Comparing Patients After ESWL Treated With Ureteral Stent... | NCT00478998

Studies
Comparing Patients After ESWL Treated With Ureteral Stents Versus Expulsion Therapy With Tamsulosin

NCT00478998

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

May 25, 2007Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Upper Tract Ureterolithiasis

Interventions

Tamsulosin

Countries

Israel

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

May 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 24, 2007

First Submission Date that Met QC Criteria

May 24, 2007

First Posted Date

May 25, 2007Estimated

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

May 24, 2007

Last Update Posted Date

May 25, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to see whether patients undergoing ESWL, for upper tract urinary stones between 1.5-2.0cm, may be treated by expulsion therapy(Tamsulosin) instead of inserting ureteral stents .

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Tamsulosin	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients above 18 yrs of age.
Single urolithiasis up to 2 cm.
Kidney/ureters that haven't undergone previous ESWL or stent insertion.
Normal renal function (creatinine below 100mmo1/1).
Sterile urine culture.
Normal CBC, blood electrolytes and coagulation studies.
Radioopaque stones.

Exclusion Criteria:

More than one stone per kidney unit.
Patients receiving steroids, NSAIDS, calcium channel blockers or alpha blockers on a regular basis.
Anatomical anomalies or uromechanical obstruction.
Single kidney.
Cystinuria.
Soldiers or pregnant women.
Patients under 18 year

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mordechai Duvdevani, MD	Contact	0508946816		moti_duv@yahoo.com
Shilo Rosenberg, MD	Contact	0508946036		shilo_inbar@bezeqint.net

Overall Officials

Name	Affiliation	Role
Mordechai Duvdevani, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D053039	Ureterolithiasis

Ancestor Terms

ID	Term
D014515	Ureteral Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077409	Tamsulosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
stone status at 3 month .
stone free