Clinical trial · Observational
Urinary Bladder Matrix (UBM) Registry
Real-World Registry of Urinary Bladder Matrix
NCT07805798CI-TRIAL-00126043not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products. The study will evaluate patient characteristics, treatment patterns, and clinical outcomes to better understand how UBM products are used in routine clinical practice and the outcomes experienced by patients over time.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fournier's Gangrene | — | UNRESOLVED | — |
| Hidradenitis Suppurativa (HS) | Hidroacanthoma Simplex | ALIAS | 0.85 |
| Incisional | — | UNRESOLVED | — |
| Lower Extremity Wound | — | UNRESOLVED | — |
| Necrotizing Soft Tissue Infection | — | UNRESOLVED | — |
| Open Abdomen | — | UNRESOLVED | — |
| Pilonidal Cyst | — | UNRESOLVED | — |
| Pressure Ulcer (PU) | — | UNRESOLVED | — |
| Soft Tissue Reconstruction | — | UNRESOLVED | — |
| Tissue Repair | — | UNRESOLVED | — |
| Wound Management | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Urinary Bladder Matrix (UBM) Products | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective Cohort
- description
- Patients with qualifying wounds previously treated with an eligible UBM product whose clinical data are collected through abstraction of existing medical records. No study-specific interventions, procedures, or follow-up visits are required. Participants are enrolled under an IRB-approved waiver of informed consent, where applicable.
- interventionNames
- Device: Urinary Bladder Matrix (UBM) Products
- label
- Prospective Cohort
- description
- Patients receiving treatment with an eligible UBM product for a qualifying wound who provide informed consent and are followed through routine standard-of-care clinical visits. Clinical data are collected prospectively from the medical record without protocol-mandated interventions or visits.
- interventionNames
- Device: Urinary Bladder Matrix (UBM) Products
Primary outcomes (1)
- measure
- Incidence of Complete Wound Closure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria * Adults aged ≥21 years at the time of initial urinary bladder matrix (UBM) product application. * Received or are receiving an eligible UBM product for treatment of a qualifying wound, including: Pressure ulcer (Stage III/IV) Necrotizing soft tissue infection (NSTI) Fournier's gangrene Pilonidal cyst Open abdomen Hidradenitis suppurativa Acute or chronic lower extremity wound Surgical incisional wound (retrospective cohort only) * For retrospective participants, medical records must contain sufficient source documentation to support data abstraction, including wound characteristics, UBM treatment information, and post-treatment outcome data. * For prospective participants, written informed consent must be obtained prior to any registry-related data collection, and the participant must be expected to remain available for follow-up through approximately 12 months after the index UBM application. Exclusion Criteria * Wound treated with a skin substitute prior to UBM treatment. * Wound not treated with a UBM product. * Full-thickness (third-degree) burn wound. * Participation in another interventional clinical trial that, in the opinion of the investigator, may affect wound-healing outcomes. * Known terminal condition, limited life expectancy, inadequate medical records, or any other circumstance that, in the opinion of the investigator, would preclude meaningful participation in the registry or collection of adequate outcome data.
References
Publications (0)
Data not yet available
No reference posted for this study.