Satisfaction of Patients With Trans-Arterial Radial Acces... | NCT03021720

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

NCT03021720

Sponsor

Mount Sinai Hospital, Canada

Status

Completed

Last Update Posted

Feb 25, 2021Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Uterine Fibroid

Interventions

Arterial access

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Feb 2020Actual

Completion Date

Feb 2020Actual

First Submitted Date

Jan 9, 2017

First Submission Date that Met QC Criteria

Jan 12, 2017

First Posted Date

Jan 16, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2021

Last Update Posted Date

Feb 25, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Kachura, Interventional Radiologist; Associate Professor of Medical Imaging, Mount Sinai Hospital, CanadaPrincipal Investigator

Lead Sponsor

Mount Sinai Hospital, CanadaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Arterial access	Procedure	Location of arterial puncture	Femoral arterial access Radial arterial access

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Procedure related complication rate	Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline	Up to one month after procedure
Procedure time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Kachura	Mount Sinai Hospital, University Health Network	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Hospital		Toronto	Ontario	M5G1Z5	Canada
University Health Network

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007889	Leiomyoma
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062666	Vascular Access Devices

Ancestor Terms

ID	Term
D057785	Catheters
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided