Clinical trial NCT05604001: In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids
Official title: In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids: Impact on Size and Vascularization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser Hysteroscopic Ablation of Submucous Myoma
Lead sponsor: Ariel University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients with symptomatic submucosal fibroides were elected for hysteroscopy laser ablation of the fibroid
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bleeding
timeFrame: before the procedure and at 3 months follow up visit
Secondary outcomes:
measure: fibroid volume reduction
timeFrame: before the procedure and at 3 months follow up visit
measure: changes on the myoma vascularity
timeFrame: before the procedure and at 3 months follow up visit
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Laniado University Hospital
city: Cagliari
country: Italy
facility: University of Cagliari
city: Napoli
country: Italy
facility: universita della campagna luigi Vanvitelli
city: Barcelona
country: Spain
facility: Parc de Salut Mar
Study officials:
affiliation: Laniado University Hospital - Ariel University
name: Sergio Haimovich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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