Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-15 @ 11:06 PM
Study NCT ID:
NCT01833156
Status:
COMPLETED
Last Update Posted:
2013-06-11
First Post:
2013-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the MoistureMeterD in Local Edema by Histamine
Sponsor:
Nij Smellinghe Hosptial
Organization:
Study Overview
Official Title:
A Clinimetric Research to Test the Validity of the MoistureMeterD, Conducted by the Local Edema (Urticaria Acuta) Into the Administering of Intradermal Histamine.
Status:
COMPLETED
Status Verified Date:
2013-06
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:
In lymphedema there is increase in water content of the tissue. We studied a device (MoistureMeterD) which is suitable to detect water contact in the tissue. Although the apparatus is commercially available, no validation study had been performed in vivo with local edema.
We designed a validation study for inter- and intra observer variability and the reproducibility in vivo by histamin induced local edema
We designed a validation study for inter- and intra observer variability and the reproducibility in vivo by histamin induced local edema
Detailed Description:
The multiprobe Delfin MoistureMeterD is a unique and compact water-specific instrument for the measurement of water content of biological tissues. It measures the dielectric constant values of the skin and subcutaneous tissues non-invasively and locally in a few seconds. The dielectric constant value is directly proportional to the amount of water in the tissue.
As lymphedema produces local water content increase, we are interested if the device is suitable for daily use in lymphedema patients. Therefore we designed a protocol to measure the results with a moisturemeter in a standardized edema formation by histamin induced scratch test edema. This method is well known in type I allergy testing.
The aim of the study is:
1. research the inter- and intra observer variability
2. measure the reproducibility of edema formation in a standardized edema formation
As lymphedema produces local water content increase, we are interested if the device is suitable for daily use in lymphedema patients. Therefore we designed a protocol to measure the results with a moisturemeter in a standardized edema formation by histamin induced scratch test edema. This method is well known in type I allergy testing.
The aim of the study is:
1. research the inter- and intra observer variability
2. measure the reproducibility of edema formation in a standardized edema formation
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?: