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NCT00323843 Clinical Trial

Retrograde Intrarenal Stone Surgery - A Method of Treating the ESWL Resistant Kidney Stone

Kidney Stone Clinical Trial

Official title:
RIRS - A Method of Treating the ESWL Resistant Kidney Stone

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00323843
Other study ID # 2005-005972-34
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received May 8, 2006
Last updated January 29, 2007
Start date June 2006
Est. completion date February 2007

Study information
Verified date January 2007
Source Fredericia Hosptial
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

Is it possible to decrease the intrarenal pressure in the kidney during endoscopic management of kidney stone by topical administration of drugs? In order to secure fewer complications in ureteroscopic operations the pharmacological agent isoproterenol is tested on pigs and human to determine its potential of lowering intrarenal pressure.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 10
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Indication for RIRS procedure

- Age > 18 years

- Normotensive

- Capable of understanding information given

Exclusion Criteria:

- Previous myocardiac infarct

- Daily use of alpha- og beta- blocking medicine og calcium antagonists

- Use of NSAID the last 2 days

- Stone in the ureter

- Declared

- Known malignant disease in urinary tract

- Bladder disease

- Nephrostomies inserted

- JJ-catheters inserted

- Prisoners

- Pregnant

- Nursing mothers

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Isoproterenol

Locations
Country Name City State
Denmark Dpt. of Urology Fredericia Vejle Council

Sponsors (1)
Lead Sponsor Collaborator
Fredericia Hosptial

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Renal pelvic pressure
Secondary Blood pressure
Secondary Pulse
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