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Clinical Evaluation of a Novel Textile Radiation Protection Device

NCT07768605 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-17

No results posted yet for this study

Summary

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.

Conditions

  • Radiation Exposure

Interventions

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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Zachary Bercu, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768605 on ClinicalTrials.gov