Clinical Evaluation of a Novel Textile Radiation Protection Device

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.

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.