Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419120
Status:
TERMINATED
Last Update Posted:
2015-11-30
First Post:
2007-01-04
Brief Title:
Augmentation Cystoplasty Using an Autologous Neo-Bladder
Sponsor:
Tengion
Organization:
Tengion
Study Overview
Official Title:
An Open-Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Spina Bifida
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
36 months follow up without change to profile No further studies planned
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment will be enrolled The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance
Detailed Description:
Subjects with neurogenic bladder secondary to spina bifida myelodysplasia that is refractory to medical treatment and require augmentation cystoplasty will be enrolled The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase bladder compliance
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