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36 months follow up without change to profile. No further studies planned.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo-bladder construction | Experimental | Surgical implantation of autologous neo-bladder construct |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous neo bladder construct | Biological | augmentation cystoplasty with autologous neo-bladder construct |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders as Assessed by Compliance | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Safety Profile - Number of Participants Experiencing an Adverse Event | 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. | periodically within first 12 months as well as during long term follow up out to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunita Sheth, MD | Tengion, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Childrens Hospital | Boston | Massachusetts | 02115 | United States |
This was an open label single arm study.
11 patients were recruited between Dec 2006 and July 2007. Patients were recruited from 4 academic centers across the US. One patient withdrew from the study prior to implantation of the Neo-bladder construct and is included in the safety analysis, but not in the efficacy analysis (all implanted population).
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| ID | Title | Description |
|---|---|---|
| FG000 | Implanted Patients | Patients implanted with Tengion Neo-Bladder Augment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Study Period |
| |||||||||||||
| Long Term Follow up Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implanted Patients | Patients implanted with Tengion Neo-Bladder Augment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Responders as Assessed by Compliance | 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 | The analysis population of the primary outcome measure is the all implanted population (Intent to Treat - ITT). There was no imputation of analysis measures. | Posted | Number | participants | 12 months |
|
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Adverse events are reported for 11 subjects who were enrolled in the study. One patient withdrew prior to implantation with the neo-bladder construct and is included in the safety population but not in the all implanted population used for efficacy analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population | All patients undergoing screeing and meeting inclusion/exclusion criteria |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sunita Sheth, MD - Chief Medical Officer | Tengion, Inc. | 267-960-4805 | sunita.sheth@tengion.com |
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| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Overall Safety Profile - Number of Participants Experiencing an Adverse Event | 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. | Posted | Number | participants | periodically within first 12 months as well as during long term follow up out to 5 years |
|
|
|
| 6 |
| 11 |
| 11 |
| 11 |
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ventriculoperitoneal Shunt Malfunction | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Complication of Device Insertion | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Post Procedural Urine Leak | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Implant Site Inflammation | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Clostridial Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Enterococcal Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Molluscum Contagiosum | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Otitis Media | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Hemoglobin Decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Attention Deficit/Hyperactivity Disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
The investigator is free to individually communicate, orally present or publish in scientific journals or other scholarly media the study information at the conclusion of the study without the prior approval of the sponsor provided that 1)the results of the study in its entirely have been publically disclosed by or with the consent of the sponsor 2)18 months after the conclusion of the study at all sites whichever is first to occur.
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |