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

February 23, 2021 updated by: John Kachura, Mount Sinai Hospital, Canada
Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of life with femoral versus radial arterial access

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1Z5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5G2N2
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Femoral arterial access
Femoral arterial puncture for the uterine fibroid embolization procedure
Procedure: Arterial access
Location of arterial puncture
Experimental: Radial arterial access
Radial arterial puncture for the uterine fibroid embolization procedure
Procedure: Arterial access
Location of arterial puncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: From date of procedure to one month after procedure
Based on visual analog scale (min 0, max 10; higher score indicates better outcome)
From date of procedure to one month after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure related complication rate
Time Frame: Up to one month after procedure
Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline
Up to one month after procedure
Procedure time
Time Frame: Duration of intra-procedural time
Procedure time
Duration of intra-procedural time
Fluoroscopy Time
Time Frame: Duration of intra-procedural fluoroscopy
Fluoroscopy time used during the procedure
Duration of intra-procedural fluoroscopy
Procedure equipment cost
Time Frame: Procedure
Cost of disposable equipment used for the procedure
Procedure
Health related quality of life
Time Frame: 1 month post procedure
Health related quality of life short form-8 questionnaire (raw score converted to standardised score min 0, max 100; higher score indicates better outcome)
1 month post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: John Kachura, Mount Sinai Hospital, University Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0227-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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