Uterine FibroidRAVI RegistryNCT04272216

An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

An observational study of Uterine Fibroid and Arteriovenous Malformations, run by Terumo Medical Corporation at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Uterine Fibroid, Arteriovenous Malformations, Hypervascular Tumors
What is being tested?: Treatment with HydroPearl via radial access
Type of treatment: Medical device
How many people: 99 participants
Where: 6 sitesUnited States
Study dates: 6 Feb 2020to 11 Mar 2023
How long will I take part?: 12 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: This is a prospective, multi-center, registry study to assess the procedural success, technical success, and complication rate of radial access procedures using HydroPearl microspheres.

Who may be able to join

Subject is ≥ 18 years old
Subject is scheduled for a procedure for treatment with HydroPearl microspheres using radial access.
Subject is willing and able to complete follow-up requirements
Subject is willing and able to sign a written Informed Consent form prior to participating in the registry.

Who cannot join

Unable to have a procedure with radial access for any reason.
Participating in another clinical study which, in the opinion of the investigator, could impact the results of this registry.
Pregnant or planning to become pregnant during the study.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

UNC
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
University of California - Los Angeles
Los Angeles, California, 90095
Mount Sinai
New York, New York, 11766
SLU Department of Radiology
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: The RAVI Registry: A Prospective, Multi-Center, Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.

Conditions: Uterine Fibroid, Arteriovenous Malformations, Hypervascular Tumors, Benign Prostatic Hyperplasia
Being tested: Treatment with HydroPearl via radial access
Medical subject headings: Leiomyoma, Arteriovenous Malformations, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment with HydroPearl via radial accessDevice
This is an observational study collecting data on patients who are already being treated with HydroPearl on-label per standard of care.

Study groups in NCT04272216
Study group	Role	What they receive
Treatment with HydroPearl via radial access		all patients will be in the same group/cohort in this open-label, single-arm, observational registry. Receives: Device: Treatment with HydroPearl via radial access

What is being measured

The primary outcome is the main question the study is designed to answer.

Procedural Success
Defined as completing the planned procedure without femoral access bailout
Measured: Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))
Technical Success
Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization
Measured: Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed)
Freedom From Major Adverse Events and Radial Access Complications
Major Adverse Events are defined as the following:
Death MI Stroke
Measured: within 30 days post-procedure
Radial Access Related Complications Within 30 Days
Radial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following:
Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure
Measured: 30 days post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 202011 Mar 2023

First posted17 Feb 2020
Study start6 Feb 2020
Primary completion7 Mar 2022
Study completion11 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Uterine FibroidStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 99 participants (actual)
Target duration: 12 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04272216
Sponsor's protocol ID: TIS2019-02
Acronym: RAVI Registry
Status last verified: Oct 2021
First submitted: 13 Feb 2020
Last updated: 9 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingObservational study
The Effects of Uterine Fibroids on Pregnancy in Women
Female Infertility, Uterine Fibroid
RecruitingObservational study
Epidemiology and Risk Factors of Uterine Fibroids in China
Uterine Fibroid

All Uterine Fibroid trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The RAVI Registry: A Prospective, Multi-Center, Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres
ClinicalTrials.gov ID: NCT04272216
Acronym / sponsor ID: RAVI Registry / TIS2019-02
Conditions: Uterine Fibroid, Arteriovenous Malformations, Hypervascular Tumors, Benign Prostatic Hyperplasia
Study type: Observational
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Terumo Medical CorporationIndustry (pharma, biotech, devices)
Study start: 6 Feb 2020 (actual)
Primary completion: 7 Mar 2022 (actual)
Study completion: 11 Mar 2023 (actual)
First posted: 17 Feb 2020 (actual)
Results: Posted 9 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 12 Months
Number of arms: 1

Arm	Type	Receives
Treatment with HydroPearl via radial access	–	Device: Treatment with HydroPearl via radial accessall patients will be in the same group/cohort in this open-label, single-arm, observational registry.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This is a prospective, multi-center, registry study to assess the procedural success, technical success, and complication rate of radial access procedures using HydroPearl microspheres.

Key inclusion criteria (4 listed)

Subject is ≥ 18 years old
Subject is scheduled for a procedure for treatment with HydroPearl microspheres using radial access.
Subject is willing and able to complete follow-up requirements
Subject is willing and able to sign a written Informed Consent form prior to participating in the registry.

Key exclusion criteria (3 listed)

Unable to have a procedure with radial access for any reason.
Participating in another clinical study which, in the opinion of the investigator, could impact the results of this registry.
Pregnant or planning to become pregnant during the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment with HydroPearl via radial accessThis is an observational study collecting data on patients who are already being treated with HydroPearl on-label per standard of care.	Device	Treatment with HydroPearl via radial access

Primary outcome

Procedural Success
Time frame: Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))
Defined as completing the planned procedure without femoral access bailout
Technical Success
Time frame: Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed)
Delivery of HydroPearls to the target vessel and slowing the blood flow with microsphere embolization
Freedom From Major Adverse Events and Radial Access Complications
Time frame: within 30 days post-procedure
Major Adverse Events are defined as the following: Death MI Stroke
Radial Access Related Complications Within 30 Days
Time frame: 30 days post procedure
Radial access related complications that occurred within 30 days of the index procedure include, but are not limited to, the following: Radial Artery Occlusion (RAO) Hand Ischemia Arteriovenous Fistula Pseudoaneurysm Any complication requiring surgical and/or endovascular intervention within 30 days of the index procedure

Results and safety

Results posted to the registry on 9 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Uterine Fibroid Embolization With HydroPearls Via Radial Access	70	45
Prostatic Artery Embolization With HydroPearls Via Radial Access	16	8
Liver Tumor Embolization With HydroPearls Via Radial Access	7	2
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access	6	5

Primary outcome: Procedural Success

Time frame: Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure)). Count of participants. Unit: Participants

Measure	Uterine Fibroid Embolization With HydroPearls Via Radial Access n = 70	Prostatic Artery Embolization With HydroPearls Via Radial Access n = 16	Liver Tumor Embolization With HydroPearls Via Radial Access n = 7	Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access n = 6
Value	70	16	7	6

Primary outcome: Technical Success

Time frame: Duration of procedure (from when the injection of HydroPearls is started until access site closure has been completed). Count of participants. Unit: Participants

Measure	Uterine Fibroid Embolization With HydroPearls Via Radial Access n = 70	Prostatic Artery Embolization With HydroPearls Via Radial Access n = 16	Liver Tumor Embolization With HydroPearls Via Radial Access n = 7	Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access n = 6
Successful delivery of HydroPearls to target vessels	69	16	7	6
Complete Embolization	69	14	7	6
Partial Embolization	1	2	0	0

Primary outcome: Freedom From Major Adverse Events and Radial Access Complications

Time frame: within 30 days post-procedure. Count of participants. Unit: Participants

Measure	Uterine Fibroid Embolization With HydroPearls Via Radial Access n = 70	Prostatic Artery Embolization With HydroPearls Via Radial Access n = 16	Liver Tumor Embolization With HydroPearls Via Radial Access n = 7	Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access n = 6
Freedom from Major Adverse Events and radial access complications within 30 days post procedure	69	16	6	6
Death within 30 days	1	0	1	0
MI within 30 days	0	0	0	0
Stroke within 30 days	0	0	0	0

Primary outcome: Radial Access Related Complications Within 30 Days

Time frame: 30 days post procedure. Count of participants. Unit: Participants

Measure	Uterine Fibroid Embolization With HydroPearls Via Radial Access n = 70	Liver Tumor Embolization With HydroPearls Via Radial Access n = 7	Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access n = 6
Vessel occlusion	0	0	0
Hand Ischemia	0	0	0
Arteriovenous fistula	0	0	0
Pseudoaneurysm	0	0	0
Vessel dissection	0	0	0
Vessel spasm	4	1	1
Artery perforation	0	0	0
Distal embolization	0	0	0

Adverse events

Time frame: Within 30 days of index procedure. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Uterine Fibroid Embolization With HydroPearls Via Radial Access	6 of 70 (8.6%)	32 of 70 (45.7%)	1 of 70
Prostatic Artery Embolization With HydroPearls Via Radial Access	0 of 16 (0%)	9 of 16 (56.3%)	0 of 16
Liver Tumor Embolization With HydroPearls Via Radial Access	1 of 7 (14.3%)	4 of 7 (57.1%)	1 of 7
Other Hypervascular Tumor Embolization With HydroPearls Via Radial Access	2 of 6 (33.3%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcelo Guimaraes, MD principal investigator

Medical University of South Carolina

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Uterine Fibroid and Arteriovenous Malformations, run by Terumo Medical Corporation at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural Success (time frame: Duration of procedure (measured from the time the participant is sedated (start of study procedure) until all products are removed from the participant and closure is confirmed (end of the intended study procedure))). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04272216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.