Recruiting

Bearing nsPVA

Sponsor:

Merit Medical Systems, Inc.

Code:

NCT06153667

Conditions

Uterine Fibroid

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bearing nsPVA

Study Details

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.

Conditions

Uterine Fibroid

Study ID

NCT06153667

Start date

Aug 22, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Primary Safety [ Time Frame: 30 days ]
  • Primary Effectiveness [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Molly Ryan

314-620-7095molly.ryan@merit.com

Vicky Brunk

vicky.brunk@merit.com

Locations

Astra Vascular/Astra Vein Treatment Center

Recruiting

Brooklyn, New York, United States, 11234

Contacts

Eridona Reci

347-672-2819eridona.reci@yahoo.com

Principal Investigator:

George Bolotin, MD

More Information

Sponsor

Merit Medical Systems, Inc.

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Merit Medical Systems, Inc. on 2026-04-01.