Viewing Study NCT01342133


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Study NCT ID: NCT01342133
Status: COMPLETED
Last Update Posted: 2012-06-28
First Post: 2011-04-22
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Sweat Duct Imaging in Mother/Newborn Dyads
Sponsor: Edimer Pharmaceuticals
Organization:

Study Overview

Official Title: Sweat Duct Imaging in Mother/Newborn Dyads
Status: COMPLETED
Status Verified Date: 2012-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device.
Detailed Description: In this exploratory study, the investigators propose to evaluate sweat duct number on the plantar surface of newborn infants using a non-invasive confocal microscopy device (Lucid Vivascope®). This approach has the potential to be valuable in repeated sweat endpoint assessments, as the device was selected based on its ease of use, the low risk to patients of all ages, and its ability to generate quantitative data.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: