Augmentation Cystoplasty Using an Autologous Neo-Bladder
This study has been terminated.
(36 months of longterm follow up have been completed without substantial change to the profile. No further studies are currently planned.)
Sponsor:
Tengion
Information provided by:
Tengion
ClinicalTrials.gov Identifier:
NCT00419120
First received: January 4, 2007
Last updated: August 9, 2011
Last verified: August 2011
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| Tracking Information | |||||
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| First Received Date ICMJE | January 4, 2007 | ||||
| Last Updated Date | August 9, 2011 | ||||
| Start Date ICMJE | December 2006 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of Responders as Assessed by Compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ] Efficacy of the autologous neo-bladder construct as assessed by a responder analysis (comparing each patient's baseline with 12 month data). Improvement in compliance (i.e. improved bladder pressure/volume relationship) was measured by urodynamics at predetermined bladder pressure points. This was coupled with an assessment of clinical benefit and used to determine responders versus non-responders |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00419120 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Overall Safety Profile - Number of Participants Experiencing an Adverse Event [ Time Frame: periodically within first 12 months as well as during long term follow up out to 5 years ] [ Designated as safety issue: Yes ] clinical evaluation of adverse events, laboratory parameters and urinary imaging to assess any safety issues emerging from this technology and to allow a comparison of a safety profile with standard of care enterocystoplasty. Please refer to the Adverse Event section for detailed information. |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Augmentation Cystoplasty Using an Autologous Neo-Bladder | ||||
| Official Title ICMJE | An Open-Label Multicenter Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Spina Bifida | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Neurogenic Bladder | ||||
| Intervention ICMJE | Other: Autologous neo bladder construct
augmentation cystoplasty with autologous neo-bladder construct |
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| Study Arm (s) | Experimental: 1
Receipt of autologous neo-bladder construct
Intervention: Other: Autologous neo bladder construct |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00419120 | ||||
| Other Study ID Numbers ICMJE | TNG-CL003 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Sunita Sheth, MD, Tengion, Inc | ||||
| Study Sponsor ICMJE | Tengion | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tengion | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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