Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004487
Status:
UNKNOWN
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2001-04
Last Known Status:
ACTIVE_NOT_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:
OBJECTIVES I Determine the safety and efficacy of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux
II Determine the long term efficacy of this treatment regimen in this patient population
III Evaluate the short and long term avoidance of surgery or antibiotic therapy after this treatment regimen in this patient population
IV Estimate the riskbenefit ratio of this treatment regimen in these patients
II Determine the long term efficacy of this treatment regimen in this patient population
III Evaluate the short and long term avoidance of surgery or antibiotic therapy after this treatment regimen in this patient population
IV Estimate the riskbenefit ratio of this treatment regimen in these patients
Detailed Description:
PROTOCOL OUTLINE This is a multicenter study Patients undergo biopsy of the auricular cartilage for chondrocytes during cystoscopic evaluation on day 1 Chondrocyte alginate gel suspension is injected into the submucosa of the bladder at the vesicoureteral junction between days 40-50 Patients found to have post treatment reflux may be retreated once
Patients are followed at 1 3 and 12 months
Patients are followed at 1 3 and 12 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| REPRO-99-07 | None | None | None |
| REPRO-FDR001514 | None | None | None |