- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01547403
Customer Support Response Study (CUSTOM)
Evaluation of Customer Support Issues, Questions, or Alleged Complaints Regarding Use of Approved Commercially Distributed Scout DS Product in the Field
Study Overview
Status
Conditions
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.
Study Type
Contacts and Locations
Study Locations
-
-
New Mexico
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Albuquerque, New Mexico, United States, 87106
- VeraLight
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Males and/or females greater than or equal to 18 years of age
Exclusion Criteria:
- Have received investigational treatments in the past 14 days
- Have psychosocial issues that interfere with an ability to follow study procedures
- Are known to be pregnant
- Have scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
- Have been treated on the past month with oral steroid therapy or topical steroids applied to the left forearm. Inhaled steroid therapy is not a basis for exclusion
- Are receiving medications that fluoresce (A list of excluded medications is located in Appendix H)
- Are known to have, or at risk for, photosensitivity reactions (e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Endpoint for CUSTOM Trial
Time Frame: Up to 1 year
|
The primary objective of the CUSTOM study is to respond to customer support issues 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. Subjects will undergo measurements and a diabetes risk score is generated from the SCOUT device. The scale of the score is 0-100. Subjects are not provided with this score as the device is still investigational in the US. |
Up to 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jon Aase, MD, VeraLight, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VL-2719
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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