Post Market TRUST - U.S.A. Study

Symptomatic Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02163525
• Other study ID #: CP-00-0025
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2014
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Acessa Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: June 2024
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Symptomatic Uterine Fibroids

Intervention

Procedure:
• Global Fibroid Ablation (GFA)
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 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)
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.

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia
United States	Texas Fertility Center	Austin	Texas
United States	University of Chicago Medicine and Biological Sciences	Chicago	Illinois
United States	INOVA	Falls Church	Virginia
United States	Brigham and Women's Hospital	Jamaica Plain	Massachusetts
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California, Los Angeles	Santa Monica	California
United States	Aspen Surgery Center/John Muir Hospital	Walnut Creek	California
United States	Henry Ford Hospital	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Acessa Health, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (23)

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. — View 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. — View 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. — View 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: — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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 Laparos — View 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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	60 months
Secondary	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.	60 months
Secondary	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.	60 months
Secondary	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).	60 months
Secondary	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	12 months
Secondary	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	60 months post procedure
Secondary	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..	60 months