Dermal Profile Analysis Using the NMR-MOUSE (SHN)

March 23, 2021 updated by: RWTH Aachen University

Dermal Profile Analysis Using NMR-MOUSE (Nuclear Magnetic Resonance - Mobile Universal Surface Explorer)

The determination of fluid status in dialysis patients is a major clinical problem. In this study the NMR-MOUSE is used to determine if it can be used to non-invasively determine hydration status of the skin. This evaluation will be performed in dialysis patients and healthy volunteers.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Excretion of urine is impaired in terminal chronic kidney disease patients often requiring dialysis. Fluid management of dialysis patients is solely based on body weight differences before and after dialysis. Patients can suffer from either hypotension if too much fluid is eliminated by dialysis or from fluid-overload symptom (e.g. shortness of breath, edema) if not enough fluid is eliminated.

In this study a mobile non-invasive NMR-MOUSE setup (a nuclear magnetic resonance spectroscopy measurement) is used to measure the hydration status of the skin.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany
        • University Hospital of RWTH Aachen, Department of Medicine II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-80
  • Dialysis
  • ability to perform NMR-measurement
  • Eligibility to sign informed consent
  • signed informed consent

Exclusion Criteria:

  • implanted cardiac device
  • implanted cranial device
  • implanted cochlea device
  • intrauterine device
  • other metallic implants
  • tattoo, any skin disease or scars from surgery (in the area of measurement)
  • previous skin treatment with cosmetics (of any kind) 24 hours prior to measurement
  • wearing of earrings, piercings or hearings-aids during measurement
  • participation in other clinical trials 30 days prior to participation in the SHN study
  • no written informed consent
  • any conditions, as determined by the examiner, that excludes the patient from participation in the study
  • subjects with legal guardian
  • pregnancy or lactation (a possible pregnancy of a participant before menopause will be excluded before inclusion in the study)
  • subjects under employment or with any relation to the the sponsor or the investigator
  • participation in any other study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dialysis patients
In this group dialysis patients are measured by NMR-Mobile Universal Surface Explorer® (NMR-Mouse) during their routine dialysis sessions. After a 5 min rest period the arm of the patients is placed onto the NMR-Mouse and measured before the beginning of dialysis. The arm examined is not the shunt arm. The area selected should not display any signs of skin disease or scars from previous surgeries. After the dialysis the same area is measured again in a second measurement. The measurement will be repeated on three different days with each patient.
Device: Dermal nuclear magnetic resonance (NMR)-profile measurement
Nuclear magnetic resonance (NMR)-profile measurement of the dermis
Other Names:
  • NMR-MOUSE
Experimental: Healthy volunteers
In this group "kidney-healthy" volunteers will be examined by NMR-Mobile Universal Surface Explorer® (NMR-Mouse) at three different days. The right/left arm or leg will be used for repeated measurement. Altogether 2 measurements per day are reformed in order to evaluate the reproducibility and variability.
Device: Dermal nuclear magnetic resonance (NMR)-profile measurement
Nuclear magnetic resonance (NMR)-profile measurement of the dermis
Other Names:
  • NMR-MOUSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the diffusion coefficient D [m²/s] by NMR-MOUSE in dialysis patients and healthy volunteers
Time Frame: 30 minutes
The skin will be subjected to a weak magnetic field (B0). The transversal relaxation time T2 [in s] will be measured stepwise in mm (millimeter) profiles for up to 16 mm depth in the skin. From the different measurements per profile of the skin a diffusion coefficient D [m²/s] will be calculated, which changes dependent on the hydration status of the skin.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NMR-Mouse dermal measurement
Time Frame: 30 minutes
The overall number of participants with treatment-related adverse events during the study will be investigated.
30 minutes
Time needed for NMR-Mouse dermal measurement
Time Frame: 30 minutes
The overall time needed to measure each participant of the study will be documented.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Collaborators

Institute for Technical and Macromolecular Chemistry, RWTH Aachen University

Investigators

  • Principal Investigator: Jürgen Floege, M.D., RWTH Aachen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

May 8, 2020

Study Completion (Actual)

May 8, 2020

Study Registration Dates

First Submitted

September 30, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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