Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial

NCT ID: NCT03021720

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-02-29

Brief Summary

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Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of life with femoral versus radial arterial access

Detailed Description

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1:1 randomized trial comparing patient satisfaction and quality of life with femoral versus radial arterial access for uterine fibroid embolization

Conditions

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Uterine Fibroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Femoral arterial access

Femoral arterial puncture for the uterine fibroid embolization procedure

Group Type ACTIVE_COMPARATOR

Arterial access

Intervention Type PROCEDURE

Location of arterial puncture

Radial arterial access

Radial arterial puncture for the uterine fibroid embolization procedure

Group Type EXPERIMENTAL

Arterial access

Intervention Type PROCEDURE

Location of arterial puncture

Interventions

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Arterial access

Location of arterial puncture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Meeting standard eligibility criteria for uterine fibroid embolization
* Satisfactory ulnopalmar arch patency

Exclusion Criteria

* Unable to provide informed consent
* Unable or unwilling to complete the study questionnaires
* Failed Barbeau test
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mount Sinai Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

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John Kachura

Interventional Radiologist; Associate Professor of Medical Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Kachura

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, University Health Network

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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16-0227-A

Identifier Type: -

Identifier Source: org_study_id

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