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Microwave Ablation in Mild Axillary Hidradenitis Suppurativa

NCT03238469 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-06-25

No results posted yet for this study

Summary

With microwave ablation (MWA), using the heat generated from electromagnetic waves in the microwave energy spectrum, hair follicles and apocrine glands in the (hypo)dermis are ablated through thermolysis. MWA was recently approved for the treatment of axillary hyperhidrosis (miraDry) and removal of axillary hair (miraSmooth). By permanent removal of hairs and sweat glands, the investigators hypothesize a beneficial and long-term sustainable preventive effect of MWA in HS patients.

Conditions

Interventions

DEVICE

Microwave ablation

A one-sided (either right or left axillary area) single MWA treatment using a miraDry system. The miraDry device has a microwave output frequency of 5.8 GHz and microwave energy level settings ranging from 1 to 5, corresponding with a delivery time in seconds between 2.40 sec and 3.00 sec. For this study standard 5 (i.e. 3.00 sec) is set as treatment setting.

Sponsors & Collaborators

Principal Investigators

  • Errol Prens, MD, PhD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-04-01
Completion
2018-04-01
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

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 NCT03238469 on ClinicalTrials.gov