Status:
UNKNOWN
Characterisation of Uterine Fibroid Tissue Stiffness
Lead Sponsor:
Dr. Linda McLean
Collaborating Sponsors:
Ottawa Hospital Research Institute
The Ottawa Hospital
Conditions:
Leiomyoma
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
Uterine fibroids (leiomyomas, myomas, fibroids) are benign tumors of the uterus that can cause heavy menstrual bleeding, pain, and/or infertility. Fibroids can be managed with medication, surgery, or ...
Detailed Description
Aims and Objectives The goal of this project is to understand if and how uterine fibroid tissue stiffness, measured by SWE, can be used to predict and monitor response to medical therapy in patients w...
Eligibility Criteria
Inclusion
- Inclusion Criteria (All Participants)
- Age 18 or older
- Premenopausal
- No co-morbidities known to impact tissue properties
- Inclusion (FIB-Sx and FIB-Mx groups)
- Diagnosis of fibroids by imaging (FIB-Mx and FIB-Sx groups)
- Scheduled to undergo hysterectomy (FIB-Sx) or medical therapy (FIB-Mx) to treat symptomatic uterine fibroids
- \<6 fibroids identified by medical imaging
- Inclusion (CON group)
- no known history of gynecological pathologies
- regular menstrual cycles
- Exclusion Criteria (All Participants)
- confirmed or suspected uterine cancer
- pregnancy
- \<6months post-partum
- history of caesarean delivery
- previous uterine surgery
Exclusion
Key Trial Info
Start Date :
August 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03369600
Start Date
August 17 2018
End Date
July 31 2025
Last Update
May 10 2023
Active Locations (1)
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1
University of Ottawa, Motor Function Measurement Laboratory
Ottawa, Ontario, Canada, K1N 6N5