Trial document




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  DRKS00005290

Trial Description

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Title

Pilot trial for the German Endoscopic versus Shock Wave Therapy Study (Pilot-GESS): a randomized controlled trial on interventional treatment of urinary stone disease of the upper urinary tract

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Trial Acronym

Pilot-GESS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This clinical study will compare the present routinely applied treatment options for patients with urinary stones.
Included patients will be randomized and treated with either shock-wave lithotripsy (SWL) or endoscopic procedures ((flexible) ureterenoscopy (f)URS). A follow-up visit 14 days after intervention will be performed. End of trial will be 3 months after intervention.

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Brief Summary in Scientific Language

It is the aim of the pilot study to evaluate the recruitment/ randomization rate and the feasibility of the main study. All study procedural steps of the main study will be featured in the pilot study (randomization procedure, data collection forms, training of staff, etc.). In this sense, the pilot study serves as a dummy run of the trial. The recruitment rate of the study including the number of eligible patients within the planned time frame and the rate of patients’ informed consent will be evaluated. Possible obstacles to a successful recruitment may be detected and procedures will be adapted accordingly. The successful conduct of the pilot study will increase the quality of the planned multicentre trial and the chances to receive funding.

Due to an amendment the number of cases was increased from 40 to 60 (patients).

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Organizational Data

  •   DRKS00005290
  •   2015/08/31
  •   [---]*
  •   yes
  •   Approved
  •   406/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   N20.9 -  Urinary calculus, unspecified
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Interventions/Observational Groups

  •   Part 1: Ureteral calculi: (flexible) uretherrenoscopy (f)URS (experimental)
    Part 2a: Renal calculi ≤ 10 mm (non-lower pole): (flexible) uretherrenoscopy (f)URS (experimental)
    Part 2b: Renal calculi ≤ 10 mm (lower pole): (flexible) uretherrenoscopy (f)URS (experimental)
    Part 3: Renal calculi >10 - 20 mm: (flexible) uretherrenoscopy (f)URS (experimental)
  •   Part 1: Ureteral calculi: shock-wave lithotrypsie (SWL) (control)
    Part 2a: Renal calculi ≤ 10 mm (non-lower pole): shock-wave lithotrypsie (SWL) (control)
    Part 2b: Renal calculi ≤ 10 mm (lower pole): shock-wave lithotrypsie (SWL) (control)
    Part 3: Renal calculi >10 - 20 mm: shock-wave lithotrypsie (SWL) (control)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Recruitment / randomisation rate

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Secondary Outcome

1) Feasibility
2) Stone clearance (CT-controlled) within 3 months (yes, no)
3) Clinical success (stone clearance or CIRF ≤ 4 mm) within 3 months (yes, no)
4) Number of re-treatments of the same modality to achieve stone free status during the 3 months-treatment period (until final control after 3 months)
5) Ancillary procedures
6) Efficiency quotient
7) Operative data (use of anaesthesia, operating time (for primary treatment only))
8) Postoperative data (hospital stays (days, for primary treatment only), number of consultations
9) Use of analgetics (CACS)
10) Patient satisfaction

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/09/18
  •   60
  •   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

Urolithiasis of upper urinary tract (single urinary stone ≤ 20 mm) requiring treatment

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Exclusion Criteria

- Multiple stones at the intended site of treatment
- Renal stones > 20 mm
- Stone not detectable as required for imaging mode of the respective SWL machine in the participating centre (plain radiography (KUB), intravenous ureteropyelography, flouroscopy or sonography)
- Stones with medium density > 1000 HU on NCCT
- Caliceal diverticular stone
- Papillary calcifications (which might be mistaken for residual fragments in final CT)
- Malformation of the kidney or ureter, e.g. horseshoe-kidney, megaureter
- Anatomical obstruction distal to the stone
- Malignant tumour of the kidney or ureter
- Transplant-kidney
- Untreated or recurrent urinary tract infection
- Known coagulation dysfunction or anticoagulation or platelet inhibitors other than acetylsalicylic acid
- Chronic or active infection of any kind, acute arterial hypertension or any other serious uncontrolled medical disorders
- Arterial aneurysm in the vicinity of the stone
- Age < 18 years
- Current or planned pregnancy, nursing period
- Patient without legal capacity who is unable to understand the nature, significance and consequences of the study
- Previous participation (randomization) in this study
- Participation in another interventional clinical trial within the last thirty days before the start of this study
- Simultaneous participation in other interventional trials which could interfere with the trial

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Addresses

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    • Universitätsklinikum Freiburg, Klinik für Urologie
    • Mr.  Dr.  Martin  Schönthaler 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Urologie
    • Mr.  Dr.  Martin  Schönthaler 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Urologie
    • Mr.  Dr.  Martin  Schönthaler 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Albert-Ludwigs-Universität Freiburg, Medizinische Fakultät, Forschungskommission
    • Ms.  Prof. Dr.  Brigitte  Volk-Zeiher 
    • Elsässer Str. 2m
    • 79085  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.