RADPAD for Reducing Radiation Exposure

Overseen By Giorgio A. Medranda, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnant, Breastfeeding, Unwilling to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 day per procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a product called RADPAD to determine if it can reduce radiation exposure for healthcare workers performing heart procedures. These procedures occur in a cardiac catheterization lab, where doctors and assistants work near radiation sources. The trial compares the use of RADPAD, a protective pad, with standard radiation safety measures. Suitable participants include healthcare professionals such as cardiologists and physician assistants who work close to radiation during these heart procedures. As an unphased trial, this study allows healthcare workers to contribute to enhancing safety measures in their field.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the RADPAD is safe for use in cardiac catheterization procedures?

Research has shown that the RADPAD, tested in several studies, effectively reduces scatter radiation exposure in heart procedure labs. The RADPAD is a lead-free, disposable shield that protects medical staff from radiation. Studies have found it to be generally well-tolerated, with no major side effects reported. This indicates that the RADPAD is safe for use in situations where radiation exposure is a concern. Independent testing has proven that the product lowers radiation exposure, making it a promising safety option in lab settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RADPAD trial because it explores a new method to reduce radiation exposure during cardiac catheterization procedures, a common concern in interventional cardiology. Unlike traditional radiation protection gear that primarily shields the body, the RADPAD is designed to provide an added layer of defense by being placed directly on the patient, potentially reducing scatter radiation. This trial aims to find out if RADPAD can make a significant difference in protecting healthcare workers from radiation, offering a simple yet potentially impactful enhancement to current safety protocols.

What evidence suggests that the RADPAD is effective for reducing radiation exposure?

Studies have shown that the RADPAD protection drape can greatly reduce radiation exposure for medical staff in heart procedure labs. In this trial, one group will use the RADPAD shielding, which research indicates results in much lower radiation doses compared to not using it. This protection proves especially effective during common procedures like heart artery treatments and pacemaker placements. In real-world use, RADPAD has consistently lowered radiation exposure for medical staff, making it a promising tool for improving safety in these procedures. Another group in this trial will undergo procedures without the use of RADPAD, following the standard radiation protocol. ^{2 5 6 7 8}

Who Is on the Research Team?

Giorgio A. Medranda, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

The ATTENUATE trial is for healthcare professionals like physician assistants, cardiology fellows, and interventional cardiologists who perform cardiac catheterization procedures at NYU Langone Hospital - Long Island. Participants must be over 18 years old and able to give consent.

Inclusion Criteria

I am willing and able to give my consent.

I am scheduled for a heart catheterization procedure at NYU Langone Hospital - Long Island.

I am the main operator in cardiac catheterization procedures at NYU Langone Hospital - Long Island.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Cardiac catheterization procedures are performed with and without the RADPAD to assess radiation exposure

Up to 1 day per procedure

Multiple procedures per operator

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RADPAD

Trial Overview This study tests the RADPAD's effectiveness in reducing radiation exposure to medical staff during heart-related catheterization procedures. It involves comparing standard radiation safety measures with and without the use of RADPAD in a large-scale, randomized controlled trial.

How Is the Trial Designed?

Group I: RADPAD Experimental Treatment 1 Intervention

Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and a single RADPAD will be placed on the patient. All employee participants will wear a radiation detection device at the level of the left side of the chest facing the radiation source over any the protective apron worn by the participant.

Group II: No RADPAD Active Control 1 Intervention

Each cardiac catheterization procedure utilizes the standard guideline directed radiation protocol and no RADPAD will be used. All employee participants will wear a radiation detection device at the level of the left side of the chest facing the radiation source over any the protective apron worn by the participant.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

The use of the RadPad™ radiation-attenuating drape during cardiac resynchronization therapy (CRT) procedures significantly reduces radiation exposure to physicians, with a 65% reduction for hands and body and a 40% reduction for eyes.

No technical issues or acute skin reactions were reported with the RadPad™, and its application took less than 30 seconds, suggesting it is a safe and practical option for enhancing safety during CRT procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of using a bismuth-containing, radiation-absorbing drape in cardiac resynchronization implant procedures. Jones, MA., Cocker, M., Khiani, R., et al.[2019]

The RADPAD surgical drape significantly reduces radiation exposure to primary operators during routine diagnostic coronary angiography, with a 59% reduction in total radiation exposure and a 47% reduction in the radiation exposure rate.

In a study involving 60 patients, the primary operator's radiation dose was significantly lower when using the RADPAD (8.0 µSv) compared to the control group (19.6 µSv), indicating its efficacy in protecting healthcare staff from ionizing radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of RADPAD protective drape during coronary angiography. Kherad, B., Jerichow, T., Blaschke, F., et al.[2019]

The use of RADPAD surgical drapes during percutaneous coronary interventions (PCI) significantly reduced radiation exposure to the primary operator, with a mean dose of 3.679 mrem compared to 8.12 mrem in the control group, indicating a strong efficacy in protecting medical staff.

This study, involving 53 patients, demonstrates that RADPAD not only lowers radiation doses for operators but also supports the safety of using radiation-absorbing equipment in clinical settings, making it a recommended practice during coronary angioplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in Primary Operator Radiation Dose Exposure During Coronary Angioplasty Using Radiation Absorbing Drape. Sharma, AB., Agrawal, R.[2023]

In a study involving 137 patients undergoing coronary angiography and percutaneous coronary intervention, the use of RADPAD significantly reduced radiation exposure for the primary operator (PO) compared to procedures without it, with reductions in dose relative to various measures (CAST, DAP, and AK).

The findings also indicated that secondary operators (SO) experienced similar reductions in radiation exposure when RADPAD was used, highlighting its effectiveness in enhancing safety during fluoroscopic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimizing scattered radiation dose in cardiac catheterization laboratory during interventional procedures using lead free drape - MILD study. Bhat, KG., Guleria, VS., Singla, M., et al.[2022]

In a randomized study of 60 patients undergoing coronary angiography, the use of the Radpad radiation shield significantly reduced the operator's radiation exposure by 23%, despite similar procedure times and total examination doses.

The Radpad shield provided consistent reductions in radiation exposure across various body locations, ranging from 13% to 34%, highlighting its effectiveness in protecting healthcare workers during interventional procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield. Politi, L., Biondi-Zoccai, G., Nocetti, L., et al.[2022]

The use of RADPAD during complex percutaneous coronary interventions (PCI) significantly reduced radiation exposure to operators by 39%, despite similar fluoroscopy times and total radiation doses compared to procedures without RADPAD.

Among different angiographic projections, the Left Anterior Oblique (LAO) views emitted significantly higher radiation doses, highlighting the need for enhanced radiation protection in these orientations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of RADPAD protection drape in reducing radiation exposure in the catheterization laboratory-First Indian study. Shah, P., Khanna, R., Kapoor, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11132176/

Assessing the Efficacy of RADPAD Protection Drape in ... We conducted a systematic review and meta-analysis to determine the effectiveness of RADPAD protection drapes in the cardiac catheterization lab.

2. radpad.com radpad.com/efficacy-of-radpad-protection-drapes-in-reducing-radiation-exposure-in-the-catheterization-laboratory/

Efficacy of RADPAD protection drapes in reducing ... Results found that when using RADPAD shielding, the primary operator and staff's radiation doses were significantly lower than no-RADPAD testing. RADPAD® ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6310698/

Efficacy of RADPAD protection drape in reducing radiation ... It has been shown to reduce radiation exposure in routine PCI procedures, pacemaker & device implantations such as cardiac resynchronization therapy and also ...

4. crtonline.org crtonline.org/news-detail/new-newsrelease-2000

RADPAD Sheild Provides Extra Protection Against ... RADPAD Sheild Provides Extra Protection Against Radiation in Cardiac Cath Lab: ATTENUATE Trial. Posted: 03/08/2025; Author: Bailey G. Salimes, ...

5. acadianmed.com acadianmed.com/wp-content/uploads/2019/05/Efficacy-of-the-RADPAD-Protection-Drape-in-Reducing-Operators%E2%80%99-Radiation-Exposure-in-the-Catheterization-Laboratory.pdf

Efficacy-of-the-RADPAD-Protection-Drape-in-Reducing- ... Conclusions—In clinical daily practice, the standard use of the RADPAD radiation shield reduced operator radiation exposure compared with procedures with NOPAD ...

6. radpad.com radpad.com/

Scatter Radiation Protection|RADPAD Scatter Radiation ... Step into the shade zone with RADPAD® Protection. Disposable, Clinically Proven, Eco-Friendly. Contact us for your free scatter radiation evaluation.

7. radpad.com radpad.com/products/

Radiation Protection Shields|Scatter Radiation Drapes RADPAD Lead-free, disposable Scatter Radiation Sheilds & Drapes for Cardiac Cath Lab, Electrophysiology Lab, Endovascular Surgery, Interventional Radiology.

8. radpad.com radpad.com/wp-content/uploads/2021/02/RADPAD-Brochure.pdf

Radiation Protection Products Our products have been independently tested, studied, and proven to be effective in reducing scatter radiation exposure. Page 3. RADPAD® Shields absorb ...