NCT01008267

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Last Updated

November 5, 2009

Status Verified

March 1, 2009

Enrollment Period

11 months

First QC Date

November 4, 2009

Last Update Submit

November 4, 2009

Conditions

Renal CalculiUreteral Calculi

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Age \< 18
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology department, Assaf-Harofeh MC

Beer-Yaakov, Zrifin, 70300, Israel

Location

MeSH Terms

Conditions

Kidney CalculiUreteral Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUreterolithiasisUreteral Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 5, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2010

Last Updated

November 5, 2009

Record last verified: 2009-03

Locations

IL(1)