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Efficacy and Safety Evaluation of Changes in Lower Extremity Edema of Radiofrequency

NCT05185193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-01-11

No results posted yet for this study

Summary

The purpose of this study is to verify the efficacy and safety of the radiofrequency stimulation compared to the sham stimulation in reducing lower extremity edema in adult women with idiopathic edema.

Conditions

  • Idiopathic Edema

Interventions

DEVICE

radiofrequency

Radiofrequency of 9.50v, 218.5mA and 2.076W is applied once a day for 30 minutes, a total of 3 times

DEVICE

sham stimulation

The appearance is the same as the medical device for clinical trials, and when applied, the sound and the amount of light visible from the outside are designed to be the same as the medical device for clinical trials. The external light was the same, and only the high frequency that stimulates the dermis was blocked. The sham device was applied once a day for 30 minutes, a total of 3 times.

Sponsors & Collaborators

  • Pusan National University Yangsan Hospital

    lead OTHER

Principal Investigators

  • Young-Il Shin · Pusan National University Yangsan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
72 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-04-21
Completion
2021-05-21

Countries

  • South Korea

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 NCT05185193 on ClinicalTrials.gov