Enlarged ProstateNCT03164629

3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization

A study testing cone-beam CT 3D Emboguide in people with Enlarged Prostate, run by University of Miami at 1 site 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

The purpose of this research study is to learn about how cone-beam Computerized Tomography scans (X-ray images taken from different angles) work together with an embolization guidance software (helps the doctor see the arteries that feed the prostate)to find and see arteries in the prostate. Read more about this study

Who is it for?: Ages 50 to 79 years, men only
Conditions the study is for: Enlarged Prostate
What is being tested?: cone-beam CT 3D Emboguide
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2017to 19 Oct 2018
Phase: Interventional
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 50 to 79 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is age 50 to 79, inclusive
Patients undergoing Prostate artery embolization for BPH or urinary retention -Patient has signed informed consent.

Who cannot join

Patients with biopsy proven prostate cancer
Patient weight of >300 lbs

Trial locations and contacts

1 site in 1 country.

United States1 site

Professional Arts Center
Miami, Florida, 33136

Other trials in United States

About this study

Conditions: Enlarged Prostate
Being tested: cone-beam CT 3D Emboguide
Keywords: BPH, Lower Urinary Track Infection, Urine Retention
Medical subject headings: Urinary Retention

What participants receive

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

cone-beam CT 3D EmboguideDevice
cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.

Study groups in NCT03164629
Study group	Role	What they receive
3D Angiogram + Emboguide	Experimental	Participants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels. Receives: Device: cone-beam CT 3D Emboguide
No 3D Angiogram + Emboguide	Active comparator	Embolization will be guided by a standard of care CT. Receives: Device: cone-beam CT 3D Emboguide

What is being measured

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

Time for Prostatic Artery Catheterization
For the cases using Emboguide this will be measured as the time from which the Emboguide is displayed on the live fluoroscopy to the time of prostatic artery catheterization. Emboguide display is in addition to the angiogram roadmap display.
For the control cases this will be measured as the time from which the angiogram is displayed on the live fluoroscopy to the time of prostatic artery catheterization.
Measured: hour 2

Timeline

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

17 Apr 201719 Oct 2018

First posted23 May 2017
Study start17 Apr 2017
Primary completion19 Oct 2018
Study completion19 Oct 2018

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 Enlarged ProstateStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03164629
Sponsor's protocol ID: 20160589
Status last verified: Jun 2019
First submitted: 22 May 2017
Last updated: 11 Jun 2019
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

Recruiting
To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.
Benign Prostatic Hyperplasia (BPH)
Recruiting
Moses 2.0 vs Magneto for HoLEP - a Randomized Controlled Trial
Enlarged Prostate (BPH), Benign Prostatic Hyperplasia
Not yet recruitingObservational study
A Study to Track the Safety of Vesomni in Men in South Korea Treated in Routine Clinical Practice for the Urinary Symptoms of Benign Prostatic Hyperplasia (Enlarged Prostate)
Benign Prostatic Hyperplasia
Enrolling by invitation
Emsella for Reducing tSUI After HOLEP
Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms
Recruiting
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction

All Enlarged Prostate trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization
ClinicalTrials.gov ID: NCT03164629
Acronym / sponsor ID: 20160589
Conditions: Enlarged Prostate
Keywords: BPH, Lower Urinary Track Infection, Urine Retention
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: Siemens Corporation, Corporate Technology
Study start: 17 Apr 2017 (actual)
Primary completion: 19 Oct 2018 (actual)
Study completion: 19 Oct 2018 (actual)
First posted: 23 May 2017 (actual)
Results: Posted 21 May 2019

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
3D Angiogram + Emboguide	Experimental	Device: cone-beam CT 3D EmboguideParticipants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.
No 3D Angiogram + Emboguide	Active comparator	Device: cone-beam CT 3D EmboguideEmbolization will be guided by a standard of care CT.

Who may qualify

Ages: 50 to 79 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient is age 50 to 79, inclusive
Patients undergoing Prostate artery embolization for BPH or urinary retention -Patient has signed informed consent.

Key exclusion criteria (2 listed)

Patients with biopsy proven prostate cancer
Patient weight of >300 lbs

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
cone-beam CT 3D Emboguidecone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.	Device	3D Angiogram + Emboguide, No 3D Angiogram + Emboguide

Primary outcome

Time for Prostatic Artery Catheterization
Time frame: hour 2
For the cases using Emboguide this will be measured as the time from which the Emboguide is displayed on the live fluoroscopy to the time of prostatic artery catheterization. Emboguide display is in addition to the angiogram roadmap display. For the control cases this will be measured as the time from which the angiogram is displayed on the live fluoroscopy to the time of prostatic artery catheterization.

Results and safety

Results posted to the registry on 21 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3D Angiogram + Emboguide	25	25
No 3D Angiogram + Emboguide	25	25

Primary outcome: Time for Prostatic Artery Catheterization

Time frame: hour 2. Mean (Standard Deviation). Unit: seconds

Measure	3D Angiogram + Emboguide n = 25	No 3D Angiogram + Emboguide n = 25
Right Artery	273.40 (406.64)	181.71 (185.11)
Left Artery	206.38 (228.96)	155.96 (216.32)

Population analysed: at times unable to catheterize the participants arteries

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3D Angiogram + Emboguide	0 of 25 (0%)	0 of 25 (0%)	0 of 25
No 3D Angiogram + Emboguide	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Enlarged Prostate

Recruiting
To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.
Benign Prostatic Hyperplasia (BPH)
Recruiting
Moses 2.0 vs Magneto for HoLEP - a Randomized Controlled Trial
Enlarged Prostate (BPH), Benign Prostatic Hyperplasia
Not yet recruitingObservational study
A Study to Track the Safety of Vesomni in Men in South Korea Treated in Routine Clinical Practice for the Urinary Symptoms of Benign Prostatic Hyperplasia (Enlarged Prostate)
Benign Prostatic Hyperplasia
Enrolling by invitation
Emsella for Reducing tSUI After HOLEP
Benign Prostatic Hyperplasia, Enlarged Prostate With Lower Urinary Tract Symptoms
Recruiting
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction

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.

Shivank Bhatia principal investigator

University of Miami

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

Questions about this trial

What is this clinical trial studying?

A study testing cone-beam CT 3D Emboguide in people with Enlarged Prostate, run by University of Miami at 1 site 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 2 inclusion and 2 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 21 May 2019). 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?

Time for Prostatic Artery Catheterization (time frame: hour 2). 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 NCT03164629.

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 11 Jun 2019.