Skip to main content


Ari Isaacson, MD

Jessie Stewart, M.D.
Jessie Stewart, MD

UNC Vascular-Interventional Radiology (VIR) faculty periodically facilitate industry-funded clinical trials that produce newly indicated, minimally invasive agents benefitting interventional radiology (IR) patients. In 2019, Terumo Medical Corporation funded two clinical studies conducted by VIR division faculty that tested the technical and clinical success of HydroPearl® microspheres in two types of IR procedures.

In April 2019, Associate Professor and Director of Clinical Research Dr. Ari Isaacson launched a Terumo-funded, one-year study entitled, “Safety and Efficacy of Prostatic Artery Embolization Using HydroPearl® Embolic Particles.”  Funded at over $42,000, Isaacson’s investigation will evaluate the effectiveness of using HydroPearl® microspheres in prostatic artery embolization (PAE). This well-established IR procedure has successfully treated lower urinary symptoms (LUTS) caused by Benign Prostatic Hyperplasia (BPH).

Dr. Isaacson’s study collects and analyzes safety and efficacy data of 25 UNC patients who previously underwent PAE using HydroPearl® microspheres during a one-year period.  Follow-up data from the electronic medical record and questionnaires will allow Isaacson’s team to determine technical and clinical success rates, as well as incidence of complications.

Dr. Isaacson’s study defines bilateral PAE and reduction of LUTS as technical and clinical success, respectively. For the latter, the study’s primary endpoint is a reduction in LUTS during the follow-up period using a standardized questionnaire.

Isaacson stated: “The retrospective study that we are doing evaluating HydroPearl® for PAE should be instrumental in the FDA’s determination of whether HydroPearl® should receive labeling specifically for PAE.”

In September 2019, Assistant Professor Dr. Jessie Stewart began a Terumo-funded, retrospective study entitled, “Uterine Artery Embolization Using HydroPearl® Embolic Particles.” Funded at over $29K, Dr. Stewart’s investigation assesses clinical outcomes of women with symptomatic uterine fibroids who are treated with uterine artery embolization (UAE) using Terumo’s HydroPearl® microspheres. These patients suffer from bleeding and/or bulk symptoms related to their uterine fibroids. While the HydroPearl® microspheres are FDA approved for the treatment of uterine fibroids, there is no specific data about the safety and efficacy of this embolic agent for this indication. Patients who had at least 3-month clinical follow-up were included in the study. The retrospective study will assess the safety and efficacy of this new embolic agent by reviewing documentation of complications and symptom response in the medical record. This data will be valuable to physicians considering whether to use this new embolic agent in the treatment of their patients.

Stewart noted: “Although the HydroPearl® embolic particle is already approved for uterine artery embolization for the treatment of uterine fibroids, this was based on its similarity to other FDA-approved embolic agents. It is important to investigate the real-life clinical outcomes of women undergoing UAE who are being treated with this new particle.”