NCT03107065

Single-Treatment, Study of Percutaneous-Temperature Controlled-RF Electrocoagulation on Axilla Tissue

A Pilot, Open-Label, Single-Center, Single-Treatment, Safety And Effectiveness Evaluation Of Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation Used To Contract Tissue Associated With Axillary Sweat Glands

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ThermiGen, LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a pilot, open-label, and single-center, single-treatment prospective evaluation of the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to improve excessive sweating of the axilla(s). In this study, "Temporary Relief" is defined as improvement on the DLQI. Twenty male and female subjects between 18 and 50 years old will be enrolled. A total of five visits are planned for this study. A punch biopsy will be collected (prior to and post treatment and analyzed to determine the degree of impact to the tissue after the electrocoagulation treatment. Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale, and adverse events reports (observed or reported). The total length of the study is approximately 4 months.

Detailed description

This is a pilot, open-label, and single-center, single-treatment prospective evaluation of the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to alleviate or improve symptoms associated with axillary sweating. In this study, "Temporary Relief" is defined as improvement on the DLQI. A total of 20 male and female healthy volunteers between the age of 18 and 50 will be enrolled in this study. Subjects who sign the informed consent form and meet all entry criteria will be assigned a unique number/code to preserve confidentiality. A total of five visits are planned for this study as described below: * Visit 1: Screening visit - (Day 0) * Visit 2: Single Treatment * Visit 3: Day 30 (± 7 days) * Visit 4: Day 60 (± 7 days) * Visit 5: Day 90 (± 7 days) A punch biopsy will be collected at Visit 1(screening), Visit 2 (post-treatment) and Visit 4 (Day 60). The purpose of the punch biopsy is to evaluate the degree of impact to the axillary organ after the electrocoagulation treatment when compared to pre-treatment at Visit 1. Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale, and adverse events reports (observed or reported). The total length of the study is approximately 4 months.

Conditions

• Sweating Increased Armpits

Interventions

Type	Name	Description
DEVICE	Thermi Radiofrequency	Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation

Timeline

• Start date: 2016-12-08
• Primary completion: 2017-07-01
• Completion: 2017-09-06
• First posted: 2017-04-11
• Last updated: 2017-12-20

Locations

1 site across 1 country: United States