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

Size: px

Start display at page:

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

Clyde Riley
8 years ago
Views:

1 PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title Raman spectroscopy: Setup of an experimental system for analysis of urinary stone composition Trial Acronym Ramalith URL of the trial [---]* 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. 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 fibrecoupled system for immediate stone analysis during urinary stone therapy. Page 1 of 5

prerequisite for an effective prevention of urolithiasis recurrence is the analysis of urinary stone composition as well as the metabolic evaluation.

2 Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 220/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg Secondary IDs Health condition or Problem studied Free text: Urolithiasis ICD10: N20 - Calculus of kidney and ureter Interventions/Observational Groups Arm 1: 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. Characteristics Study Type: Non-interventional Study Type Non-Interventional: Other Allocation: Single arm study Blinding: Open (masking not used) Who is blinded: [---]* Control: Other Purpose: Prevention Assignment: Single (group) Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Page 2 of 5

: 220/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg Secondary IDs Health condition or Problem studied Free text: Urolithiasis ICD10: N20 - Calculus of kidney and ureter

3 Primary Outcome An automated spectral composition analysis of human urinary based on Raman spectroscopy is feasible? Secondary Outcome Technical construction of a portable Raman spectrometer with an option for potential clinical implementation is feasible? Countries of recruitment DE Locations of Recruitment University Medical Center Urologie, Freiburg im Breisgau Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2012/05/29 Target Sample Size: 100 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: 90 Years Additional Inclusion Criteria All patients, in which a urinary stone was obtained for examination during the treatment of urinary stone disease Exclusion criteria no consent on the use of urinary stone for scientific purposes Page 3 of 5

Countries of recruitment DE Locations of Recruitment University Medical Center Urologie, Freiburg im Breisgau Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment:

4 Addresses Primary Sponsor Mr. Prof. Dr. Ulrich Wetterauer ulrich.wetterauer at uniklinik-freiburg.de Contact for Scientific Queries Mr. Dr. Arkadiusz Miernik arkadiusz.miernik at uniklinik-freiburg.de Contact for Public Queries Mr. Dr. Arkadiusz Miernik arkadiusz.miernik at uniklinik-freiburg.de Page 4 of 5

Arkadiusz Miernik E-mail: arkadiusz.miernik at uniklinik-freiburg.

5 Collaborator, Other Address Mr. Dr. Armin Lambrecht Heidenhofstraße Freiburg Telephone: [---]* Fax: [---]* armin.lambrecht at ipm.fraunhofer.de URL: Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) Mr. Prof. Dr. Ulrich Wetterauer ulrich.wetterauer at uniklinik-freiburg.de Status Recruitment Status: Recruiting suspended on temporary hold Study Closing (LPLV): [---]* Trial Publications, Results and other documents Please note: There are additional attributes available concerning this trial. To open an extended view please click here.

Ulrich Wetterauer E-mail: ulrich.wetterauer at uniklinik-freiburg.

WAKE-Up Pilot Study, Mental Training for patients with relapse-remitting multiple sclerosis and fatigue

PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title WAKE-Up Pilot Study, Mental Training for patients with relapse-remitting multiple sclerosis and fatigue Trial Acronym