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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03021720

Acronym

SPARQLE

Enrollment

Registered

2017-01-16

Start date

2016-11-30

Completion date

2020-02-29

Last updated

2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

PROCEDUREArterial access

Location of arterial puncture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Procedure related complication rate	Up to one month after procedure	Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline
Procedure time	Duration of intra-procedural time	Procedure time
Fluoroscopy Time	Duration of intra-procedural fluoroscopy	Fluoroscopy time used during the procedure
Procedure equipment cost	Procedure	Cost of disposable equipment used for the procedure
Health related quality of life	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)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026