Clinical trial NCT02163525: Post Market TRUST - U.S.A. Study
Official title: The TRUST (Treatment Results of Uterine Sparing Technologies) U.S.A. Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Symptomatic Uterine Fibroids
Keywords: Fibroids
Myomas
leiomyomata
menorrhagia
Acessa Procedure
Radiofrequency Ablation (RFA)
GFA
Acessa
Lead sponsor: Acessa Health, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-13
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Are not willing to be randomized to treatment.

Primary outcomes:
measure: Compare direct cost of GFA compared to those of myomectomy and UAE
timeFrame: 3 months post procedure
measure: Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study.
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Assess the incidence and cost of post discharge procedure-related complications and reinterventions
timeFrame: 60 months
measure: Assess factors that influence indirect costs of the three treatment alternatives
timeFrame: 60 months
measure: Assess Uterine Fibroid Symptom Severity and Quality of Life (UFS-QoL) pre-treatment to post treatment in all treatment groups
timeFrame: 60 months
measure: Assess subjects menstrual bleeding using the MIQ
timeFrame: 60 months
measure: Assess subject's satisfaction with her treatment
timeFrame: 12 months
measure: Assess the subject's general health outcome
timeFrame: 60 months post procedure
measure: Assess the incidence of serious complications per investigator-surgeon during training and post training.
timeFrame: 60 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: University of California, Los Angeles
state: California
city: Walnut Creek
country: United States
facility: Aspen Surgery Center/John Muir Hospital
state: California
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medicine and Biological Sciences
state: Illinois
city: Jamaica Plain
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: West Bloomfield
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Austin
country: United States
facility: Texas Fertility Center
state: Texas
city: Falls Church
country: United States
facility: INOVA
state: Virginia
Study officials:
affiliation: Henry Ford Hospital
name: David Eisenstein, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Macer JA. For uterine-sparing fibroid treatment, consider laparoscopic ultrasound-guided radiofrequency ablation. obmanagement.com Vol 25 No. 11 November 2013
citation: 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.
citation: 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.
citation: 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.
citation: 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.