Trial document





This trial has been registered retrospectively.
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  DRKS00017646

Trial Description

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Title

Evaluation of the single use URS PU3022 from PUSEN in patients with stone disease

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Trial Acronym

[---]*

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URL of the Trial

http://no own available

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Brief Summary in Lay Language

Nowadays, kidney stones are treated often by endourological intervention, depending on the size and localization of the stones. For this, fine instruments with a camera are used. These endoscopes can detect and treat nearly every stone in the kidney. In the case, the stone is too big for removing it out; the stone is fragmented with a special laser and removed with a stone basket out of the kidney. In daily clinical practice, instruments from the 3rd generation (fiberoptic instruments) and 4th generation (video-instruments) are used. A huge problem are the repair costs of the reusable instruments, because of sterilization process and multiple usage. Additionally even when they are sterilized after every operation, a contamination can`t be excluded for 100%. For a short time, there are new instruments on the market, which are single-use instruments. If these instruments are comparable with the reusable instruments and if the single-use instruments fulfill the high requirements is matter of the ongoing debate.
Aim of this study is, to evaluate the new single-use instrument PU3022 (from PUSEN) in patients with kidney stones and to compare them with the reusable instruments. Primarily, factors like the handling, the flow rate, the visibility and the constant of the all operation time are evaluated. Directly after the intervention the operator has to evaluate with a specific grading system. Every patient with a kidney stone can be included in the study, suppositional he fulfills all the inclusion criteria.

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Brief Summary in Scientific Language

Since the introduction of endoscopic instruments, instruments of the third and fourth generation can detect and treat nearly every stone in the kidney. This intervention is for diagnostic, to get histology and most often for the treatment of kidney stones with or without a laser. (The laser is used in the case stones have to be fragmented and can`t be removed because of their size). Factors like optical conditions, the flow rate, the flection with or without assistive devices (stone baskets and laser fibers) and the handling of the instruments are very important factors. For the treatment of stones in the ureter, semirigid instruments are used. Beside this, for treatment of stones in the pelvis of the kidney flexible instruments are used. In instruments of the 4th generation, the camera and the source of the light are in the tip of the instrument. Clinical studies have shown, that the allover operating time is faster with instruments of the 4th generation because of the high resolution compared to the fiberoptic instruments (3rd generation) [1, 2].
Although the newer instruments are not so susceptible to failure compared to the elderly instruments, it has was shown that because of sterilization and multiple usage the number of instruments, which have to be repaired, is tremendous high. This was shown in the vast costs for reparation.
Within the help of the single-use instruments, the quality of the reusable instruments should be ensured and the costs for sterilization and the repair costs should be reduced. Data of a study from Dale et al. have shown that the optical performance, the flection behavior and the irrigation flow of the single-use URS (LithoVue from Boston Scientific) is comparable to instruments of the 4th generation and that the field of view was highest in the single-use instrument [3].
How far there is a clinical benefit in using single-use instruments in daily clinical practice is not adequate evaluated.
Hypothesis and aim of the study:
Within the help of URS-instruments, nearly all stones in the upper urinary tract can be detected and treated. Requirement for this are instruments, which offer a very good visibility and flection. The quality of the integrated camera and the flow rate influence the visibility. There is no enough evidence if the single-use instruments, available on the market, are comparable with the reusable instruments in endourological procedure.
Aim of this study is, to evaluate the single-use instrument from PUSEN in the treatment of kidney stones, and to compare them with the performance of reusable instruments and further to evaluate if these instruments fulfill these high requirements.

1. Binbay, M., et al., Is there a difference in outcomes between digital and fiberoptic flexible ureterorenoscopy procedures? J Endourol, 2010. 24(12): p. 1929-34.
2. Somani, B.K., et al., Outcomes of flexible ureterorenoscopy and laser fragmentation for renal stones: comparison between digital and conventional ureteroscope. Urology, 2013. 82(5): p. 1017-9.
3. Dale, J., et al., Evaluation of a Novel Single-Use Flexible Ureteroscope. J Endourol, 2017.

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Organizational Data

  •   DRKS00017646
  •   2019/08/02
  •   [---]*
  •   yes
  •   Approved
  •   17-533, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   N20.0 -  Calculus of kidney
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Interventions/Observational Groups

  •   Group treated with single use URS
  •   Group treated with Video URS
  •   Group treated with fiberoptic URS
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint is to evaluate the impact of the visibilty, flection and the handling of the instruments. This should be done with and without assistive divices. It should be directly after the operation by the operateur.

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Secondary Outcome

Time of operation, the stone free rate and the necessity of reintervention should be evaluated for secondary endpoints.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/01/22
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion citeria:
Patients with kidney stone(s), which can not be treated with a semiregide URS
no contarindication for anaesthesiology
age older 18
signed a informed consent
no psychiatric diseases
no other diseases as contraindication for an endourology intervention

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Exclusion Criteria

contraindication for anaesthesiology
age younger than 18
urinary tract infection
not willing to signed informed consent
pragnent
psychiatric diseases

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Urologische Poliklinik und Klinik der LMU München
    • Mr.  PD Dr.  Frank  Strittmatter 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • LIFE - ZentrumLMU München
    • Mr.  PD Dr.  Ronald  Sroka 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Urologische Klinik und Poliklinik der LMU München
    • Mr.  PD Dr.  Frank  Strittmatter 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Urologische Poliklinik und Klinik der LMU München
    • Mr.  PD Dr.  Frank  Strittmatter 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Urologische Klinik und Poliklinik der LMU München
    • Mr.  PD Dr.  Frank  Strittmatter 
    • 81377  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/09/30
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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.