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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03021720
Other study ID # 16-0227-A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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