WrinkleNCT04240080
Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment
A study testing Accuvein® Veinfinder in people with Wrinkle, run by Mayo Clinic.
Trial summary
Researchers are studying how vein mapping impacts patient outcomes and satisfaction after facial injection procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Accuvein® Veinfinder
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2020to Dec 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients pursuing aesthetic/therapeutic facial injection procedures (botox/filler)
Who cannot join
- Patients undergoing aesthetic facial procedures not requiring needle injection
About this study
Official title: The Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment
Researchers are studying how vein mapping impacts patient outcomes and satisfaction after facial injection procedures.
Read the detailed description
Facial Botox/filler injections carry risk of puncturing superficial veins, leading to bruising and pain. Our study will investigate the utility of non-invasive vein imaging (specifically near-infrared light reflection) on the incidence of pain/bruising/hematoma and patient satisfaction after facial injections.
The current standard of care for facial injection procedures does not involve any modality of facial venous mapping. Vein mapping is a non-invasive, simple task that takes very little time to conduct. One risk is patient time, however maximum extra time needed will be 5 minutes during the clinical visit. This potential extra time in mind, the benefits far outweigh the risks.
Two cohorts of patients will be prospectively compared following randomization, those who did have pre-procedure venous mapping prior to injection versus those who did not. Data will be analyzed with regard to bruising and swelling following injection, as well as other potential complications such as hematoma or infection, along with patient satisfaction survey information.
- Conditions
- Wrinkle
- Being tested
- Accuvein® Veinfinder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuvein® VeinfinderDevice
Near-infrared light reflection utilized by healthcare providers to see superficial veins under the skin.
| Study group | Role | What they receive |
|---|---|---|
| Control Goup | No intervention | Subjects will undergo clinically indicated facial injection procedures per standard of care without venous mapping |
| Intervention Group | Experimental | Subjects will undergo clinically indicated facial injection procedure with pre-procedural facial venous mapping by Accuvein® Veinfinder Receives: Device: Accuvein® Veinfinder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Measured using the self-reported FACE-Q satisfaction score, using a scale of 1=definitely disagree and 4=definitely agree
Measured: Approximately 7-10 days following the procedure
Secondary outcomes (1)
Rate of Bruising/Hematoma
Number of subjects to experience bruising/hematoma post facial injection procedure
Measured: Approximately 7-10 days following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start10 Jan 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Practice volume was low and resulted in a lack of participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William J. Casey, III, Mayo Clinic
- Investigators
- William Casey III, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240080
- Sponsor's protocol ID
- 19-011561
- Status last verified
- Apr 2024
- First submitted
- 22 Jan 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment
- ClinicalTrials.gov ID
- NCT04240080
- Acronym / sponsor ID
- 19-011561
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Practice volume was low and resulted in a lack of participant accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Jan 2020 (actual)
- 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.
Researchers are studying how vein mapping impacts patient outcomes and satisfaction after facial injection procedures.
Detailed description
Facial Botox/filler injections carry risk of puncturing superficial veins, leading to bruising and pain. Our study will investigate the utility of non-invasive vein imaging (specifically near-infrared light reflection) on the incidence of pain/bruising/hematoma and patient satisfaction after facial injections.
The current standard of care for facial injection procedures does not involve any modality of facial venous mapping. Vein mapping is a non-invasive, simple task that takes very little time to conduct. One risk is patient time, however maximum extra time needed will be 5 minutes during the clinical visit. This potential extra time in mind, the benefits far outweigh the risks.
Two cohorts of patients will be prospectively compared following randomization, those who did have pre-procedure venous mapping prior to injection versus those who did not. Data will be analyzed with regard to bruising and swelling following injection, as well as other potential complications such as hematoma or infection, along with patient satisfaction survey information.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Goup | No intervention | –Subjects will undergo clinically indicated facial injection procedures per standard of care without venous mapping |
| Intervention Group | Experimental | Device: Accuvein® VeinfinderSubjects will undergo clinically indicated facial injection procedure with pre-procedural facial venous mapping by Accuvein® Veinfinder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients pursuing aesthetic/therapeutic facial injection procedures (botox/filler)
Key exclusion criteria (1 listed)
- Patients undergoing aesthetic facial procedures not requiring needle injection
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 |
|---|---|---|
| Accuvein® VeinfinderNear-infrared light reflection utilized by healthcare providers to see superficial veins under the skin. | Device | Intervention Group |
Primary outcome
Patient satisfaction
Time frame: Approximately 7-10 days following the procedure
Measured using the self-reported FACE-Q satisfaction score, using a scale of 1=definitely disagree and 4=definitely agree
1 secondary outcome
Rate of Bruising/Hematoma
Time frame: Approximately 7-10 days following the procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
William Casey III, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Accuvein® Veinfinder in people with Wrinkle, run by Mayo Clinic.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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: Approximately 7-10 days following the 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 1 May 2024.