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

NCT03107065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-12-20

No results posted yet for this study

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.

Conditions

  • Sweating Increased Armpits

Interventions

DEVICE

Thermi Radiofrequency

Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation

Sponsors & Collaborators

  • ThermiGen, LLC

    lead INDUSTRY

Principal Investigators

  • Toni Fournier · ThermiGen, LLC

  • Kevin O'Brien · ThermiGen, LLC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-08
Primary Completion
2017-07-31
Completion
2017-09-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03107065 on ClinicalTrials.gov