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

Uterine Fibroid Clinical Trial

— SPARQLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021720
• Other study ID #: 16-0227-A
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: February 2020

Study information

• Verified date: February 2021
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid

Intervention

Procedure:
• Arterial access
Location of arterial puncture

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	Based on visual analog scale (min 0, max 10; higher score indicates better outcome)	From date of procedure to one month after procedure
Secondary	Procedure related complication rate	Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline	Up to one month after procedure
Secondary	Procedure time	Procedure time	Duration of intra-procedural time
Secondary	Fluoroscopy Time	Fluoroscopy time used during the procedure	Duration of intra-procedural fluoroscopy
Secondary	Procedure equipment cost	Cost of disposable equipment used for the procedure	Procedure
Secondary	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)	1 month post procedure