Uterine FibroidSPARQLENCT03021720
Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial
A study testing Arterial access in people with Uterine Fibroid, run by Mount Sinai Hospital, Canada at 2 sites in Canada.
Trial summary
Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of life with femoral versus radial arterial access Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroid
- What is being tested?
- Arterial access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2016to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting standard eligibility criteria for uterine fibroid embolization
- Satisfactory ulnopalmar arch patency
Who cannot join
- Unable to provide informed consent
- Unable or unwilling to complete the study questionnaires
- Failed Barbeau test
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mount Sinai Hospital
Toronto, Ontario, M5G1Z5
University Health Network
Toronto, Ontario, M5G2N2
About this study
Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of life with femoral versus radial arterial access
Read the detailed description
1:1 randomized trial comparing patient satisfaction and quality of life with femoral versus radial arterial access for uterine fibroid embolization
- Conditions
- Uterine Fibroid
- Being tested
- Arterial access
- Keywords
- Uterine fibroid embolization, Uterine artery embolization, Arterial access, Radial access, Interventional radiology, Quality of life, Patient Satisfaction, Patient centered care, Uterine fibroid
- Medical subject headings
- Leiomyoma, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial accessProcedure or surgery
Location of arterial puncture
| Study group | Role | What they receive |
|---|---|---|
| Femoral arterial access | Active comparator | Femoral arterial puncture for the uterine fibroid embolization procedure Receives: Procedure: Arterial access |
| Radial arterial access | Experimental | Radial arterial puncture for the uterine fibroid embolization procedure Receives: Procedure: Arterial access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Based on visual analog scale (min 0, max 10; higher score indicates better outcome)
Measured: From date of procedure to one month after procedure
Secondary outcomes (5)
Procedure related complication rate
Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline
Measured: Up to one month after procedure
Procedure time
Procedure time
Measured: Duration of intra-procedural time
Fluoroscopy Time
Fluoroscopy time used during the procedure
Measured: Duration of intra-procedural fluoroscopy
Procedure equipment cost
Cost of disposable equipment used for the procedure
Measured: Procedure
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)
Measured: 1 month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Kachura, Mount Sinai Hospital, Canada
- Investigators
- John Kachura, Principal investigator, Mount Sinai Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021720
- Sponsor's protocol ID
- 16-0227-A
- Acronym
- SPARQLE
- Status last verified
- Feb 2021
- First submitted
- 9 Jan 2017
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial
- ClinicalTrials.gov ID
- NCT03021720
- Acronym / sponsor ID
- SPARQLE / 16-0227-A
- Conditions
- Uterine Fibroid
- Keywords
- Uterine fibroid embolization, Uterine artery embolization, Arterial access, Radial access, Interventional radiology, Quality of life, Patient Satisfaction, Patient centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral arterial access | Active comparator | Procedure: Arterial accessFemoral arterial puncture for the uterine fibroid embolization procedure |
| Radial arterial access | Experimental | Procedure: Arterial accessRadial arterial puncture for the uterine fibroid embolization procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meeting standard eligibility criteria for uterine fibroid embolization
- Satisfactory ulnopalmar arch patency
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Unable or unwilling to complete the study questionnaires
- Failed Barbeau test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial accessLocation of arterial puncture | Procedure or surgery | Femoral arterial access, Radial arterial access |
Primary outcome
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)
5 secondary outcomes
Procedure related complication rate
Time frame: Up to one month after procedure
Procedure time
Time frame: Duration of intra-procedural time
Fluoroscopy Time
Time frame: Duration of intra-procedural fluoroscopy
Procedure equipment cost
Time frame: Procedure
Health related quality of life
Time frame: 1 month post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kachura principal investigator
Mount Sinai Hospital, University Health Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial access in people with Uterine Fibroid, run by Mount Sinai Hospital, Canada at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: From date of procedure to one month after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.