Ignite Creation Date:
2024-07-17 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497764
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma PRP
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Pilot Randomized Non-blinded Single-center Study of the Efficacy of a Vibrational Anesthesia VA Device on Reducing Pain During Platelet Rich Plasma PRP Scalp Treatment for Alopecia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is prospective single-site randomized split-scalp pilot and survey study of patients at the NYU Skin and Cancer Clinic or the Faculty Group Practice The investigators will randomize half of the scalp of each patient one half will receive vibrational anesthesia VA via a device and the other half will not Approximately 100 unique patients will be recruited there will only be one study group During the standard of care platelet rich plasma PRP procedure a REDCap survey questionnaire will be provided asking the patients to rate their pain with the visual analogue scale VAS A simple paired t-test will be used to test significant improvement in pain scores between the two halves of the scalp
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
True
Is a US Export?:
False
Is an FDA AA801 Violation?:
None