NCT05604001

In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ariel University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Laser Hysteroscopic Ablation of Submucous Myoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-01-30
• Completion: 2019-12-30
• First posted: 2022-11-03
• Last updated: 2023-07-24

Locations

4 sites across 3 countries: Israel, Italy, Spain