Kidney StonePhase 2NCT00323843
Retrograde Intrarenal Stone Surgery - A Method of Treating the ESWL Resistant Kidney Stone
A Phase 2 study testing Isoproterenol in people with Kidney Stone and Ureteroscopy, run by Fredericia Hosptial at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Ureteroscopy
- What is being tested?
- Isoproterenol
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2006to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for RIRS procedure
- Age > 18 years
- Normotensive
- Capable of understanding information given
Who cannot join
- 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
Show all 12Show fewer
- Bladder disease
- Nephrostomies inserted
- JJ-catheters inserted
- Prisoners
- Pregnant
- Nursing mothers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Kidney Stone, Ureteroscopy
- Being tested
- Isoproterenol
- Keywords
- Kidney stone, ureteropyeloscopy, renal pelvic pressure
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoproterenolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal pelvic pressure
Secondary outcomes (2)
Blood pressure
Pulse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2006 (estimated)
- Study startJun 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Fredericia Hosptial
- Sponsor type
- University, hospital or other
- Investigators
- Helene U Jung, Principal investigator, Fredericia Hospital, Dpt. of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323843
- Sponsor's protocol ID
- 2005-005972-34
- Other IDs
- 2005
- Status last verified
- Jan 2007
- First submitted
- 8 May 2006
- Last updated
- 30 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIRS - A Method of Treating the ESWL Resistant Kidney Stone
- ClinicalTrials.gov ID
- NCT00323843
- Acronym / sponsor ID
- 2005-005972-34
- Conditions
- Kidney Stone, Ureteroscopy
- Keywords
- Kidney stone, ureteropyeloscopy, renal pelvic pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- Fredericia HosptialUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Feb 2007
- First posted
- 10 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indication for RIRS procedure
- Age > 18 years
- Normotensive
- Capable of understanding information given
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoproterenol | Drug | – |
Primary outcome
Renal pelvic pressure
2 secondary outcomes
Blood pressure
Pulse
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene U Jung principal investigator
Fredericia Hospital, Dpt. of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isoproterenol in people with Kidney Stone and Ureteroscopy, run by Fredericia Hosptial at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal pelvic pressure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2007.