Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367159
Status:
UNKNOWN
Last Update Posted:
2009-02-25
First Post:
2006-08-21
Brief Title:
Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
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:
Urinary tract infection UTI is a common problem in childhood associated with vesico-renal reflux VRR in 25-40 of children A persistent VRR and repeated pyelonephritis may predispose to renal scarring and chronic renal failure with an end-stage renal failure in up to 3 of childrenDefining a standard behaviour facing VRR in children is not easy because of the lack of reliable evidence Numbers of studies compare prospectively or retrospectively medical endoscopical and surgical treatmentSurgical techniques are effective but invasive and not free of complication Medical treatment is submissive to a good observance The introduction of endoscopic techniques permits to prevent UTI and new renal failure by VRR elimination Since the beginning of the endoscopic treatment several bulking agents have been proposed The ideal agent should be easy to inject stable in time and should be safe Of course it should be at least as efficient as actual bulking agent The use of Teflon was the first wave of success of endoscopic treatment But sudden passion of Teflon has been darkened by the notion of migration Since others substances have been proposed autologous or exogenous resorbable or not But none was ideal and no solutions were found facing problem of biocompatibility or long-term stabilityUsing adipose tissue as a bulking agent is ancient in plastic surgery and indications had known a leap forward in the last century with Coleman who introduced a new technique called lipostructure This technique has known a growing interest in the restoration of all volume defects in plastic surgery because of the stability of the graft We propose to apply this technique to VRR management in children in order to combine innocuousness and efficiency
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TC 197 | None | None | None |