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 recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Interventionnelle180 participants recherchés20 sites1 pays

Enregistré dans 1 registre

ClinicalTrials.govNCT06556654Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

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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.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

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.

Methodological rigourEXPLORATORY

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

ScaleSMALL

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

Investigator standingUNKNOWN

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.

Résumé

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.

Affections

Breast Reconstruction Surgery

Éligibilité

Éligibilité
Sexe	Femme
Âges	22 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: 1. Female subjects ≥ 22 years of age. 2. First-time breast reconstruction post-mastectomy for target breast(s). 3. Scheduled to undergo unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction after mastectomy. 4. Mastectomy performed to address breast cancer or for cancer prophylaxis. 5. An informed consent form is signed by Subject or Legally Authorized Representative (LAR). 6. Subject is capable of following protocol procedures and complying with follow-up visit requirements Exclusion Criteria: Baseline Exclusion Criteria 1. Subject has had a revision(s) in the target breast(s) following complications of breast augmentation, mastopexy (breast lift), or breast reduction. 2. Subject has undergone previous radiation therapy to the reconstruction site or chest wall. 3. Subject has had chemotherapy within 3 weeks prior to the index procedure. 4. Subject has been treated for a systemic infection or local infection at the surgical site within 30 days prior to index procedure. 5. Subject has a current or previous diagnosis of Methicillin-resistant Staphylococcus aureus (MRSA). 6. Subject has a BMI \> 35. 7. Subject has a known diagnosis of diabetes with a HbA1c \> 7.0mmol/L within 30 days of the Index procedure (i.e., TE placement). 8. Subject was a current or former tobacco/nicotine user, within 90 days prior to Index Surgery (i.e., TE placement). 9. Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction. 10. Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up. 11. Subject is currently participating in or planning to participate in another investigational drug, biologic or medical device study that may interfere with compliance of TBR 22-07 study requirements or may confound TBR 22-07 study data/outcomes. 12. Subject requires a surgical technique requiring flap (autologous tissue). 13. Subject is pregnant or lactating at the time of the index procedure (i.e., TE placement) or is planning to become pregnant prior to the Exchange procedure. Intraoperative Index Procedure Exclusion 14. Based on investigator's opinion, subject has unsuitable tissue integrity for immediate 2-stage breast reconstruction or is no longer a candidate to receive the TRBR Device (will be recorded as a screen failure). 15. Subject receives an Acellular Dermal Matrix (ADM) or mesh that is not the TRBR Device in the target breast(s)

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Sans objet
Répartition	Sans objet
Modèle d'intervention	SINGLE_GROUP
Objectif principal	TREATMENT
Insu	NONE (0)
Recrutement	180 participants recherchés

Promoteur et collaborateurs

W.L.Gore & Associates Promoteur
Avania Collaborateurs

Groupes et interventions

Prospective ArmEXPERIMENTAL
Prospectively treated subjects who undergo two-stage implant-based breast reconstruction with the TRBR Device (TRBR Device group)

Interventions

Dispositif 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

Critères de jugement

Critère de jugement principal
Absence of device- or procedure-related major adverse events (MAEs)
Require rehospitalization or reoperation
Délai 1 year post index procedure
Critère de jugement secondaire
BREAST-Q Physical Well Being
Chest Score change from baseline (pre-index procedure).
Délai 1-year post-index procedure.

Dates

Dates
Date de début	9 avril 2025 (réelle)
Achèvement principal	1 juillet 2027 (estimée)
Achèvement	1 juillet 2030 (estimée)
Première publication	16 août 2024 (réelle)
Dernière mise à jour	23 octobre 2025
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	octobre 2025

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

16 sites sont en recrutement

United States

United States
Établissement	Ville	État ou région	Statut
The Johns Hopkins University	Baltimore	Maryland	En recrutement
The Cleveland Clinic Foundation	Cleveland	Ohio	Pas encore en recrutement
Northwestern University	Evanston	Illinois	En recrutement
Endeavor Health (Northshore University HealthSystem Research Institute)	Evanston	Illinois	En recrutement
Corewell Health Research Institute	Grand Rapids	Michigan	En recrutement
The Regents of the University of California	Irvine	California	Pas encore en recrutement
University of Mississippi	Jackson	Mississippi	En recrutement
Mayo Clinic Florida	Jacksonville	Florida	En recrutement
Cedars-Sinai Plastic and Reconstruction Surgery	Los Angeles	California	Pas encore en recrutement
The Board of Regents of the University of Wisconsin System	Madison	Wisconsin	En recrutement
The Medical College of Wisconsin, Inc.	Milwaukee	Wisconsin	Pas encore en recrutement
Riverside University Health System-Medical Center	Moreno Valley	California	En recrutement
The Joan and Sanford I. Weill Medical College of Cornell University	New York	New York	En recrutement
The Board of Regents of the University of Nebraska	Omaha	Nebraska	En recrutement
The Fox Chase Cancer Center	Philadelphia	Pennsylvania	En recrutement
University of Pennsylvania	Philadelphia	Pennsylvania	En recrutement
Mayo Clinic Arizona	Scottsdale	Arizona	En recrutement
The University of Washington Medical Center	Seattle	Washington	En recrutement
University of Arizona	Tucson	Arizona	En recrutement
BR Hope LLC	Wichita	Kansas	En recrutement

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06556654