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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06153667




Registration number
NCT06153667
Ethics application status
Date submitted
22/11/2023
Date registered
1/12/2023
Date last updated
22/11/2024

Titles & IDs
Public title
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
Scientific title
Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
Secondary ID [1] 0 0
UFE-P4-23-01
Universal Trial Number (UTN)
Trial acronym
BETTER-UAE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Fibroid 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Bearing nsPVA

Treatment: Devices: Bearing nsPVA
Bearing nsPVA Embolization Particles are irregularly-shaped, biocompatible, hydrophilic, nonresorbable particles produced from polyvinyl alcohol. These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon selective placement through a variety of catheters. Bearing nsPVA Embolization Particles are used for the embolization of symptomatic (leiomyoma uteri) uterine fibroids.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety
Assessment method [1] 0 0
The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Primary Effectiveness
Assessment method [2] 0 0
The primary effectiveness endpoint will be clinical success defined as = 50% improvement in the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Symptom Severity subscale at 6 months as compared to baseline.
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
* Adult women = 18 years old at the time of enrollment.
* Subject has symptomatic uterine fibroid(s), suitable to embolization.
* Subject provides written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject is pregnant.
* Subject has suspected pelvic inflammatory disease or any other pelvic infection.
* Subject has any malignancy of the pelvic region, (e.g., endometrial neoplasia).

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Health - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merit Medical Systems, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Irene Coughlin
Address 0 0
Country 0 0
Phone 0 0
6175435665
Email 0 0
irene.coughlin@merit.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06153667