Viewing Study NCT04690803


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Study NCT ID: NCT04690803
Status: UNKNOWN
Last Update Posted: 2021-01-05
First Post: 2020-12-28
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: The Effect of Cooling on Sclerotherapy Efficacy
Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Organization:

Study Overview

Official Title: The Effect of Cooling on Sclerotherapy Efficacy
Status: UNKNOWN
Status Verified Date: 2020-12
Last Known Status: RECRUITING
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: The primary objective of this study is to evaluate the efficacy of sclerotherapy with forced-air cooling during treatment.
Detailed Description: Study Objective: The primary objective of this study is to evaluate the efficacy of sclerotherapy with forced-air cooling during treatment.

Study Design: This will be an investigator-initiated, evaluator-blinded, randomized-controlled, prospective, single-center clinical trial.

Study Population: 20 evaluable subjects with bilateral lower extremity reticular and telangiectatic veins, who meet all study inclusion/exclusion criteria will be considered for entry into the study.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: