In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

Not Applicable

Completed

• Conditions: Laser Hysteroscopic Ablation of Submucous Myoma

• 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

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)

Laniado University Hospital; 🇮🇱 Netanya, Israel

University of Cagliari; 🇮🇹 Cagliari, Italy

universita della campagna luigi Vanvitelli; 🇮🇹 Napoli, Italy

Parc de Salut Mar; 🇪🇸 Barcelona, Spain