In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

NCT05604001 | Completed

• 1 other identifier: LaMyA
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 4

Brief Summary

To evaluate feasibility and efficacy of in-office hysteroscopic ablation of submucous uterine fibroid using diode laser

Conditions

Laser Hysteroscopic Ablation of Submucous Myoma

Outcome Measures

Primary Outcomes (1)

• Bleeding

  improvement of the heavy menstrual bleeding

  before the procedure and at 3 months follow up visit

Secondary Outcomes (2)

• fibroid volume reduction

  before the procedure and at 3 months follow up visit

• changes on the myoma vascularity

  before the procedure and at 3 months follow up visit

Study Arms (1)

Symptomatic submucosal myoma

EXPERIMENTAL

patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy with laser ablation of the myoma.

Device: hysteroscopic ablation of submucous uterine fibroid using diode laser

Interventions

hysteroscopic ablation of submucous uterine fibroid using diode laser DEVICE

patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy and laser ablation of the myoma

Symptomatic submucosal myoma

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: fiborid is a pathology that affects women´s uterus
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• symptomatic patients without desire of future fertility (symptoms included heavy menstrual bleeding, abdominal discomfort, bulk symptoms such as urinary frequency, pelvic pressure and constipation),
• grade 0-2 (FIGO classification) ≤ 7cm fibroids with evident vascularity seen by 3D-DS compared to its adjacent myometrial tissue

You may not qualify if:

• intramural fibroids (FIGO class 3 or more),
• \>2 submucosal fibroids,
• pelvic inflammatory disease,
• known gynecologic malignancy,
• severe cervical stenosis,
• pregnancy
• desire of future fertility,
• previous cervical surgery

Sponsors & Collaborators

• Ariel University: lead

Study Sites (4)

Laniado University Hospital

Netanya, Israel

Location

University of Cagliari

Cagliari, Italy

Location

universita della campagna luigi Vanvitelli

Napoli, Italy

Location

Parc de Salut Mar

Barcelona, 08003, Spain

Location

Related Publications (23)

• Carranza-Mamane B, Havelock J, Hemmings R; REPRODUCTIVE ENDOCRINOLOGY AND INFERTILITY COMMITTEE; SPECIAL CONTRIBUTOR. The management of uterine fibroids in women with otherwise unexplained infertility. J Obstet Gynaecol Can. 2015 Mar;37(3):277-285. doi: 10.1016/S1701-2163(15)30318-2.

  PMID: 26001875 BACKGROUND

• Valentine LN, Bradley LD. Hysteroscopy for Abnormal Uterine Bleeding and Fibroids. Clin Obstet Gynecol. 2017 Jun;60(2):231-244. doi: 10.1097/GRF.0000000000000287.

  PMID: 28406809 BACKGROUND

• Capmas P, Levaillant JM, Fernandez H. Surgical techniques and outcome in the management of submucous fibroids. Curr Opin Obstet Gynecol. 2013 Aug;25(4):332-8. doi: 10.1097/GCO.0b013e3283630e10.

  PMID: 23812380 BACKGROUND

• Yendru KS, Yelamanchi SD, Vaddiraju GB. Hysteroscopic Resection of Submucous Fibroids in Symptomatic Women. J Obstet Gynaecol India. 2019 Apr;69(2):166-172. doi: 10.1007/s13224-018-1139-z. Epub 2018 May 31.

  PMID: 30956472 BACKGROUND

• Vitale SG, Lagana AS, Caruso S, Garzon S, Vecchio GM, La Rosa VL, Casarin J, Ghezzi F. Comparison of three biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal patients (HYGREB-1): A multicenter, single-blind randomized clinical trial. Int J Gynaecol Obstet. 2021 Dec;155(3):425-432. doi: 10.1002/ijgo.13669. Epub 2021 Apr 4.

  PMID: 33686708 BACKGROUND

• Nappi L, Pontis A, Sorrentino F, Greco P, Angioni S. Hysteroscopic metroplasty for the septate uterus with diode laser: a pilot study. Eur J Obstet Gynecol Reprod Biol. 2016 Nov;206:32-35. doi: 10.1016/j.ejogrb.2016.08.035. Epub 2016 Aug 31.

  PMID: 27632410 BACKGROUND

• Haimovich S, Lopez-Yarto M, Urresta Avila J, Saavedra Tascon A, Hernandez JL, Carreras Collado R. Office Hysteroscopic Laser Enucleation of Submucous Myomas without Mass Extraction: A Case Series Study. Biomed Res Int. 2015;2015:905204. doi: 10.1155/2015/905204. Epub 2015 May 18.

  PMID: 26090457 BACKGROUND

• Goldfarb HA. Laparoscopic coagulation of myoma (myolysis). Obstet Gynecol Clin North Am. 1995 Dec;22(4):807-19. No abstract available.

  PMID: 8786884 BACKGROUND

• Donnez J, Squifflet J, Polet R, Nisolle M. Laparoscopic myolysis. Hum Reprod Update. 2000 Nov-Dec;6(6):609-13. doi: 10.1093/humupd/6.6.609.

  PMID: 11129695 BACKGROUND

• Dubuisson JB, Chapron C, Fauconnier A, Kreiker G. Laparoscopic myomectomy and myolysis. Curr Opin Obstet Gynecol. 1997 Aug;9(4):233-8.

  PMID: 9263713 BACKGROUND

• D'Alterio MN, Scicchitano F, Fanni D, Faa G, Laganà AS, Noventa M, et al. Ex vivo myolysis with dual wavelengths diode laser system: macroscopic and histopathological examination. CEOG. 2021;48(4):875-82

  BACKGROUND

• Nieuwenhuis LL, Hehenkamp WJK, Brolmann HAM, Huirne JAF. 3D power Doppler in uterine fibroids; influence of gain, cardiac cycle and off-line measurement techniques. J Obstet Gynaecol. 2018 Jan;38(1):103-109. doi: 10.1080/01443615.2017.1330323. Epub 2017 Aug 7.

  PMID: 28780884 BACKGROUND

• Vitale SG, Lagana AS, Torok P, Lasmar RB, Carugno J, Palumbo M, Tesarik J. Virtual sonographic hysteroscopy in assisted reproduction: A retrospective cost-effectiveness analysis. Int J Gynaecol Obstet. 2022 Jan;156(1):112-118. doi: 10.1002/ijgo.13651. Epub 2021 Mar 16.

  PMID: 33615469 BACKGROUND

• Fleischer AC. Sonographic depiction of tumor vascularity and flow: from in vivo models to clinical applications. J Ultrasound Med. 2000 Jan;19(1):55-61. doi: 10.7863/jum.2000.19.1.55.

  PMID: 10625191 BACKGROUND

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.

  PMID: 25046131 BACKGROUND

• Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.

  PMID: 21345435 BACKGROUND

• Carugno J, Grimbizis G, Franchini M, Alonso L, Bradley L, Campo R, Catena U, Carlo A, Attilio DSS, Martin F, Haimovich S, Isaacson K, Moawad N, Saridogan E, Clark TJ. International Consensus Statement for Recommended Terminology Describing Hysteroscopic Procedures. J Minim Invasive Gynecol. 2022 Mar;29(3):385-391. doi: 10.1016/j.jmig.2021.10.004. Epub 2021 Oct 12.

  PMID: 34648932 BACKGROUND

• Bettocchi S, Selvaggi L. A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc. 1997 Feb;4(2):255-8. doi: 10.1016/s1074-3804(97)80019-9.

  PMID: 9050737 BACKGROUND

• Tinelli R, Litta P, Angioni S, Bettocchi S, Fusco A, Leo L, Landi S, Cicinelli E. A multicenter study comparing surgical outcomes and ultrasonographic evaluation of scarring after laparoscopic myomectomy with conventional versus barbed sutures. Int J Gynaecol Obstet. 2016 Jul;134(1):18-21. doi: 10.1016/j.ijgo.2015.10.029. Epub 2016 Mar 31.

  PMID: 27209335 BACKGROUND

• Vitale SG, Riemma G, Haimovich S, Carugno J, Alonso Pacheco L, Perez-Medina T, Parry JP, Torok P, Tesarik J, Della Corte L, Cobellis L, Di Spiezio Sardo A, De Franciscis P. Risk of endometrial cancer in asymptomatic postmenopausal women in relation to ultrasonographic endometrial thickness: systematic review and diagnostic test accuracy meta-analysis. Am J Obstet Gynecol. 2023 Jan;228(1):22-35.e2. doi: 10.1016/j.ajog.2022.07.043. Epub 2022 Aug 4.

  PMID: 35932873 BACKGROUND

• Georgiou D, Tranoulis A, Jackson TL. Hysteroscopic tissue removal system (MyoSure) for the resection of polyps, sub-mucosal leiomyomas and retained products of conception in an out-patient setting: A single UK institution experience. Eur J Obstet Gynecol Reprod Biol. 2018 Dec;231:147-151. doi: 10.1016/j.ejogrb.2018.10.030. Epub 2018 Oct 12.

  PMID: 30388609 BACKGROUND

• Munro MG. Uterine polyps, adenomyosis, leiomyomas, and endometrial receptivity. Fertil Steril. 2019 Apr;111(4):629-640. doi: 10.1016/j.fertnstert.2019.02.008.

  PMID: 30929720 BACKGROUND

• Vilos GA, Vilos AG, Abu-Rafea B, Leyland N, Allaire C, Laberge PY, Murji A, Singh SS, Thiel J. Interventional Uterine-Sparing Therapies for Leiomyomas: A Commentary on Myolysis. J Obstet Gynaecol Can. 2020 Feb;42(2):169-172. doi: 10.1016/j.jogc.2019.08.025. Epub 2019 Nov 23.

  PMID: 31767379 BACKGROUND

Study Officials

• Sergio Haimovich, MD, PhD

  Laniado University Hospital - Ariel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Gynecology Department at the Laniado Hospital

Model Details: patients with symptomatic submucosal fibroides were elected for hysteroscopy laser ablation of the fibroid

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: November 3, 2022
• Study Start: January 1, 2018
• Primary Completion: January 30, 2019
• Study Completion: December 30, 2019
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

IL (1); ES (1); IT (2)