In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

Not Applicable

Completed

• Conditions: Laser Hysteroscopic Ablation of Submucous Myoma
• Interventions: Device: hysteroscopic ablation of submucous uterine fibroid using diode laser

• Registration Number: NCT05604001
• Lead Sponsor: Ariel University

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-30
• Study Completion: 2019-12-30
• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Symptomatic submucosal myoma	hysteroscopic ablation of submucous uterine fibroid using diode laser	patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy with laser ablation of the myoma.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Parc de Salut Mar; 🇪🇸 Barcelona, Spain

Laniado University Hospital; 🇮🇱 Netanya, Israel

universita della campagna luigi Vanvitelli; 🇮🇹 Napoli, Italy

University of Cagliari; 🇮🇹 Cagliari, Italy