NCT03021720

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

3.3 years

First QC Date

January 9, 2017

Last Update Submit

February 23, 2021

Conditions

Uterine Fibroid

Keywords

Uterine fibroid embolizationUterine artery embolizationArterial accessRadial accessInterventional radiologyQuality of lifePatient SatisfactionPatient centered careUterine fibroid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Procedure related complication rate

    Up to one month after procedure

  • Procedure time

    Duration of intra-procedural time

  • Fluoroscopy Time

    Duration of intra-procedural fluoroscopy

  • Procedure equipment cost

    Procedure

  • Health related quality of life

    1 month post procedure

Study Arms (2)

Femoral arterial access

ACTIVE COMPARATOR

Femoral arterial puncture for the uterine fibroid embolization procedure

Procedure: Arterial access

Radial arterial access

EXPERIMENTAL

Radial arterial puncture for the uterine fibroid embolization procedure

Procedure: Arterial access

Interventions

Arterial accessPROCEDURE

Location of arterial puncture

Femoral arterial accessRadial arterial access

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meeting standard eligibility criteria for uterine fibroid embolization
  • Satisfactory ulnopalmar arch patency

You may not qualify if:

  • Unable to provide informed consent
  • Unable or unwilling to complete the study questionnaires
  • Failed Barbeau test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G1Z5, Canada

Location

University Health Network

Toronto, Ontario, M5G2N2, Canada

Location

MeSH Terms

Conditions

LeiomyomaPatient Satisfaction

Interventions

Vascular Access Devices

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Study Officials

  • John Kachura

    Mount Sinai Hospital, University Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional Radiologist; Associate Professor of Medical Imaging

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 16, 2017

Study Start

November 1, 2016

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)