Status:
UNKNOWN
OPPIuM Technique and Myolysis With Diode Laser Dwls
Lead Sponsor:
University of Cagliari
Collaborating Sponsors:
University of Foggia
Azienda Ospedaliera Ordine Mauriziano di Torino
Conditions:
Uterine Fibroid
Myoma;Uterus
Eligibility:
FEMALE
18-48 years
Phase:
NA
Brief Summary
PURPOSE OF THE STUDY The study aims to examine the feasibility and effectiveness of the OPPIuM technique combined with myolysis using the DWLS diode laser. In addition, to evaluate the reduction of my...
Detailed Description
BACKGROUND Leiomyomas or uterine fibroids are benign lesions that can cause infertility, uterine bleeding (hypermenorrhea, metrorrhagia, and menometrorrhagia), resulting in anemia, disorders in urinar...
Eligibility Criteria
Inclusion
- Women between 18 and 48 years old
- Diagnosis of symptomatic uterine fibromatosis (abnormal uterine bleeding, pelvic pain and/or infertility) with single fibroma ≤ 3 cm G1 or G2.
Exclusion
- Patients who are unable to provide written informed consent or to follow the procedures set out in the protocol.
- Patients with malignant neoplasms or serious systemic diseases
- Patients with multiple fibroids or single \> 3 cm
- Asymptomatic patients
- Patients with other uterine or related diseases
- Patients seeking for a pregnancy.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04748978
Start Date
September 1 2020
End Date
January 1 2022
Last Update
February 15 2021
Active Locations (1)
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1
University of Cagliari,Obstetrics and Gynecological Department,
Monserrato, Cagliari, Italy, 09042