Clinical Evaluation of a Novel Textile Radiation Protection Device

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07768605
Status
Not Yet Recruiting

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Conditions

  • Radiation Exposure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 17, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • 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.
  • 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.

Primary Outcome Measure

Radiation dose comparing standard PPE vs. Texray PPE groups [ Time Frame: Baseline, 4 and 8 weeks post-intervention ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Michael U Kassin, MD
[email protected]
770-712-6913
Emory University Hospital MidtownAtlantaGeorgia30308
Michael UH Kassin, MD
[email protected]
770-712-6913
Emory UH Midtown
Winship Cancer InstituteAtlantaGeorgia30308
Michael UH Kassin, MD
[email protected]
770-712-6913
Emory UH Midtown

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By research site
Emory University Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAWinship Cancer Institute· Atlanta, GA

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