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OpenTrials
Completed

NCT Number: NCT05604001

In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

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

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Key information

Conditions

Laser Hysteroscopic Ablation of Submucous Myoma

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laniado University Hospital, Netanya, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hysteroscopic ablation of submucous uterine fibroid using diode laser

Device

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

Primary outcomes

  1. Bleeding

    Time frame: before the procedure and at 3 months follow up visit

    improvement of the heavy menstrual bleeding

Secondary outcomes

  1. fibroid volume reduction

    Time frame: before the procedure and at 3 months follow up visit

    measure by US the reduction of the myoma size

  2. changes on the myoma vascularity

    Time frame: before the procedure and at 3 months follow up visit

    measure by 3D US Doppler Color

Sponsors and collaborators

Lead sponsor

Ariel University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 3, 2022
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.