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Bearing nsPVA Embolization for Uterine Artery Embolization

Sponsor
Merit Medical Systems, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06153667
Collaborator
(none)
100
Enrollment
18
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.

Condition or Disease Intervention/Treatment Phase
  • Device: Bearing nsPVA

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
Anticipated Study Start Date :
Apr 1, 2024
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Primary Safety [30 days]

    The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.

  2. Primary Effectiveness [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Merit Medical Systems, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merit Medical Systems, Inc.
ClinicalTrials.gov Identifier:
NCT06153667
Other Study ID Numbers:
  • UFE-P4-23-01
First Posted:
Dec 1, 2023
Last Update Posted:
Dec 1, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leiomyoma
Myofibroma

Study Results

No Results Posted as of Dec 1, 2023