NCT02919007

Silk'n HST Device Usability and Self Selection Study

Clinical Evaluation of Silk'n HST Self-selection, Labeling Comprehension, and Device Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Home Skinovations Ltd. · Industry
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Accepted

Summary

This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.

Detailed description

Study objectives: To test the Silk'n HST Device usability, i.e., the self-selection, labeling comprehension, and safe and effective device use by potential end users, under actual use conditions. Additionally, this study was aimed to evaluate if contraindicated subjects self-exclude from use of the device. Investigation Design: The study is a usability study. Twenty five potential participants were enrolled in a single location (shopping mall). Participants received the Silk'n HST device in its original package with the complete user manual and performed a full treatment. Post-treatment questionnaire and labeling comprehension exam were conducted following treatment. Out of the twenty five subjects five participants contraindicated to the study inclusion criteria were self-exclude from use of the device. Success criteria: Using the device, all 20 tested subjects are able to complete device related tasks, including applying and operating the Silk'n device without assistance in a timeframe of up to one hour and with minimal attempts to ask for assistance. Additionally, measurable usability criteria for specific, critical steps, such as time-to-completion, frequency of attempts to ask examiner, numerical ratings, etc., were evaluated using observer evaluation and user post-test questionnaire responses. Sample Size: Twenty five subjects identified as potential end users of the device including five subjects with contraindication to the device were recruited to the study. The number of subjects is appropriate considering the device and user related risks, low probable occurrence and severity of these risks, and the design of the study. Furthermore, usability studies are not seeking statistical significance.

Conditions

• Wrinkles

Interventions

Type	Name	Description
DEVICE	Silk'n HST treatment	Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual

Timeline

• Start date: 2015-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-09-29
• Last updated: 2018-10-31
• Results posted: 2018-09-27