In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

July 21, 2023 updated by: Sergio Haimovich, Ariel University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Netanya, Israel
        • Laniado University Hospital
  • Italy
      • Cagliari, Italy
        • University of Cagliari
      • Napoli, Italy
        • universita della campagna luigi Vanvitelli
  • Spain
      • Barcelona, Spain, 08003
        • Parc de Salut Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: before the procedure and at 3 months follow up visit
improvement of the heavy menstrual bleeding
before the procedure and at 3 months follow up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fibroid volume reduction
Time Frame: before the procedure and at 3 months follow up visit
measure by US the reduction of the myoma size
before the procedure and at 3 months follow up visit
changes on the myoma vascularity
Time Frame: before the procedure and at 3 months follow up visit
measure by 3D US Doppler Color
before the procedure and at 3 months follow up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ariel University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

October 23, 2022

First Submitted That Met QC Criteria

October 27, 2022

First Posted (Actual)

November 3, 2022

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LaMyA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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