Shockwave Lithotripsy (SWL) Under Selective, General Anes... | NCT01008267

Studies
Shockwave Lithotripsy (SWL) Under Selective, General Anesthesia.

NCT01008267

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Nov 5, 2009Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Renal Calculi
Ureteral Calculi

Interventions

Not provided

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

Mar 2009

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

Nov 2009

Primary Completion Date

Oct 2010Estimated

Completion Date

Not provided

First Submitted Date

Nov 4, 2009

First Submission Date that Met QC Criteria

Nov 4, 2009

First Posted Date

Nov 5, 2009Estimated

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

Nov 4, 2009

Last Update Posted Date

Nov 5, 2009Estimated

Description Module

Brief Summary

SWL is widely used in the treatment of patients with renal and ureteral calculi. Several factors determine the success of extracorporeal shockwave lithotripsy (SWL) for kidney stones: stone size, stone location within the collecting system, stone type, and the SWL machine used. Moreover, in some cases it is very difficult to focus on the stone because of its movement as a results of breathing. In order to prevent stone movement we want to use a bronchial blocker, processing a selective ventilation of the opposite side of stone location.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SWL under general anesthesia		Patients who failed in SWL under sedation(a standard protocol), will undergo a second SWL process under general anesthesia.
SWL under general selective anesthesia		Patients who failed in SWL under sedation(a standard protocol), will undergo a second SWL process under general selective anesthesia, using a bronchial blocker.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 years old
Not pregnant
All patients who failed in SWL process, taken under sedation (standard protocol)

Exclusion Criteria:

Age < 18
Pregnancy

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

Patients who failed in SWL process taken under sedation (standard protocol)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthesiology department, Assaf-Harofeh MC		Beer-Yaakov, Zrifin		70300	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D014514	Ureteral 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