In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

Sponsor

Ariel University (Other)

Overall Status

Completed

CT.gov ID

NCT05604001

Collaborator

(none)

Enrollment

Location

Arm

23.9

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Laser Hysteroscopic Ablation of Submucous Myoma	Device: hysteroscopic ablation of submucous uterine fibroid using diode laser	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

patients with symptomatic submucosal fibroides were elected for hysteroscopy laser ablation of the fibroidpatients with symptomatic submucosal fibroides were elected for hysteroscopy laser ablation of the fibroid

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jan 30, 2019

Actual Study Completion Date :

Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Symptomatic submucosal myoma 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 patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy and laser ablation of the myoma

Arm

Intervention/Treatment

Experimental: Symptomatic submucosal myoma

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parc de Salut Mar	Barcelona		Spain	08003

Sponsors and Collaborators

Ariel University

Investigators

Principal Investigator: Sergio Haimovich, MD, PhD, Laniado University Hospital - Ariel University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Sergio Haimovich, Director of the Gynecology Department at the Laniado Hospital, Ariel University

ClinicalTrials.gov Identifier:

NCT05604001

Other Study ID Numbers:

LaMyA

First Posted:

Nov 3, 2022

Last Update Posted:

Nov 7, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Nov 7, 2022