An interventional study of Accuvein® Veinfinder in Wrinkle, sponsored by Mayo Clinic. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
Researchers are studying how vein mapping impacts patient outcomes and satisfaction after facial injection procedures.
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.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will undergo clinically indicated facial injection procedures per standard of care without venous mapping
Subjects will undergo clinically indicated facial injection procedure with pre-procedural facial venous mapping by Accuvein® Veinfinder
Device: Accuvein® Veinfinder
Near-infrared light reflection utilized by healthcare providers to see superficial veins under the skin.
Patient satisfaction
Measured using the self-reported FACE-Q satisfaction score, using a scale of 1=definitely disagree and 4=definitely agree
Time frame: Approximately 7-10 days following the procedure
Rate of Bruising/Hematoma
Number of subjects to experience bruising/hematoma post facial injection procedure
Time frame: Approximately 7-10 days following the procedure
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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