Post Market TRUST - U.S.A. Study

NCT02163525 | Completed DMC

• 1 other identifier: CP-00-0025
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Symptomatic Uterine Fibroids

Keywords

Fibroids; Myomas; leiomyomata; menorrhagia; Acessa Procedure; Radiofrequency Ablation (RFA); GFA; Acessa

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months post procedure

• 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.

  30 days post procedure

Secondary Outcomes (7)

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

  60 months

• Assess factors that influence indirect costs of the three treatment alternatives

  60 months

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

  60 months

• Assess subjects menstrual bleeding using the MIQ

  60 months

• Assess subject's satisfaction with her treatment

  12 months

Study Arms (2)

Ablation vs Embolization

ACTIVE COMPARATOR

Women are randomized 1:1 to either global fibroid ablation (GFA) or uterine artery embolization (UAE)

Procedure: Global Fibroid Ablation (GFA); Procedure: Uterine Artery Embolization (UAE)

Ablation vs Myomectomy

ACTIVE COMPARATOR

Women are randomized 1:1 to either global fibroid ablation (GFA) or myomectomy (laparoscopic or abdominal)

Procedure: Global Fibroid Ablation (GFA); Procedure: Abdominal or Laparoscopic Myomectomy

Interventions

Global Fibroid Ablation (GFA) PROCEDURE

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.

Also known as: GFA, Radiofrequency ablation, RFA, Radiofrequency volumetric fibroid ablation, Acessa procedure, Acessa treatment

Ablation vs Embolization; Ablation vs Myomectomy

Abdominal or Laparoscopic Myomectomy PROCEDURE

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.

Also known as: Myomectomy

Ablation vs Myomectomy

Uterine Artery Embolization (UAE) PROCEDURE

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.

Also known as: UAE, Uterine Fibroid Embolization, UFE

Ablation vs Embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Acessa Health, Inc.: lead

Study Sites (9)

University of California, Los Angeles

Santa Monica, California, 90401, United States

Location

Aspen Surgery Center/John Muir Hospital

Walnut Creek, California, 94598, United States

Location

Augusta University

Augusta, Georgia, 30912-3360, United States

Location

University of Chicago Medicine and Biological Sciences

Chicago, Illinois, 60637, United States

Location

Brigham and Women's Hospital

Jamaica Plain, Massachusetts, 02130, United States

Location

Henry Ford Hospital

West Bloomfield, Michigan, 48322, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Texas Fertility Center

Austin, Texas, 78731, United States

Location

INOVA

Falls Church, Virginia, 60637, United States

Location

Related Publications (23)

• 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.

  PMID: 11814511 BACKGROUND

• 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.

  PMID: 18288885 BACKGROUND

• 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.

  PMID: 20471917 BACKGROUND

• 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.

  PMID: 16632830 BACKGROUND

• 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.

  PMID: 17478371 BACKGROUND

• 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.

  PMID: 16343253 BACKGROUND

• 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.

  PMID: 21481151 BACKGROUND

• 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.

  PMID: 17943348 BACKGROUND

• 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.

  PMID: 21773858 BACKGROUND

• 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.

  PMID: 18687032 BACKGROUND

• 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.

  PMID: 21779774 BACKGROUND

• 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.

  PMID: 12439538 BACKGROUND

• 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.

  PMID: 21043553 BACKGROUND

• 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.

  PMID: 11406840 BACKGROUND

• 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.

  PMID: 23635746 BACKGROUND

• Robles R, Aguirre VA, Argueta AI, Guerrero MR. Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up. Int J Gynaecol Obstet. 2013 Jan;120(1):65-9. doi: 10.1016/j.ijgo.2012.07.023. Epub 2012 Oct 14.

  PMID: 23073229 BACKGROUND

• Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Lee BB. Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System. J Minim Invasive Gynecol. 2011 May-Jun;18(3):364-71. doi: 10.1016/j.jmig.2011.02.006.

  PMID: 21545960 BACKGROUND

• Guido RS, Macer JA, Abbott K, Falls JL, Tilley IB, Chudnoff SG. Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years' outcome from the Halt trial. Health Qual Life Outcomes. 2013 Aug 13;11:139. doi: 10.1186/1477-7525-11-139.

  PMID: 23941588 BACKGROUND

• Macer JA. For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation. obmanagement.com Vol 25 No. 11 November 2013

  BACKGROUND

• Berman JM, Guido RS, Garza Leal JG, Pemueller RR, Whaley FS, Chudnoff SG; Halt Study Group. Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas. J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):767-74. doi: 10.1016/j.jmig.2014.02.015. Epub 2014 Mar 5.

  PMID: 24613404 BACKGROUND

• Yu S, Silverberg K, Bhagavath B, Shobeiri SA, Propst A, Eisenstein D. Post-Market Safety of Laparoscopic Ultrasound-Guided Radiofrequency Ablation. JSLS. 2020 Oct-Dec;24(4):e2020.00050. doi: 10.4293/JSLS.2020.00050.

  PMID: 33510567 RESULT

• Braun KM, Sheridan M, Latif EZ, Regush L, Maksymowicz A, Weins L, Bedaiwy MA, Tyson N, Davidson MJ, Sanders BH. Surgeons' early experience with the Acessa procedure: gaining proficiency with new technology. Int J Womens Health. 2016 Nov 23;8:669-675. doi: 10.2147/IJWH.S119265. eCollection 2016.

  PMID: 27920582 RESULT

• Yu S, Bhagavath B, Shobeiri SA, Eisenstein D, Levy B. Clinical and Patient Reported Outcomes of Pre- and Postsurgical Treatment of Symptomatic Uterine Leiomyomas: A 12-Month Follow-up Review of TRUST, a Surgical Randomized Clinical Trial Comparing Laparoscopic Radiofrequency Ablation and Myomectomy. J Minim Invasive Gynecol. 2022 Jun;29(6):726-737. doi: 10.1016/j.jmig.2022.01.009. Epub 2022 Jan 24.

  PMID: 35085837 RESULT

MeSH Terms

Conditions

Leiomyoma; Myoma; Menorrhagia

Interventions

Radiofrequency Ablation; Uterine Myomectomy; Uterine Artery Embolization

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Embolization, Therapeutic; Hemostatic Techniques; Therapeutic Occlusion

Study Officials

• David Eisenstein, MD

  Henry Ford Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: June 12, 2014
• Primary Completion: July 1, 2019
• Study Completion: September 12, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (9)