NCT01547403

Customer Support Response Study

Evaluation of Customer Support Issues, Questions, or Alleged Complaints Regarding Use of Approved Commercially Distributed Scout DS Product in the Field

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: VeraLight, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the CUSTOM study is to respond to customer support issues (outside of the US) and to assess the impact of a particular treatment or perturbation relative to an initial control measurement. Sequential subject measurements will be analyzed to determine if a given action or condition induces a score shift, an inflation of measurement variance or elevated outlier rates.

Detailed description

The SCOUT DS device is not yet approved by the FDA for sale in the United States, but currently is being marketed in Canada and other countries. Customers who are using the device have contacted the sponsor with questions about testing conditions which might affect the reproducibility of measurements. The objective is to obtain information to allow the Sponsor to address these issues. The concerns fall into three broad categories: • Factors affecting the interface between the skin and the test sensor These would include the effects of skin care products applied to the forearm, subject activity that changes perfusion to the skin and subject movement during the test procedure. * General operating conditions Issues such as ambient temperature, lighting, and height of the table on which the SCOUT DS device rests have been questioned as possible factors influencing accuracy. * Rare subject disorders Included here would be subject skin abnormalities or physiologic changes which occur so infrequently that they were not well represented in previous data sets. Examples of such rare conditions would include scleroderma, capillary angiomata, and Raynaud phenomenon.

Conditions

• Type 2 Diabetes

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-03-07
• Last updated: 2013-01-15

Locations

1 site across 1 country: United States