Clinical Evaluation of a Novel Textile Radiation Protection Device

NCT07768605 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2025P011985
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Radiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Role-specific radiation dose

  Baseline, 4 and 8 weeks post-intervention

• Procedure-specific radiation dose

  Baseline, 4 and 8 weeks post-intervention

• Radiation dose and attenuation stratified by fluoroscopy room

  Baseline, 4 and 8 weeks post-intervention

• Number of participants with correct donning/doffing placement of the PPE

  Baseline, 4 and 8 weeks post-intervention

Study Arms (2)

Group A: Standard Personal Protective Equipment (PPE) only then Texray PPE

EXPERIMENTAL

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; Device: Texray PPE

Texray PPE then Standard PPE only

EXPERIMENTAL

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; Device: Texray PPE

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.

Group A: Standard Personal Protective Equipment (PPE) only then Texray PPE; Texray PPE then Standard PPE only

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.

Group A: Standard Personal Protective Equipment (PPE) only then Texray PPE; Texray PPE then Standard PPE only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Winship Cancer Institute

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Study Officials

• Zachary Bercu, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Kassin, MD

CONTACT

770-712-6913; michael.t.kassin@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 month post publication to 5 years post publication
• Access Criteria: Principal research investigators for radiation safety related analyses by direct email request.

Locations

US (3)