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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Fredericia Hosptial.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323843
First Posted: May 10, 2006
Last Update Posted: January 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fredericia Hosptial
  Purpose
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.

Condition Intervention Phase
Kidney Stone Ureteroscopy Drug: Isoproterenol Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RIRS - A Method of Treating the ESWL Resistant Kidney Stone

Resource links provided by NLM:


Further study details as provided by Fredericia Hosptial:

Primary Outcome Measures:
  • Renal pelvic pressure

Secondary Outcome Measures:
  • Blood pressure
  • Pulse

Estimated Enrollment: 10
Study Start Date: June 2006
Estimated Study Completion Date: February 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323843


Locations
Denmark
Dpt. of Urology
Fredericia, Vejle Council, Denmark, 7000
Sponsors and Collaborators
Fredericia Hosptial
Investigators
Principal Investigator: Helene U Jung Fredericia Hospital, Dpt. of Urology
  More Information

ClinicalTrials.gov Identifier: NCT00323843     History of Changes
Other Study ID Numbers: 2005-005972-34
First Submitted: May 8, 2006
First Posted: May 10, 2006
Last Update Posted: January 30, 2007
Last Verified: January 2007

Keywords provided by Fredericia Hosptial:
Kidney stone
ureteropyeloscopy
renal pelvic pressure

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Isoproterenol
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Sympathomimetics
Protective Agents