E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Resistance in the ureter when inserting a ureteral access sheath during ureterorenoscopy. |
Modstand i ureter ved anlæggelse af ureteral access sheath under ureterorenoskopi. |
|
E.1.1.1 | Medical condition in easily understood language |
Resistance in the ureter when inserting a ureteral access sheath during endoscopy of the kidney. |
Modstand i urinlederen ved anlæggelse af ureteral access sheath under kikkertundersøgelser i nyren. |
|
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 | 16.1 |
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 isoprenaline to the irrigation fluid makes it possible to insert an access sheath in the ureter of patients were insertion was impossible because of ureteral resistance. |
At undersøge om tilsætning af isoprenalin til skyllevæsken gør det muligt at anlægge access sheath i ureter på patienter hvor det ellers ikke var muligt på grund af modstand i ureter. |
|
E.2.2 | Secondary objectives of the trial |
Assessment of peroperative lesions in the ureter.
Assessment of postoperative complications. |
Vurdering af evt peroperative læsioner i ureter.
Vurdering af evt postoperative komplikationer. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Indication for diagnostic og therapeutic flexible ureterorenoscopy, and expected use of access sheath.
Age > 18 years. |
Indikation for diagnostisk eller terapeutisk ureterorenoskopi hvor det forventes at man vil anvende UAS.
Alder >18 år. |
|
E.4 | Principal exclusion criteria |
Allergy to isoprenalin
JJ-catheter in situ
Nephrostomy in situ
Ipsilateral ureteral stone
Known malignancies in bladder, ureter or kidney
Pregnancy
Lactation
Disempowered
In custody |
Allergi overfor isoprenalin
JJ-kateter in situ
Nefrostomi in situ
Ipsilateral uretersten
Kendt malignitet i blære, ureter eller nyre
Graviditet
Amning
Umyndiggjort
Frihedsberøvet |
|
E.5 End points |
E.5.1 | Primary end point(s) |
If addition of isoprenaline to the irrigation fluid makes it possible to fully insert a ureteral access sheath to the kidney in patients where this was not possible because of ureteral resistance. |
Om tilsætning af isoprenalin til skyllevæsken gør det muligt fuldt at anlægge ureteral access sheath til nyren på patienter hvor dette ikke var muligt på grund af ureteral modstand. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 1 minute of irrigation, insertion of ureteral access sheath wil be attempted. If it is not possible irrigation is repeated for 1 minute before another attempt of insertion. This is repeated max. 5 times, where after the intervention is over.
If insertion is successfull the intervention is over as well. |
Efter 1 minuts skylning, gøres et nyt anlæggelses forsøg med ureteral access sheath. Hvis det ikke lykkes skylles igen 1 minut før nyt anlæggelsesforsøg. Dette gentages max. 5 gange, hvorefter interventionen er slut.
Interventionen er også slut hvis anlæggelse lykkes. |
|
E.5.2 | Secondary end point(s) |
Assessment of peroperative lesions in the ureter.
Assessment of postoperative complications, infection or bleeding. |
Vurdering af evt peroperative læsioner i ureter.
Vurdering af evt postoperative komplikationer, infektion eller blødning. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the operation and until discharge from the hospital. |
Under operationen og indtil udskrivelse fra sygehuset. |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |