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Microwave Therapy

Microwave Treatment for Actinic Keratosis

N/A
Recruiting
Led By Professor Dirschka
Research Sponsored by Blackwell Device Consulting
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
There must be at least 2 AK lesions on the left and right side of the scalp or left and right hand
Agrees to refrain from using any other Actinic Keratosis products or treatments during the study period, unless specified by the Investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2, 4 and 6 months post first treatment
Awards & highlights

Study Summary

This trial will compare a treatment for Actinic Keratosis, where each subject acts as their own control, in two different countries. 60 people will be studied, with 51 completing the trial.

Who is the study for?
This trial is for adults with Actinic Keratosis lesions on their scalp or hands. Participants must have an even number of lesions (10, 12, or 14) and agree not to use other AK treatments during the study. Exclusions include pregnancy, breastfeeding, recent participation in another trial, certain medical conditions like skin cancer history or immunosuppression, and metal implants at treatment sites.Check my eligibility
What is being tested?
The Swift System microwave treatment for Actinic Keratosis is being tested. Each participant serves as their own control in this randomized study across two sites—one in Germany and one in the U.S.—aiming for 51 completions from about 60 participants.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include discomfort at the treatment site, skin reactions such as redness or swelling, and possible allergic reactions to microwave therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least 2 AK lesions on both sides of my scalp or hands.
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I agree not to use any Actinic Keratosis treatments not approved by the study.
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I agree to stop my Actinic Keratosis medication 28 days before the study starts.
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I can participate in all required study check-ups and tests.
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I have 10 to 14 AK lesions on either my scalp or hands, not both.
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I don't have any health conditions that would risk my safety in the study.
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I am between 18-85 years old (EU) or 22-85 years old (US).
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I am willing and able to follow all study rules and attend all appointments.
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My cancer is located on the skin.
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I agree not to use any metallic or ionic skin treatments during the study.
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I have been diagnosed with precancerous Actinic Keratosis by a dermatologist.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2, 4 and 6 months post first treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 4 and 6 months post first treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects with treatment success of Actinic Keratosis at 2 months following Swift Microwave treatment.
Secondary outcome measures
Difference in cosmetic outcomes between treated and non-treated Actinic Keratosis as classified by the independent blinded assessors using a grading system
Duration of pain after treatment using a time period scale
Evaluation of Cosmetic Outcome at 6 months post first treatment using a rating scale
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Microwave Treatment (Swift System)Experimental Treatment1 Intervention
3-4 Watts applied locally for up to a 3 second burst to each AK lesion, repeated 3 times per lesion. Burst is defined as a single delivery of microwave energy. There will be approximately 20 seconds between each repeat dose.
Group II: No TreatmentActive Control1 Intervention
No Treatment administered

Find a Location

Who is running the clinical trial?

Emblation LimitedIndustry Sponsor
3 Previous Clinical Trials
187 Total Patients Enrolled
Blackwell Device ConsultingLead Sponsor
1 Previous Clinical Trials
124 Total Patients Enrolled
Professor DirschkaPrincipal InvestigatorCentroDerm GmbH, Heinz-Fangman-Strasse 57, 42287 Wuppertal (Barmen), Germany

Media Library

Swift System (Microwave Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05636800 — N/A
Actinic Keratosis Research Study Groups: Microwave Treatment (Swift System), No Treatment
Actinic Keratosis Clinical Trial 2023: Swift System Highlights & Side Effects. Trial Name: NCT05636800 — N/A
Swift System (Microwave Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05636800 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for trial participants broadened to incorporate individuals 45 years and older?

"According to the study parameters, only those 18-85 years old can join this trial. 2 spots are designated for minors and 25 openings have been made available for people aged 65 or more."

Answered by AI

Could I potentially qualify for this research project?

"In order to be eligible for this study, potential participants must have actinic keratosis and should range between 18-85 years old. The program is looking to accept 60 candidates in total."

Answered by AI

Is enrollment for this trial ongoing?

"Indeed, the clinical trial is actively recruiting as per information available on clinicaltrials.gov. This medical experiment was first announced on January 18th 2023 and has since been modified in content or structure most recently on January 19th of the same year."

Answered by AI

What is the current participation rate of this medical experiment?

"Affirmative. As indicated by information on clinicaltrials.gov, this medical research is currently recruiting test subjects. The trial was first posted in January of 18th 2023 and the last update was made a day later; there are 60 patients that need to be recruited from one site."

Answered by AI
~28 spots leftby Mar 2025