Clinical Evaluation of a Novel Textile Radiation Protection Device

ConditionRadiation Exposure

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

Standard PPE
Device
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
Device
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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Group A: Standard Personal Protective Equipment (PPE) only then Texray PPEExperimental treatment 2 interventions

Group B: Texray PPE then Standard PPE onlyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame