- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00323843
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
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
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Vejle Council
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Fredericia, Vejle Council, Denmark, 7000
- Dpt. of Urology
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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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Pathological Conditions, Anatomical
- Urolithiasis
- Urinary Calculi
- Calculi
- Kidney Calculi
- Nephrolithiasis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic Agonists
- Cardiotonic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Isoproterenol
Other Study ID Numbers
- 2005-005972-34
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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