E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elevated pressure in the upper urinary tract during ureterorenoscopy |
Forhøjet tryk i øvre urinveje under ureterorenoskopi |
|
E.1.1.1 | Medical condition in easily understood language |
Elevated pressure in the kidney during endoscopic examination of the kidney and ureter |
Forhøjet tryk i nyren under kikkertoperationer i nyre og urinleder |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023436 |
E.1.2 | Term | Kidney stone |
E.1.2 | System Organ Class | 100000004857 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate if addition of isoprenalin in the irrigation fluid makes access to the upper urinary tract easier during ureterorenoscopy in case of a narrow ureter |
At undersøge om tilsætning af isoprenalin i skyllevæsken under ureterorenoskopi gør adgangen til øvre urinveje lettere i tilfælde af en snæver/ svært passabel ureter |
|
E.2.2 | Secondary objectives of the trial |
Per- and post-operative complications |
Per- og postoperative komplikationer |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Indication for therapeutic semirigid ureterorenoscopy due to kidney stone. Age > 18 years
|
Indikation for terapeutisk semirigid ureteroskopi på baggrund af nyresten Alder > 18 år |
|
E.4 | Principal exclusion criteria |
Allergy to isoprenalin JJ-catheter in situ Nephrostomy in situ Known malignancies in baldder, kidney or ureter Pregnancy Lactation Disempowered In custody |
Allergi overfor isoprenalin JJ eller nefrostomi in situ kendt malign sygdom i blære, urinleder eller nyre graviditet amning umyndiggjort frihedsberøvet |
|
E.5 End points |
E.5.1 | Primary end point(s) |
If addition of isoprenalin in the irrigation fluid makes it possible to pass ureter with the ureteroscope |
Om tilsætning af isoprenalin til skyllevæsken gør det muligt at passere ureter med ureteroskop |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
during operation for kidney stone |
under operation for nyresten |
|
E.5.2 | Secondary end point(s) |
Per-and post-operative complications: infection and bleeding |
per-og postoperative komplikationer: infektion og blødning |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the operation and until patient is discharged from hospital |
under operationen og indtil udskrivelse ( 1-2 dage) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last visit of the last subject undergoing the trial |
når sidste patient er opereret og udskrevet |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |