Clinical Evaluation of a Novel Textile Radiation Protection Device

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Radiation Exposure
• Intervention / Treatment: Device: Standard PPE; Device: Texray PPE

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Kassin, MD; Phone Number: 770-712-6913; Email: michael.t.kassin@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
      • Contact: Michael U Kassin, MD; Phone Number: 770-712-6913; Email: michael.t.kassin@emory.edu
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
      • Contact: Michael UH Kassin, MD; Phone Number: 770-712-6913; Email: michael.t.kassin@emory.edu
      • Contact: Emory UH Midtown
    • Atlanta, Georgia, United States, 30308
      • Winship Cancer Institute
      • Contact: Michael UH Kassin, MD; Phone Number: 770-712-6913; Email: michael.t.kassin@emory.edu
      • Contact: Emory UH Midtown

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.; Device: 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.	Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation dose comparing standard PPE vs. Texray PPE groups	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Role-specific radiation dose	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	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	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	Number of participants with correct PPE donning/doffing will be recorded.	Baseline, 4 and 8 weeks post-intervention

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Zachary Bercu, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: August 12, 2026
• First Submitted That Met QC Criteria: August 12, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Radiation
• Other Study ID Numbers: 2025P011985

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified radiation safety data by participant will be shared.
• IPD Sharing Time Frame: 3 month post publication to 5 years post publication
• IPD Sharing Access Criteria: Principal research investigators for radiation safety related analyses by direct email request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No