Clinical Evaluation of a Novel Textile Radiation Protection Device
12. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Michael Kassin, MD
- Telefonnummer: 770-712-6913
- E-post: michael.t.kassin@emory.edu
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30322
- Emory University Hospital
-
Ta kontakt med:
- Michael U Kassin, MD
- Telefonnummer: 770-712-6913
- E-post: michael.t.kassin@emory.edu
-
Atlanta, Georgia, Forente stater, 30308
- Emory University Hospital Midtown
-
Ta kontakt med:
- Michael UH Kassin, MD
- Telefonnummer: 770-712-6913
- E-post: michael.t.kassin@emory.edu
-
Ta kontakt med:
- Emory UH Midtown
-
Atlanta, Georgia, Forente stater, 30308
- Winship Cancer Institute
-
Ta kontakt med:
- Michael UH Kassin, MD
- Telefonnummer: 770-712-6913
- E-post: michael.t.kassin@emory.edu
-
Ta kontakt med:
- Emory UH Midtown
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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. 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. |
|
Eksperimentell: 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.
|
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. 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Radiation dose comparing standard PPE vs. Texray PPE groups
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Role-specific radiation dose
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Zachary Bercu, MD, Emory University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. juli 2027
Datoer for studieregistrering
Først innsendt
12. august 2026
Først innsendt som oppfylte QC-kriteriene
12. august 2026
Først lagt ut (Faktiske)
17. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2025P011985
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified radiation safety data by participant will be shared.
IPD-delingstidsramme
3 month post publication to 5 years post publication
Tilgangskriterier for IPD-deling
Principal research investigators for radiation safety related analyses by direct email request.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
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