NCT04690803

The Effect of Cooling on Sclerotherapy Efficacy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Leg Veins

Interventions

Type	Name	Description
DRUG	air cooling	intervention is adding air-cooling to treatment

Timeline

• Start date: 2020-01-06
• Primary completion: 2022-01-01
• Completion: 2022-12-01
• First posted: 2020-12-31
• Last updated: 2021-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study