Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT01807260
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2013-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stepwise Shock Wave Lithotripsy in Pediatric Urolithiasis
Sponsor:
TC Erciyes University
Organization:
Study Overview
Official Title:
STEPWISE SHOCK WAVE LITHOTRIPSY IN PEDIATRIC UROLITHIASIS: A COMPARATIVE STUDY.
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis.
Detailed Description:
Between March 2008 and February 2012, 81 patients were randomized and included in this study. Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument. Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group. In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000. Patients were followed up with 15 days interval. In each visit, patients were respectively questioned for pain, hematuria and history of stone passage. In case of treatment failure, shock wave lithotripsy was repeated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: