NCT06556654ClinicalTrials.gov
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast Reconstruction
En resumen
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Treatment Arm, where data will be collected for a new medical device called…
De intervención180 participantes buscados20 centros1 país
Registrado en 1 registro
- ClinicalTrials.govNCT06556654Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses
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How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2024-08-16; recorded start 2025-04-09
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
- Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 41 other studies in this databaseCounted from the lead sponsor named in the record (W.L.Gore & Associates)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 1 condition.
- Lead sponsor type recorded as: industry.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation0/20
Allocation not stated in the record
- Blinding0/20
Open-label
- Control arm0/15
No comparator arm stated in the record
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
- Multi-centre8/8
Multi-centre: 20 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A small study: 180 participants (target), run at 20 sites.
How this score is built
- Enrolment21/40
180 participants (target)
- Site count15/25
20 sites
- Country count0/15
Single country
- Planned duration10/10
Planned over about 64 months
- Sponsor scale6/10
W.L.Gore & Associates has led 41 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
Resumen
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Treatment Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Control Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Control Arm.
Afecciones
- Breast Reconstruction Surgery
Elegibilidad
| Sexo | Mujer |
|---|---|
| Edades | 22 Years – Sin máximo |
| Voluntarios sanos | No |
Elegibilidad tal como figura en el registro
Elegibilidad en frases sencillas
Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.
Diseño del estudio
| Tipo de estudio | De intervención |
|---|---|
| Fase | No aplicable |
| Asignación | No aplicable |
| Modelo de intervención | SINGLE_GROUP |
| Propósito principal | TREATMENT |
| Enmascaramiento | NONE (0) |
| Inscripción | 180 participantes buscados |
Patrocinador y colaboradores
- W.L.Gore & Associates Patrocinador
- Avania Colaboradores
Grupos e intervenciones
- Prospective ArmEXPERIMENTAL
Prospectively treated subjects who undergo two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group)
Intervenciones
- Dispositivo TRBR Device
The GORE® Tissue Reinforcement for Breast Reconstruction device is intended to reinforce the soft tissue surrounding the tissue expander in preparation for the breast implant in post-mastectomy breast reconstruction
Variables de resultado
Variable de resultado principal
Absence of device- or procedure-related major adverse events (MAEs)
Require rehospitalization or reoperation
Plazo 1 year post index procedure
Variable de resultado secundaria
BREAST-Q Physical Well Being
Chest Score change from baseline (pre-index procedure).
Plazo 1-year post-index procedure.
Fechas
| Fecha de inicio | 9 de abril de 2025 (real) |
|---|---|
| Finalización principal | 1 de julio de 2027 (estimada) |
| Finalización | 1 de julio de 2030 (estimada) |
| Primera publicación | 16 de agosto de 2024 (real) |
| Última actualización | 23 de octubre de 2025 |
| Resultados publicados | No indicado en el registro |
| Estado verificado por última vez | octubre de 2025 |
Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.
Ubicaciones
16 centros están en reclutamiento
United States
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| The Johns Hopkins University | Baltimore | Maryland | En reclutamiento |
| The Cleveland Clinic Foundation | Cleveland | Ohio | Aún no recluta |
| Northwestern University | Evanston | Illinois | En reclutamiento |
| Endeavor Health (Northshore University HealthSystem Research Institute) | Evanston | Illinois | En reclutamiento |
| Corewell Health Research Institute | Grand Rapids | Michigan | En reclutamiento |
| The Regents of the University of California | Irvine | California | Aún no recluta |
| University of Mississippi | Jackson | Mississippi | En reclutamiento |
| Mayo Clinic Florida | Jacksonville | Florida | En reclutamiento |
| Cedars-Sinai Plastic and Reconstruction Surgery | Los Angeles | California | Aún no recluta |
| The Board of Regents of the University of Wisconsin System | Madison | Wisconsin | En reclutamiento |
| The Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | Aún no recluta |
| Riverside University Health System-Medical Center | Moreno Valley | California | En reclutamiento |
| The Joan and Sanford I. Weill Medical College of Cornell University | New York | New York | En reclutamiento |
| The Board of Regents of the University of Nebraska | Omaha | Nebraska | En reclutamiento |
| The Fox Chase Cancer Center | Philadelphia | Pennsylvania | En reclutamiento |
| University of Pennsylvania | Philadelphia | Pennsylvania | En reclutamiento |
| Mayo Clinic Arizona | Scottsdale | Arizona | En reclutamiento |
| The University of Washington Medical Center | Seattle | Washington | En reclutamiento |
| University of Arizona | Tucson | Arizona | En reclutamiento |
| BR Hope LLC | Wichita | Kansas | En reclutamiento |
Documentos del estudio
No hay documentos enlazados en este registro.
Cambios a lo largo del tiempo
No se han registrado cambios desde que incorporamos este registro por primera vez.
Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.