NCT00959153

Brief Summary

A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects will be followed for 14 days. If at the 14 day follow-up visit the subject continues to present with a stone size 4 mm or greater will have an option of retreatment or other intervention. If the subject consents to be retreated at this time, this subject will be followed up for another 14 days.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

Enrollment Period

1.2 years

First QC Date

August 11, 2009

Last Update Submit

May 31, 2011

Conditions

Kidney Stones

Keywords

Fragmenting of kidney stonesextracorporeal shockwave lithotripsy

Outcome Measures

Primary Outcomes (1)

  • stone fragmentation

    14 days

Study Arms (1)

Kidney stones

EXPERIMENTAL

Kidney stones

Device: LithoSpace Extracorporeal Shockwave Lithotripter

Interventions

LithoSpace Extracorporeal Shockwave LithotripterDEVICE

Shockwave therapy to break up kidney stones

Kidney stones

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of a solitary Urinary stones in the renal pelvis or renal calyces or ureter
  • Presence of one stone greater than 4 mm and less than 12 mm

You may not qualify if:

  • Urinary tract obstruction, acute or unresolved cholecystitis, cholangitis, pancreatitis or obstruction of the biliary duct system
  • Impaction of stone to be treated
  • Staghorn stones
  • Failed or inadequate lithotripsy procedure within 3 months prior to study
  • Coagulation abnormalities or anticoagulation therapy
  • Pregnant or females of child-bearing potential General, spinal or epidural anesthesia is contraindicated
  • Can not be positioned correctly for fluoroscopic imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Metropolitan Lithotriptor Associates

Garden City, New York, 11530, United States

Location

Allied Urological Services, LLC

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 14, 2009

Study Start

June 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

US(2)