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

Primary Purpose

Uterine Fibroid

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Arterial access
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Uterine Fibroid focused on measuring Uterine fibroid embolization, Uterine artery embolization, Arterial access, Radial access, Interventional radiology, Quality of life, Patient Satisfaction, Patient centered care, Uterine fibroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Hospital
  • University Health Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Femoral arterial access

Radial arterial access

Arm Description

Femoral arterial puncture for the uterine fibroid embolization procedure

Radial arterial puncture for the uterine fibroid embolization procedure

Outcomes

Primary Outcome Measures

Patient satisfaction
Based on visual analog scale (min 0, max 10; higher score indicates better outcome)

Secondary Outcome Measures

Procedure related complication rate
Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline
Procedure time
Procedure time
Fluoroscopy Time
Fluoroscopy time used during the procedure
Procedure equipment cost
Cost of disposable equipment used for the procedure
Health related quality of life
Health related quality of life short form-8 questionnaire (raw score converted to standardised score min 0, max 100; higher score indicates better outcome)

Full Information

First Posted
January 9, 2017
Last Updated
February 23, 2021
Sponsor
Mount Sinai Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03021720
Brief Title
Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial
Acronym
SPARQLE
Official Title
Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroid
Keywords
Uterine fibroid embolization, Uterine artery embolization, Arterial access, Radial access, Interventional radiology, Quality of life, Patient Satisfaction, Patient centered care, Uterine fibroid

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral arterial access
Arm Type
Active Comparator
Arm Description
Femoral arterial puncture for the uterine fibroid embolization procedure
Arm Title
Radial arterial access
Arm Type
Experimental
Arm Description
Radial arterial puncture for the uterine fibroid embolization procedure
Intervention Type
Procedure
Intervention Name(s)
Arterial access
Intervention Description
Location of arterial puncture
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
Based on visual analog scale (min 0, max 10; higher score indicates better outcome)
Time Frame
From date of procedure to one month after procedure
Secondary Outcome Measure Information:
Title
Procedure related complication rate
Description
Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline
Time Frame
Up to one month after procedure
Title
Procedure time
Description
Procedure time
Time Frame
Duration of intra-procedural time
Title
Fluoroscopy Time
Description
Fluoroscopy time used during the procedure
Time Frame
Duration of intra-procedural fluoroscopy
Title
Procedure equipment cost
Description
Cost of disposable equipment used for the procedure
Time Frame
Procedure
Title
Health related quality of life
Description
Health related quality of life short form-8 questionnaire (raw score converted to standardised score min 0, max 100; higher score indicates better outcome)
Time Frame
1 month post procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kachura
Organizational Affiliation
Mount Sinai Hospital, University Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1Z5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2N2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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