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Dermal Profile Analysis Using the NMR-MOUSE (SHN)

Primary Purpose

Exposure to Magnetic Field, Hypotension During Dialysis, Disturbance; Balance, Fluid

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dermal nuclear magnetic resonance (NMR)-profile measurement
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Exposure to Magnetic Field

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital of RWTH Aachen, Department of Medicine II

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dialysis patients

Healthy volunteers

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Measurement of the diffusion coefficient D [m²/s] by NMR-MOUSE in dialysis patients and healthy volunteers
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2016
Last Updated
March 23, 2021
Sponsor
RWTH Aachen University
Collaborators
Institute for Technical and Macromolecular Chemistry, RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT02934009
Brief Title
Dermal Profile Analysis Using the NMR-MOUSE
Acronym
SHN
Official Title
Dermal Profile Analysis Using NMR-MOUSE (Nuclear Magnetic Resonance - Mobile Universal Surface Explorer)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Study Start Date
October 2016 (Actual)
Primary Completion Date
May 8, 2020 (Actual)
Study Completion Date
May 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
Collaborators
Institute for Technical and Macromolecular Chemistry, RWTH Aachen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exposure to Magnetic Field, Hypotension During Dialysis, Disturbance; Balance, Fluid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialysis patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dermal nuclear magnetic resonance (NMR)-profile measurement
Other Intervention Name(s)
NMR-MOUSE
Intervention Description
Nuclear magnetic resonance (NMR)-profile measurement of the dermis
Primary Outcome Measure Information:
Title
Measurement of the diffusion coefficient D [m²/s] by NMR-MOUSE in dialysis patients and healthy volunteers
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of NMR-Mouse dermal measurement
Description
The overall number of participants with treatment-related adverse events during the study will be investigated.
Time Frame
30 minutes
Title
Time needed for NMR-Mouse dermal measurement
Description
The overall time needed to measure each participant of the study will be documented.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Floege, M.D.
Organizational Affiliation
RWTH Aachen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of RWTH Aachen, Department of Medicine II
City
Aachen
State/Province
NRW
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15975840
Citation
Perlo J, Casanova F, Blumich B. Profiles with microscopic resolution by single-sided NMR. J Magn Reson. 2005 Sep;176(1):64-70. doi: 10.1016/j.jmr.2005.05.017.
Results Reference
background
PubMed Identifier
23290626
Citation
Danieli E, Blumich B. Single-sided magnetic resonance profiling in biological and materials science. J Magn Reson. 2013 Apr;229:142-54. doi: 10.1016/j.jmr.2012.11.023. Epub 2012 Dec 8.
Results Reference
background
PubMed Identifier
16580238
Citation
Perlo J, Casanova F, Blumich B. Single-sided sensor for high-resolution NMR spectroscopy. J Magn Reson. 2006 Jun;180(2):274-9. doi: 10.1016/j.jmr.2006.03.004. Epub 2006 Mar 31.
Results Reference
background
PubMed Identifier
20404719
Citation
Medrano G, Eitner F, Floege J, Leonhardt S. A novel bioimpedance technique to monitor fluid volume state during hemodialysis treatment. ASAIO J. 2010 May-Jun;56(3):215-20. doi: 10.1097/MAT.0b013e3181d89160.
Results Reference
background
PubMed Identifier
15611362
Citation
Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ; Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005 Jan;45(1):142-61. doi: 10.1161/01.HYP.0000150859.47929.8e. Epub 2004 Dec 20.
Results Reference
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Dermal Profile Analysis Using the NMR-MOUSE

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