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

NCT ID: NCT03164629

Last Updated: 2019-06-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2018-10-19

Brief Summary

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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.

Detailed Description

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Conditions

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Enlarged Prostate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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3D Angiogram + Emboguide

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.

Group Type EXPERIMENTAL

cone-beam CT 3D Emboguide

Intervention Type DEVICE

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

Embolization will be guided by a standard of care CT.

Group Type ACTIVE_COMPARATOR

cone-beam CT 3D Emboguide

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with biopsy proven prostate cancer
* Patient weight of \>300 lbs
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Siemens Corporation, Corporate Technology

INDUSTRY

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Shivank Bhatia

Assistant Professor of Clinical Radiology & Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shivank Bhatia

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Professional Arts Center

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20160589

Identifier Type: -

Identifier Source: org_study_id

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