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Completed

NCT Number: NCT03021720

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

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

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Key information

Conditions

Uterine Fibroid Behavior Health Behavior Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial access

Procedure

Location of arterial puncture

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Procedure time

    Time frame: Duration of intra-procedural time

    Procedure time

  3. Fluoroscopy Time

    Time frame: Duration of intra-procedural fluoroscopy

    Fluoroscopy time used during the procedure

  4. Procedure equipment cost

    Time frame: Procedure

    Cost of disposable equipment used for the procedure

  5. 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)

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Acronym: SPARQLE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 16, 2017
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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