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Clinical Evaluation of a Novel Textile Radiation Protection Device

12. August 2026 aktualisiert von: Zachary Bercu, Emory University

Evaluation of Novel Woven Fabric Radiation Protection Gear for Head and Neck Regions for Interventional Radiology Personnel

This study will use procedure-specific dosimetry to evaluate whether Texray's novel woven radiation protection fabric (HeadPeace and MindPeace) reduces occupational radiation dose to the head and thyroid of interventional radiology personnel compared with standard radiation protection equipment, and to explore variation in efficacy by role, procedure type, and fluoroscopy room/equipment characteristics.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Emory Interventional Radiology (IR) would like to conduct the first real-world United States study of a novel radiation protection device during IR procedures. The device is approved for use in the United States. It involves a headpiece and a neckpiece in addition to the user's standard protective gear. The equipment was developed by a start-up with headquarters in the US and Sweden and involves a novel textile fabric that reduces radiation exposure from scatter specifically to the face, eyes, and brain for the user. The device itself is not known to increase radiation dose to anyone in the room (it is not known to increase reflective radiation to patient or anyone in proximity of wearer). Study enrollment/target will be 20 people. This study is not targeting enrollment of vulnerable populations including minors, prisoners, pregnant persons, neonates or human fetuses, wards of the state, or cognitively impaired. Informed consent will be provided using an IRB-approved consent form and stored confidentially using IRB-standard processes. The study will be discussed with thorough instructions regarding use of the equipment. Subjects will be permitted to withdraw at any time. The investigators intend to provide 10 pieces of equipment to healthcare workers in a number of roles (physician, technologists, nurses, and anesthetists) who work in interventional radiology. The research team will then compare their monthly dosimetry data to their standard data over the same time period either immediately before or after the period of use of the novel equipment. Each phase will take place over a 4-week period (4 weeks wearing the new equipment and 4 weeks wearing the standard equipment). No other changes will be made to procedures, in-room technology, other radiation protective equipment. The study will be conducted at Emory University Hospital, Emory University Hospital Midtown, and Winship Emory Midtown. Radiation badge/dosimetry data will be collected utilizing the standard approach (monthly monitoring) under the standard teams supervised by the Radiation Safety Officer (RSO). Dosimetry data will be provided to the Emory investigators for analysis. Dosimetry data will be stored only as per standard protocol for radiation workers. No additional data or specimens will be stored other than what is required per standard protocol for radiation workers. The procedures performed over the study period, rooms procedures performed in, dates of procedures, length of each procedure, radiation metrics for each period, and role of the radiation device wearer will be collected and aggregated. User information will only be available to the investigator performing aggregate collection and then will be anonymized before analysis. Analysis will focus on differences in radiation dose exposure with and without use of the equipment. Post-hoc analysis will assess if there is a suggestion radiation reduction is greater with certain factors, such as: role of device wearer, specific room used (recognizing that older rooms tend to have higher radiation doses and scatter), types of procedures performed, average lengths of procedures and other radiation metrics of procedures.

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30322
      • Atlanta, Georgia, Vereinigte Staaten, 30308
        • Emory University Hospital Midtown
        • Kontakt:
        • Kontakt:
          • Emory UH Midtown
      • Atlanta, Georgia, Vereinigte Staaten, 30308
        • Winship Cancer Institute
        • Kontakt:
        • Kontakt:
          • Emory UH Midtown

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Age ≥18 years.
  • Employed or regularly working in the IR department at the study site.
  • Routinely present in fluoroscopy-guided procedures (e.g., IR attending, IR trainee, technologist, IR nurse, anesthesia provider).
  • Scheduled to work in procedure rooms equipped with Texray garments and dosimetry systems during the study period.
  • Willing and able to provide informed consent.
  • Willing to wear Texray PPE and/or standard PPE with dosimeters as specified by the study protocol.

Exclusion Criteria:

  • Age <18 years.
  • Not regularly present in IR suites during fluoroscopy-based procedures.
  • Known pregnancy at the time of enrollment.
  • Presence of a musculoskeletal or dermatologic condition that, in the opinion of the investigator or the participant, would prevent safe use of the Texray garments (e.g., inability to tolerate additional weight or fabric contact).
  • Decline to participate or are unable to provide informed consent.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Group A: Standard Personal Protective Equipment (PPE) only then Texray PPE
Participants in Group A will wear their usual radiation personal protection equipment (PPE) during procedures for the first 4 weeks. After completing a brief orientation and fitting session for the Texray personal protective equipment (PPE), they will wear the HeadPeace (non-lead head protector) and MindPeace (non-lead thyroid and face protector) during procedures for the following 4 weeks.
Gerät: Standard PPE

Standard PPE (Baseline Phase):

Participants wear their usual radiation protection equipment, including standard lead aprons and thyroid collars (and any head coverings they already use). Personal dosimeters are placed at predefined anatomical regions mimicking Texray coverage (e.g., forehead, temples, anterior/lateral thyroid) over standard PPE. These readings provide baseline scatter radiation exposure under current clinical conditions.

Gerät: Texray PPE

Texray PPE (Intervention Phase):

During the intervention phase, participants wear HeadPeace (non-lead head protector) and MindPeace (non-lead thyroid and face protector) during procedures. Each garment includes internal and external dosimeter pockets at key anatomical sites to enable paired measurements beneath and outside the shield. These data support calculation of percent dose reduction and attenuation at specific sites.
Experimental: Texray PPE then Standard PPE only
Participants in Group B will complete a brief orientation and fitting session for the Texray personal protective equipment (PPE) and will wear the HeadPeace (non-lead head protector) and MindPeace (non-lead thyroid and face protector) during procedures for the first 4 weeks. They will then switch to wearing their usual radiation PPE during procedures for the following 4 weeks.
Gerät: Standard PPE

Standard PPE (Baseline Phase):

Participants wear their usual radiation protection equipment, including standard lead aprons and thyroid collars (and any head coverings they already use). Personal dosimeters are placed at predefined anatomical regions mimicking Texray coverage (e.g., forehead, temples, anterior/lateral thyroid) over standard PPE. These readings provide baseline scatter radiation exposure under current clinical conditions.

Gerät: Texray PPE

Texray PPE (Intervention Phase):

During the intervention phase, participants wear HeadPeace (non-lead head protector) and MindPeace (non-lead thyroid and face protector) during procedures. Each garment includes internal and external dosimeter pockets at key anatomical sites to enable paired measurements beneath and outside the shield. These data support calculation of percent dose reduction and attenuation at specific sites.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Radiation dose comparing standard PPE vs. Texray PPE groups
Zeitfenster: Baseline, 4 and 8 weeks post-intervention
Radiation dose to the head and thyroid region (mSv), as measured by personal dosimeters during fluoroscopy-guided procedures, comparing standard PPE vs. Texray PPE groups.
Baseline, 4 and 8 weeks post-intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Role-specific radiation dose
Zeitfenster: Baseline, 4 and 8 weeks post-intervention
Role-specific radiation dose in mSv will be measured (attending IR, trainee, technologist, nurse, anesthesia) comparing standard PPE vs. Texray PPE groups.
Baseline, 4 and 8 weeks post-intervention
Procedure-specific radiation dose
Zeitfenster: Baseline, 4 and 8 weeks post-intervention
Procedure-specific radiation dose in mSv (e.g., liver-directed therapy, embolization, venography, line and port placement) will be measured comparing standard PPE vs. Texray PPE groups.
Baseline, 4 and 8 weeks post-intervention
Radiation dose and attenuation stratified by fluoroscopy room
Zeitfenster: Baseline, 4 and 8 weeks post-intervention
Radiation dose will be measured comparing standard PPE vs. Texray PPE groups stratified by fluoroscopy room and equipment age (new vs. legacy systems).
Baseline, 4 and 8 weeks post-intervention
Number of participants with correct donning/doffing placement of the PPE
Zeitfenster: Baseline, 4 and 8 weeks post-intervention
Number of participants with correct PPE donning/doffing will be recorded.
Baseline, 4 and 8 weeks post-intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Emory University

Ermittler

  • Hauptermittler: Zachary Bercu, MD, Emory University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. Juli 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

12. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. August 2026

Zuerst gepostet (Tatsächlich)

17. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 2025P011985

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified radiation safety data by participant will be shared.

IPD-Sharing-Zeitrahmen

3 month post publication to 5 years post publication

IPD-Sharing-Zugriffskriterien

Principal research investigators for radiation safety related analyses by direct email request.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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