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

January 29, 2007 updated by: Fredericia Hosptial

RIRS - A Method of Treating the ESWL Resistant Kidney Stone

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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Vejle Council
      • Fredericia, Vejle Council, Denmark, 7000
        • Dpt. of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Renal pelvic pressure

Secondary Outcome Measures

Outcome Measure
Blood pressure
Pulse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helene U Jung, Fredericia Hospital, Dpt. of Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion

February 1, 2007

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 10, 2006

Study Record Updates

Last Update Posted (Estimate)

January 30, 2007

Last Update Submitted That Met QC Criteria

January 29, 2007

Last Verified

January 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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