Trial document





This trial has been registered retrospectively.
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  DRKS00004561

Trial Description

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Title

Raman spectroscopy: Setup of an experimental system for analysis of urinary stone composition

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Trial Acronym

Ramalith

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The prerequisite for an effective prevention of urolithiasis recurrence is the analysis of urinary stone composition as well as the metabolic evaluation. This is needed before a targeted therapy to eliminate the lithogenic risk factors is initiated. Currently urinary stones are analysed infrarotspektrally, radiologically and chemically in special laboratories. This requires a high staff commitment, financial resources and is time consuming. This study could show that the development of a Raman spectroscopy based, compact and portable system for composition analysis of urinary stones is feasible. In term of a better prevention of urolithiasis recurrence, a significant improvement of medical care for urolithiasis patients might be expected.

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Brief Summary in Scientific Language

Analysis of urinary stone composition provides basic information concerning treatment and metaphylaxis of urolithiasis. Common techniques for composition analysis include chemical analysis, infrared spectroscopy and x-ray diffraction. These standard techniques afford complex sample preparation and costly laboratory equipment. Raman spectroscopy has been shown to be able to precisely identify the different components of urinary stones. Fibre-coupled Raman spectrometers might offer possibilities for the development of an easy to use tool for intraoperative stone analysis during ureteroscopic stone treatment. In this study, pure samples will be analysed by Raman spectroscopy using a microscope-coupled system at different excitation wavelengths. Accuracy of the acquired spectra, compromising background effects such as fluorescence and signal to noise ratio will be determined and compared. Laser-induced Raman spectroscopy proved to be a reliable technique to adequately identify urinary stone composition. It is expected, that this pilot study will provide essential information for the construction of a fibre-coupled system for immediate stone analysis during urinary stone therapy.

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Organizational Data

  •   DRKS00004561
  •   2012/11/27
  •   [---]*
  •   yes
  •   Approved
  •   220/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Urolithiasis
  •   N20 -  Calculus of kidney and ureter
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Interventions/Observational Groups

  •   Spectra aquisition of pure samples and native patients stones for system calibration and other spectral analysis. Following testing for an automated components detection in native samples and validation to conventional infrared spectroscopy.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

An automated spectral composition analysis of human urinary based on Raman spectroscopy is feasible?

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Secondary Outcome

Technical construction of a portable Raman spectrometer with an option for potential clinical implementation is feasible?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/29
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

All patients, in which a urinary stone was obtained for examination during the treatment of urinary stone disease

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Exclusion Criteria

no consent on the use of urinary stone for scientific purposes

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Addresses

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    • Uniklinikum Freiburg Chirurgische Universitätsklinik Abteilung für Urologie
    • Mr.  Prof. Dr.  Ulrich  Wetterauer 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Mr.  Dr.  Armin  Lambrecht 
    • Heidenhofstraße 8
    • 79110  Freiburg
    • Germany
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    • Uniklinikum Freiburg Chirurgische Universitätsklinik Abteilung für Urologie
    • Mr.  Dr.  Arkadiusz  Miernik 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Uniklinikum Freiburg Chirurgische Universitätsklinik Abteilung für Urologie
    • Mr.  Dr.  Arkadiusz  Miernik 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinikum Freiburg Chirurgische Universitätsklinik Abteilung für Urologie
    • Mr.  Prof. Dr.  Ulrich  Wetterauer 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting suspended on temporary hold
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.