Retrograde Intrarenal Stone Surgery - A Method of Treatin... | NCT00323843

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

NCT00323843

Sponsor

Fredericia Hosptial

Status

Unknown status

Last Update Posted

Jan 30, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Kidney Stone
Ureteroscopy

Interventions

Isoproterenol

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Feb 2007

First Submitted Date

May 8, 2006

First Submission Date that Met QC Criteria

May 8, 2006

First Posted Date

May 10, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2007

Last Update Posted Date

Jan 30, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Isoproterenol	Drug

Measure	Description	Time Frame
Renal pelvic pressure

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helene U Jung	Fredericia Hospital, Dpt. of Urology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dpt. of Urology		Fredericia	Vejle Council	7000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007545	Isoproterenol

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided