UAE)Procedure or surgery

    Also called UAE, Uterine Fibroid Embolization, UFE

    UAE is a minimally invasive surgical procedure used to treat uterine fibroids. An embolic material is injected into the uterine artery(ies) to block blood flow to one or more fibroids. This procedure is performed by an interventional radiologist.

Study groups in NCT02163525
Study groupRoleWhat they receive
Ablation vs EmbolizationActive comparatorWomen are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)
Receives: Procedure: Global Fibroid Ablation (GFA); Procedure: Uterine Artery Embolization (UAE)
Ablation vs MyomectomyActive comparatorWomen are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)
Receives: Procedure: Global Fibroid Ablation (GFA); Procedure: Abdominal or Laparoscopic Myomectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare direct cost of GFA compared to those of myomectomy and UAE

    To compare medical, surgical, and hospitalization costs (including procedural complication costs) of Global Fibroid Ablation (GFA) compared to those of Myomectomy and Uterine Artery Embolization (UAE)at 3 months post procedure.

    Measured: 3 months post procedure

  2. Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study.

    Overall rates of acute (within 48 hours post procedure) and near-term (between 2 and 30 days post procedure) serious complications in all GFA subjects compared to the acute and near-term treatment-related serious adverse event rates in the pivotal study.

    Measured: 30 days post procedure

Secondary outcomes (7)

  1. Assess the incidence and cost of post discharge procedure-related complications and reinterventions

    Safety measures will be assessed by comparing the complication and reintervention rate for all three alternatives (GFA, Myomectomy, UAE).

    Measured: 60 months

  2. Assess factors that influence indirect costs of the three treatment alternatives

    Compare incidence costs of post discharge procedure-related complications and re-interventions we well as indirect cost factors defined as days to return-to-work, return to normal activities of daily living, and cost of care up to 60 months post discharge.

    Measured: 60 months

  3. Assess Uterine Fibroid Symptom Severity and Quality of Life (UFS-QoL) pre-treatment to post treatment in all treatment groups

    To compare fibroid symptom severity and quality of life scores at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool.

    Measured: 60 months

  4. Assess subjects menstrual bleeding using the MIQ

    Compare subjects menstrual bleeding pre-treatment and up to 3, 6, 12, 24, 36, 48, and 60 months post treatment using the Menorrhagia Impact Questionnaire (MIQ).

    Measured: 60 months

  5. Assess subject's satisfaction with her treatment

    Assess the subject's satisfaction with her assigned procedure at 12 months post procedure using the Overall Treatment Effect questionnaire

    Measured: 12 months

  6. Assess the subject's general health outcome

    General health outcome evaluation at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the EuroQol (EQ-5D), a standardized instrument for use as a measure of health outcome

    Measured: 60 months post procedure

  7. Assess the incidence of serious complications per investigator-surgeon during training and post training.

    The incidence of acute and near-term serious complications following the GFA cases will also be analyzed by investigator-surgeon during the training and post training periods..

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2014 (estimated)
  2. Study start12 Jun 2014
  3. Primary completionJul 2019
  4. Study completion12 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02163525
Sponsor's protocol ID
CP-00-0025
Status last verified
Sep 2025
First submitted
11 Jun 2014
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.

    PubMed 11814511

  • Viswanathan M, Hartmann K, McKoy N, Stuart G, Rankins N, Thieda P, Lux LJ, Lohr KN. Management of uterine fibroids: an update of the evidence. Evid Rep Technol Assess (Full Rep). 2007 Jul;(154):1-122.

    PubMed 18288885

  • Twijnstra AR, Kolkman W, Trimbos-Kemper GC, Jansen FW. Implementation of advanced laparoscopic surgery in gynecology: national overview of trends. J Minim Invasive Gynecol. 2010 Jul-Aug;17(4):487-92. doi: 10.1016/j.jmig.2010.03.010. Epub 2010 May 14.

    PubMed 20471917

  • Holzer A, Jirecek ST, Illievich UM, Huber J, Wenzl RJ. Laparoscopic versus open myomectomy: a double-blind study to evaluate postoperative pain. Anesth Analg. 2006 May;102(5):1480-4. doi: 10.1213/01.ane.0000204321.85599.0d.

    PubMed 16632830

  • Parker WH, Iacampo K, Long T. Uterine rupture after laparoscopic removal of a pedunculated myoma. J Minim Invasive Gynecol. 2007 May-Jun;14(3):362-4. doi: 10.1016/j.jmig.2006.10.024.

    PubMed 17478371

  • Banas T, Klimek M, Fugiel A, Skotniczny K. Spontaneous uterine rupture at 35 weeks' gestation, 3 years after laparoscopic myomectomy, without signs of fetal distress. J Obstet Gynaecol Res. 2005 Dec;31(6):527-30. doi: 10.1111/j.1447-0756.2005.00331.x.

    PubMed 16343253

  • Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD, Wu O, Craig LE, Lumsden MA. Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results. BJOG. 2011 Jul;118(8):936-44. doi: 10.1111/j.1471-0528.2011.02952.x. Epub 2011 Apr 12.

    PubMed 21481151

  • Mara M, Maskova J, Fucikova Z, Kuzel D, Belsan T, Sosna O. Midterm clinical and first reproductive results of a randomized controlled trial comparing uterine fibroid embolization and myomectomy. Cardiovasc Intervent Radiol. 2008 Jan-Feb;31(1):73-85. doi: 10.1007/s00270-007-9195-2. Epub 2007 Oct 18.

    PubMed 17943348

  • Manyonda IT, Bratby M, Horst JS, Banu N, Gorti M, Belli AM. Uterine artery embolization versus myomectomy: impact on quality of life--results of the FUME (Fibroids of the Uterus: Myomectomy versus Embolization) Trial. Cardiovasc Intervent Radiol. 2012 Jun;35(3):530-6. doi: 10.1007/s00270-011-0228-5. Epub 2011 Jul 20.

    PubMed 21773858

  • Carls GS, Lee DW, Ozminkowski RJ, Wang S, Gibson TB, Stewart E. What are the total costs of surgical treatment for uterine fibroids? J Womens Health (Larchmt). 2008 Sep;17(7):1119-32. doi: 10.1089/jwh.2008.0456.

    PubMed 18687032

  • Nash K, Feinglass J, Zei C, Lu G, Mengesha B, Lewicky-Gaupp C, Lin A. Robotic-assisted laparoscopic myomectomy versus abdominal myomectomy: a comparative analysis of surgical outcomes and costs. Arch Gynecol Obstet. 2012 Feb;285(2):435-40. doi: 10.1007/s00404-011-1999-2. Epub 2011 Jul 22.

    PubMed 21779774

  • Al-Fozan H, Dufort J, Kaplow M, Valenti D, Tulandi T. Cost analysis of myomectomy, hysterectomy, and uterine artery embolization. Am J Obstet Gynecol. 2002 Nov;187(5):1401-4. doi: 10.1067/mob.2002.127374.

    PubMed 12439538

  • Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Curr Med Res Opin. 2010 Dec;26(12):2745-55. doi: 10.1185/03007995.2010.532200. Epub 2010 Nov 3.

    PubMed 21043553

  • Hartung J, Knapp G. On tests of the overall treatment effect in meta-analysis with normally distributed responses. Stat Med. 2001 Jun 30;20(12):1771-82. doi: 10.1002/sim.791.

    PubMed 11406840

  • Chudnoff SG, Berman JM, Levine DJ, Harris M, Guido RS, Banks E. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol. 2013 May;121(5):1075-1082. doi: 10.1097/AOG.0b013e31828b7962.

    PubMed 23635746

Questions about this trial

What is this clinical trial studying?

A study testing Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy and Uterine Artery Embolization (UAE) in people with Symptomatic Uterine Fibroids, run by Acessa Health, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare direct cost of GFA compared to those of myomectomy and UAE (time frame: 3 months post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02163525, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.

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