Clinical trial NCT02163525 - References

Symptomatic Uterine Fibroids — Post Market TRUST - U.S.A. Study

Citation(s)

•   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.
•   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.
•   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.
•   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:
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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
•   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.

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

Details for clinical trial NCT02163525