Back to resultsIn-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids
Primary Purpose
Laser Hysteroscopic Ablation of Submucous Myoma
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
hysteroscopic ablation of submucous uterine fibroid using diode laser
Sponsored by
About this trial
This is an interventional treatment trial for Laser Hysteroscopic Ablation of Submucous Myoma
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Laniado University Hospital
- University of Cagliari
- universita della campagna luigi Vanvitelli
- Parc de Salut Mar
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Symptomatic submucosal myoma
Arm Description
patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy with laser ablation of the myoma.
Outcomes
Primary Outcome Measures
Bleeding
improvement of the heavy menstrual bleeding
Secondary Outcome Measures
fibroid volume reduction
measure by US the reduction of the myoma size
changes on the myoma vascularity
measure by 3D US Doppler Color
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05604001
Brief Title
In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids
Official Title
In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids: Impact on Size and Vascularization.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ariel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate feasibility and efficacy of in-office hysteroscopic ablation of submucous uterine fibroid using diode laser
Detailed Description
A pilot study was conducted between January 2018 and January 2019 in a tertiary care university hospital. Patients with at least one symptomatic, class 0-2 of FIGO classification, uterine fibroid of ≤ 7cm in size were eligible for inclusion. Evaluation of the changes in fibroid size and vascularity was performed using 3D Doppler ultrasonography. Vaporization of the fibroid core was conducted using a 1470nm wavelength diode laser inserted through the hysteroscope's working channel. Primary outcome was the evaluation of the fibroid volume before and at 2 months after the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laser Hysteroscopic Ablation of Submucous Myoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients with symptomatic submucosal fibroides were elected for hysteroscopy laser ablation of the fibroid
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Symptomatic submucosal myoma
Arm Type
Experimental
Arm Description
patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy with laser ablation of the myoma.
Intervention Type
Device
Intervention Name(s)
hysteroscopic ablation of submucous uterine fibroid using diode laser
Intervention Description
patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy and laser ablation of the myoma
Primary Outcome Measure Information:
Title
Bleeding
Description
improvement of the heavy menstrual bleeding
Time Frame
before the procedure and at 3 months follow up visit
Secondary Outcome Measure Information:
Title
fibroid volume reduction
Description
measure by US the reduction of the myoma size
Time Frame
before the procedure and at 3 months follow up visit
Title
changes on the myoma vascularity
Description
measure by 3D US Doppler Color
Time Frame
before the procedure and at 3 months follow up visit
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
fiborid is a pathology that affects women´s uterus
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Haimovich, MD, PhD
Organizational Affiliation
Laniado University Hospital - Ariel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laniado University Hospital
City
Netanya
Country
Israel
Facility Name
University of Cagliari
City
Cagliari
Country
Italy
Facility Name
universita della campagna luigi Vanvitelli
City
Napoli
Country
Italy
Facility Name
Parc de Salut Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
26001875
Citation
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.
Results Reference
background
PubMed Identifier
28406809
Citation
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.
Results Reference
background
PubMed Identifier
23812380
Citation
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.
Results Reference
background
PubMed Identifier
30956472
Citation
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.
Results Reference
background
PubMed Identifier
33686708
Citation
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.
Results Reference
background
PubMed Identifier
27632410
Citation
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.
Results Reference
background
PubMed Identifier
26090457
Citation
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.
Results Reference
background
PubMed Identifier
8786884
Citation
Goldfarb HA. Laparoscopic coagulation of myoma (myolysis). Obstet Gynecol Clin North Am. 1995 Dec;22(4):807-19. No abstract available.
Results Reference
background
PubMed Identifier
11129695
Citation
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.
Results Reference
background
PubMed Identifier
9263713
Citation
Dubuisson JB, Chapron C, Fauconnier A, Kreiker G. Laparoscopic myomectomy and myolysis. Curr Opin Obstet Gynecol. 1997 Aug;9(4):233-8.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
28780884
Citation
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.
Results Reference
background
PubMed Identifier
33615469
Citation
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.
Results Reference
background
PubMed Identifier
10625191
Citation
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.
Results Reference
background
PubMed Identifier
25046131
Citation
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.
Results Reference
background
PubMed Identifier
21345435
Citation
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.
Results Reference
background
PubMed Identifier
34648932
Citation
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.
Results Reference
background
PubMed Identifier
9050737
Citation
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.
Results Reference
background
PubMed Identifier
27209335
Citation
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.
Results Reference
background
PubMed Identifier
35932873
Citation
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.
Results Reference
background
PubMed Identifier
30388609
Citation
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.
Results Reference
background
PubMed Identifier
30929720
Citation
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.
Results Reference
background
PubMed Identifier
31767379
Citation
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.
Results Reference
background
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In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids
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