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

Primary Purpose

Kidney Stone, Ureteroscopy

Status

Unknown status

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Isoproterenol

About this trial

This is an interventional treatment trial for Kidney Stone focused on measuring Kidney stone, ureteropyeloscopy, renal pelvic pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dpt. of Urology

Outcomes

Primary Outcome Measures

Renal pelvic pressure

Secondary Outcome Measures

Blood pressure

Pulse

Full Information

NCT ID

NCT00323843

First Posted

May 8, 2006

Last Updated

January 29, 2007

Sponsor

Fredericia Hosptial

1. Study Identification

Unique Protocol Identification Number

NCT00323843

Brief Title

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

Official Title

RIRS - A Method of Treating the ESWL Resistant Kidney Stone

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

June 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Fredericia Hosptial

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Stone, Ureteroscopy

Keywords

Kidney stone, ureteropyeloscopy, renal pelvic pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Isoproterenol

Primary Outcome Measure Information:

Title

Renal pelvic pressure

Secondary Outcome Measure Information:

Title

Blood pressure

Title

Pulse

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helene U Jung

Organizational Affiliation

Fredericia Hospital, Dpt. of Urology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dpt. of Urology

City

Fredericia

State/Province

Vejle Council

ZIP/Postal Code

7000

Country

Denmark

12. IPD Sharing Statement

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

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