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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03566381
Other study ID # SX01262018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2018
Est. completion date August 9, 2021

Study information

Verified date June 2022
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pilot study of a soft, flexible wearable sweat sensor


Description:

Assessment of safety, and preliminary accuracy of a sweat sensor capable of operating underwater.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date August 9, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - No history of medical or surgical problems - Age >18 years old - Subjects willing and able to comply with requirements of the protocol Exclusion Criteria: - Age <18 years old - Subjects unwilling and able to comply with requirements of the protocol - History of skin allergy to medical adhesive tape

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Application of a soft patch composed of medical-grade silicone that collects sweat during a subject's natural behaviors.
This device contains sweat sensors embedded in an elastomer and is applied to the skin with a medical grade adhesive.

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adhesion of device underwater Percentage of devices which remain adhered during >1 hr swim trials 2 hours
Secondary Correlation between local and global sweat loss Percentage agreement of local sweat rate with body weight loss 2 hours
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