Radiation ExposureNCT07768605
Clinical Evaluation of a Novel Textile Radiation Protection Device
A study testing Standard PPE and Texray PPE in people with Radiation Exposure, run by Emory University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- Standard PPE and Texray PPE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Michael UH Kassin, MD, 770-712-6913, michael.t.kassin@emory.edu
Emory UH Midtown
Winship Cancer Institute
Atlanta, Georgia, 30308
Michael UH Kassin, MD, 770-712-6913, michael.t.kassin@emory.edu
Emory UH Midtown
Emory University Hospital
Atlanta, Georgia, 30322
Michael U Kassin, MD, 770-712-6913, michael.t.kassin@emory.edu
About this study
Official title: Evaluation of Novel Woven Fabric Radiation Protection Gear for Head and Neck Regions for Interventional Radiology Personnel
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.
Read the detailed description
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.
- Conditions
- Radiation Exposure
- Being tested
- Standard PPE, Texray PPE
- Keywords
- Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PPEDevice
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 PPEDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard PPE; Device: Texray PPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 and 8 weeks post-intervention
Secondary outcomes (4)
Role-specific radiation dose
Role-specific radiation dose in mSv will be measured (attending IR, trainee, technologist, nurse, anesthesia) comparing standard PPE vs. Texray PPE groups.
Measured: Baseline, 4 and 8 weeks post-intervention
Procedure-specific radiation dose
Procedure-specific radiation dose in mSv (e.g., liver-directed therapy, embolization, venography, line and port placement) will be measured comparing standard PPE vs. Texray PPE groups.
Measured: Baseline, 4 and 8 weeks post-intervention
Radiation dose and attenuation stratified by fluoroscopy room
Radiation dose will be measured comparing standard PPE vs. Texray PPE groups stratified by fluoroscopy room and equipment age (new vs. legacy systems).
Measured: Baseline, 4 and 8 weeks post-intervention
Number of participants with correct donning/doffing placement of the PPE
Number of participants with correct PPE donning/doffing will be recorded.
Measured: Baseline, 4 and 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zachary Bercu, Emory University
- Investigators
- Zachary Bercu, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768605
- Sponsor's protocol ID
- 2025P011985
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified radiation safety data by participant will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Woven Fabric Radiation Protection Gear for Head and Neck Regions for Interventional Radiology Personnel
- ClinicalTrials.gov ID
- NCT07768605
- Acronym / sponsor ID
- 2025P011985
- Conditions
- Radiation Exposure
- Keywords
- Radiation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard Personal Protective Equipment (PPE) only then Texray PPE | Experimental | Device: Standard PPE, Device: Texray PPEParticipants 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. |
| Texray PPE then Standard PPE only | Experimental | Device: Standard PPE, Device: Texray PPEParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard PPEStandard 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 | Group A: Standard Personal Protective Equipment (PPE) only then Texray PPE, Texray PPE then Standard PPE only |
| Texray PPETexray 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. | Device | Group A: Standard Personal Protective Equipment (PPE) only then Texray PPE, Texray PPE then Standard PPE only |
Primary outcome
Radiation dose comparing standard PPE vs. Texray PPE groups
Time frame: Baseline, 4 and 8 weeks post-intervention
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.
4 secondary outcomes
Role-specific radiation dose
Time frame: Baseline, 4 and 8 weeks post-intervention
Procedure-specific radiation dose
Time frame: Baseline, 4 and 8 weeks post-intervention
Radiation dose and attenuation stratified by fluoroscopy room
Time frame: Baseline, 4 and 8 weeks post-intervention
Number of participants with correct donning/doffing placement of the PPE
Time frame: Baseline, 4 and 8 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified radiation safety data by participant will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zachary Bercu, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard PPE and Texray PPE in people with Radiation Exposure, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Kassin, MD (770-712-6913, michael.t.kassin@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose comparing standard PPE vs. Texray PPE groups (time frame: Baseline, 4 and 8 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.