NCT05636800

Microwave Treatment for Actinic Keratosis

Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment for Actinic Keratosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Blackwell Device Consulting · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, multi-center trial in subjects diagnosed with Actinic Keratosis (AK) where each subject serves as their own control. The trial will be conducted at 2 sites, one in Germany and one in the United States. Approximately 60 subjects will be randomized to ensure 51 subjects complete the study.

Detailed description

The primary objective of this trial is to evaluate the efficacy of the Swift Microwave Treatment on resolution of Actinic Keratosis lesions. The secondary objectives of this trial is to evaluate the efficacy, safety and tolerability of Swift Microwave treatment as a therapy for Actinic Keratosis (AK). Eligible subjects who provide written informed consent and have 10, 12 or 14 distinct Actinic Keratosis lesions located on their scalp or hands will be randomized onto the study. Randomization of AK lesions will be stratified by side. Subjects will be randomized to treatment on half the number of AK lesions mapped located on their scalp or hands. The mapped AK lesions not randomized for treatment will receive no treatment (control). The microwave energy applied by the Swift device will be applied to the randomized AK lesion sites for up to 2 treatments, spaced out by a 4-week interval. Follow-up is 2-months after the first treatment is administered where the AK lesions are assessed for resolution. Further follow-up visits occur at 4-months, 6-months and 12-months after the first treatment was administered where the AK lesions will be assessed for resolution or reoccurence.

Conditions

• Keratosis, Actinic

Interventions

Type	Name	Description
DEVICE	Swift System	Localized microwave energy applied to the distinct AK lesion. Each subject will receive treatment for a maximum of 2 visits (4-week interval between treatment). For AK lesions assessed as "Thin" AK (Olsen Grades 1 and 2): Set at 3W and apply locally for up to a 3 second burst and adjust the dose and duration. Repeat on the same AK lesion as is tolerable for the subject (3 repetitions). There will be approximately 20 seconds between each repeat dose. For AK lesions assessed as "Thick" AK (Olsen Grade 3): Set at 4W and apply locally for up to a 3 second burst and adjust the dose and duration. Repeat on the same AK lesion as is tolerable for the subject (3 repetitions). As the AK lesions may be larger than 3mm in diameter, the dose administered to one AK lesion may require overlapping applications with the applicator tip. Ensure there is approximately 20 seconds between each repeat dose administered

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2022-12-05
• Last updated: 2024-08-06

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study