Radiation ProtectionSECURENCT07467720
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction: Multi-site Rampart Guardian Peripheral Trial
A study testing Rampart IC System in people with Radiation Protection, run by Baylor Research Institute at 1 site in United States.
Trial summary
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radiation Protection
- What is being tested?
- Rampart IC System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2026to 15 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Member of the interventional care team
- Elective peripheral procedure
- The access site is the femoral artery
- The treatment area is at or distal to the iliac artery
Who cannot join
- Individuals who are not yet adults, pregnant women, or prisoners.
- Urgent and emergent cases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Hale contact
United States1 site, 1 recruiting
- Recruiting
Baylor Scott & White The Heart Hospital- Plano
Plano, Texas, 75093
Bonnie Ostergren, 469-814-4181, bonnie.ostergren@bswhealth.org
About this study
Official title: Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
Read the detailed description
An Investigator initiated, prospective, randomized, multi-site study to evaluate the clinical utility of radiation exposure reduction.
- Conditions
- Radiation Protection
- Being tested
- Rampart IC System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rampart IC SystemDevice
RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) is a radiation protection system that the study team will use during peripheral cases.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Lead Apron and Shields | No intervention | These procedures will be have no intervention. The study team will use the traditional lead apron and shields in peripheral cases. |
| Rampart IC System | Active comparator | The study team will use the Rampart IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases. Receives: Device: Rampart IC System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge.
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge. The two methods being compared are traditional lead aprons and shields and the RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.
Measured: Intraprocedural
Secondary outcomes (1)
The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge.
The secondary endpoint will be to compare radiation exposure on a per body segment analysis on the care team using a Raysafe i3 dosimeter badge. The investigators will compare traditional lead aprons and ancillary shields to the RAMPART IC System with optional lead aprons.
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start20 Aug 2026
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radiation ProtectionStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467720
- Sponsor's protocol ID
- 026-232
- Acronym
- SECURE
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA; Joint Inter-Society Task Force on Occupational Hazards in the Interventional Laboratory. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):432-8. doi: 10.1002/ccd.21801.
PubMed 19214981Occ Med. 2010;60(6):464-9
Circulation: Cardiovascular Interventions. 2016,Volume: 9, Issue: 4, DOI: 10.1161/CIRCINTERVENTIONS.115.003273
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
- ClinicalTrials.gov ID
- NCT07467720
- Acronym / sponsor ID
- SECURE / 026-232
- Conditions
- Radiation Protection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 12 Mar 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.
Study to Evaluate the Clinical Utility of Radiation Exposure Reduction (SECURE): Multi-site Rampart Guardian Peripheral Trial
Detailed description
An Investigator initiated, prospective, randomized, multi-site study to evaluate the clinical utility of radiation exposure reduction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Lead Apron and Shields | No intervention | –These procedures will be have no intervention. The study team will use the traditional lead apron and shields in peripheral cases. |
| Rampart IC System | Active comparator | Device: Rampart IC SystemThe study team will use the Rampart IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Member of the interventional care team
- Elective peripheral procedure
- The access site is the femoral artery
- The treatment area is at or distal to the iliac artery
Key exclusion criteria (2 listed)
- Individuals who are not yet adults, pregnant women, or prisoners.
- Urgent and emergent cases
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 |
|---|---|---|
| Rampart IC SystemRAMPART IC System (Guardian, Bunker, Shadow, and Sentry) is a radiation protection system that the study team will use during peripheral cases. | Device | Rampart IC System |
Primary outcome
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge.
Time frame: Intraprocedural
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge. The two methods being compared are traditional lead aprons and shields and the RAMPART IC System (Guardian, Bunker, Shadow, and Sentry) with optional lead aprons in peripheral cases.
1 secondary outcome
The difference in radiation exposure to the care team on a per body segment analysis using a Raysafe i3 dosimeter badge.
Time frame: Intraprocedural
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 21 Aug 2026.
- Background: PubMed 19214981Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA; Joint Inter-Society Task Force on Occupational Hazards in the Interventional Laboratory. Occupational health hazards in the interventional laboratory: time for a safer environment. Catheter Cardiovasc Interv. 2009 Feb 15;73(3):432-8. doi: 10.1002/ccd.21801.
- BackgroundOcc Med. 2010;60(6):464-9
- BackgroundCirculation: Cardiovascular Interventions. 2016,Volume: 9, Issue: 4, DOI: 10.1161/CIRCINTERVENTIONS.115.003273
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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.
Sarah Hale contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rampart IC System in people with Radiation Protection, run by Baylor Research Institute at 1 site 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 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 1 site 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 Bonnie Ostergren (469-814-4181, bonnie.ostergren@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in radiation exposure to the care team using a Raysafe i3 dosimeter badge. (time frame: Intraprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07467720, which also lists 3 linked publications.
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 21 Aug 2026.