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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

Diese Studie kontaktieren

Kurz gefasst

Interventionell180 Teilnehmende gesucht20 Studienzentren1 Land

In 1 Register registriert

ClinicalTrials.govNCT06556654Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

Eine Studie kann in mehreren Registern registriert sein. Wir zeigen sie einmal und verlinken jeden Eintrag, den wir haben.

Die Studieninformationen werden so angezeigt, wie sie vom Register veröffentlicht wurden, in ihrer Originalsprache.

Interesse an dieser Studie?

Anmelden oder ein Konto erstellen um Ihr Interesse zu bekunden und diese Studie zu verfolgen.

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.

Zusammenfassung

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.

Erkrankungen

Breast Reconstruction Surgery

Eignung

Eignung
Geschlecht	Weiblich
Alter	22 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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)

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Nicht zutreffend
Zuteilung	Nicht zutreffend
Interventionsmodell	SINGLE_GROUP
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	180 Teilnehmende gesucht

Sponsor und Mitwirkende

W.L.Gore & Associates Sponsor
Avania Mitwirkende

Studienarme und Interventionen

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

Interventionen

Medizinprodukt 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

Endpunkte

Primärer Endpunkt
Absence of device- or procedure-related major adverse events (MAEs)
Require rehospitalization or reoperation
Zeitrahmen 1 year post index procedure
Sekundärer Endpunkt
BREAST-Q Physical Well Being
Chest Score change from baseline (pre-index procedure).
Zeitrahmen 1-year post-index procedure.

Daten

Daten
Startdatum	9. April 2025 (tatsächlich)
Primärer Abschluss	1. Juli 2027 (geschätzt)
Abschluss	1. Juli 2030 (geschätzt)
Erstveröffentlichung	16. August 2024 (tatsächlich)
Zuletzt aktualisiert	23. Oktober 2025
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Oktober 2025

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

16 Studienzentren rekrutieren

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
The Johns Hopkins University	Baltimore	Maryland	Rekrutiert
The Cleveland Clinic Foundation	Cleveland	Ohio	Rekrutierung noch nicht begonnen
Northwestern University	Evanston	Illinois	Rekrutiert
Endeavor Health (Northshore University HealthSystem Research Institute)	Evanston	Illinois	Rekrutiert
Corewell Health Research Institute	Grand Rapids	Michigan	Rekrutiert
The Regents of the University of California	Irvine	California	Rekrutierung noch nicht begonnen
University of Mississippi	Jackson	Mississippi	Rekrutiert
Mayo Clinic Florida	Jacksonville	Florida	Rekrutiert
Cedars-Sinai Plastic and Reconstruction Surgery	Los Angeles	California	Rekrutierung noch nicht begonnen
The Board of Regents of the University of Wisconsin System	Madison	Wisconsin	Rekrutiert
The Medical College of Wisconsin, Inc.	Milwaukee	Wisconsin	Rekrutierung noch nicht begonnen
Riverside University Health System-Medical Center	Moreno Valley	California	Rekrutiert
The Joan and Sanford I. Weill Medical College of Cornell University	New York	New York	Rekrutiert
The Board of Regents of the University of Nebraska	Omaha	Nebraska	Rekrutiert
The Fox Chase Cancer Center	Philadelphia	Pennsylvania	Rekrutiert
University of Pennsylvania	Philadelphia	Pennsylvania	Rekrutiert
Mayo Clinic Arizona	Scottsdale	Arizona	Rekrutiert
The University of Washington Medical Center	Seattle	Washington	Rekrutiert
University of Arizona	Tucson	Arizona	Rekrutiert
BR Hope LLC	Wichita	Kansas	Rekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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