Laser Hysteroscopic Ablation of Submucous MyomaNCT05604001

In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

A study testing hysteroscopic ablation of submucous uterine fibroid using diode laser in people with Laser Hysteroscopic Ablation of Submucous Myoma, run by Ariel University at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate feasibility and efficacy of in-office hysteroscopic ablation of submucous uterine fibroid using diode laser Read more about this study

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Laser Hysteroscopic Ablation of Submucous Myoma
What is being tested?: hysteroscopic ablation of submucous uterine fibroid using diode laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 4 sitesin 3 countries
Study dates: 1 Jan 2018to 30 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

Italy2 sites

University of Cagliari
Cagliari
universita della campagna luigi Vanvitelli
Naples

Other trials in Italy

Israel1 site

Laniado University Hospital
Netanya

Other trials in Israel

Spain1 site

Parc de Salut Mar
Barcelona, 08003

Other trials in Spain

About this study

Official title: In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids: Impact on Size and Vascularization.

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

Read the 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.

Conditions: Laser Hysteroscopic Ablation of Submucous Myoma
Being tested: hysteroscopic ablation of submucous uterine fibroid using diode laser

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

hysteroscopic ablation of submucous uterine fibroid using diode laserDevice
patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy and laser ablation of the myoma

Study groups in NCT05604001
Study group	Role	What they receive
Symptomatic submucosal myoma	Experimental	patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy with laser ablation of the myoma. Receives: Device: hysteroscopic ablation of submucous uterine fibroid using diode laser

What is being measured

The primary outcome is the main question the study is designed to answer.

Bleeding
improvement of the heavy menstrual bleeding
Measured: before the procedure and at 3 months follow up visit

Secondary outcomes (2)

fibroid volume reduction
measure by US the reduction of the myoma size
Measured: before the procedure and at 3 months follow up visit
changes on the myoma vascularity
measure by 3D US Doppler Color
Measured: before the procedure and at 3 months follow up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201830 Dec 2019

First posted3 Nov 2022
Study start1 Jan 2018
Primary completion30 Jan 2019
Study completion30 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Laser Hysteroscopic Ablation of Submucous MyomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: patients with symptomatic submucosal fibroides were elected for hysteroscopy laser ablation of the fibroid
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05604001
Sponsor's protocol ID: LaMyA
Status last verified: Jul 2023
First submitted: 23 Oct 2022
Last updated: 24 Jul 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 26001875
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.
PubMed 28406809
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.
PubMed 23812380
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.
PubMed 30956472
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.
PubMed 33686708
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.
PubMed 27632410
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.
PubMed 26090457
Goldfarb HA. Laparoscopic coagulation of myoma (myolysis). Obstet Gynecol Clin North Am. 1995 Dec;22(4):807-19. No abstract available.
PubMed 8786884
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.
PubMed 11129695
Dubuisson JB, Chapron C, Fauconnier A, Kreiker G. Laparoscopic myomectomy and myolysis. Curr Opin Obstet Gynecol. 1997 Aug;9(4):233-8.
PubMed 9263713
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
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.
PubMed 28780884
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.
PubMed 33615469
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.
PubMed 10625191
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.
PubMed 25046131

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids: Impact on Size and Vascularization.
ClinicalTrials.gov ID: NCT05604001
Acronym / sponsor ID: LaMyA
Conditions: Laser Hysteroscopic Ablation of Submucous Myoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Ariel UniversityUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 30 Jan 2019 (actual)
Study completion: 30 Dec 2019 (actual)
First posted: 3 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: patients with symptomatic submucosal fibroides were elected for hysteroscopy laser ablation of the fibroid

Arm	Type	Receives
Symptomatic submucosal myoma	Experimental	Device: hysteroscopic ablation of submucous uterine fibroid using diode laserpatients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy with laser ablation of the myoma.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

intramural fibroids (FIGO class 3 or more),
>2 submucosal fibroids,
pelvic inflammatory disease,
known gynecologic malignancy,
severe cervical stenosis,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
hysteroscopic ablation of submucous uterine fibroid using diode laserpatients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy and laser ablation of the myoma	Device	Symptomatic submucosal myoma

Primary outcome

Bleeding
Time frame: before the procedure and at 3 months follow up visit
improvement of the heavy menstrual bleeding

2 secondary outcomes

fibroid volume reduction
Time frame: before the procedure and at 3 months follow up visit
changes on the myoma vascularity
Time frame: before the procedure and at 3 months follow up visit

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
Background: PubMed 26001875Carranza-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.
Background: PubMed 28406809Valentine LN, Bradley LD. Hysteroscopy for Abnormal Uterine Bleeding and Fibroids. Clin Obstet Gynecol. 2017 Jun;60(2):231-244. doi: 10.1097/GRF.0000000000000287.
Background: PubMed 23812380Capmas 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.
Background: PubMed 30956472Yendru 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.
Background: PubMed 33686708Vitale 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.
Background: PubMed 27632410Nappi 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.
Background: PubMed 26090457Haimovich 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.
Background: PubMed 8786884Goldfarb HA. Laparoscopic coagulation of myoma (myolysis). Obstet Gynecol Clin North Am. 1995 Dec;22(4):807-19. No abstract available.
Background: PubMed 11129695Donnez 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.
Background: PubMed 9263713Dubuisson JB, Chapron C, Fauconnier A, Kreiker G. Laparoscopic myomectomy and myolysis. Curr Opin Obstet Gynecol. 1997 Aug;9(4):233-8.
BackgroundD'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: PubMed 28780884Nieuwenhuis 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sergio Haimovich, MD, PhD principal investigator

Laniado University Hospital - Ariel University

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy, Israel, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding (time frame: before the procedure and at 3 months follow up visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05604001, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.