Radiation ExposureRAMPARTNCT05347290
Comparison Of Effective Radiation Shielding Between Rampart IC, M1128 Shield vs Conventional Apron And Shields In Clinical Interventional Procedures
A study testing Rampart IC, M1128, Lead Apron and Ancillary Shield and Rampart IC, M1128 and Lead Apron in people with Radiation Exposure, run by Northwell Health at 1 site in United States.
Trial summary
Previous studies have documented that orthopedic injuries and musculoskeletal pain are a likely result of wearing heavy leaded aprons. This single-center, randomized 1-3 month clinical study compares conventional lead aprons and ancillary shields to the Rampart IC, M1128 radiation protection system in order to improve… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- Rampart IC, M1128, Lead Apron and Ancillary Shield and Rampart IC, M1128 and Lead Apron
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 9 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants > 18 years of age.
- Interventional cardiology staff at Lenox Hill Hospital that are scheduled to work in Room C of the cardiac catheterization laboratory.
Who cannot join
- Pregnancy
- Unwilling to consent to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Effective Radiation Shielding Between A Portable, Configurable, Floor-Supported Radiation Protection System vs Conventional Apron And Shields In Clinical Interventional Procedures
Previous studies have documented that orthopedic injuries and musculoskeletal pain are a likely result of wearing heavy leaded aprons. This single-center, randomized 1-3 month clinical study compares conventional lead aprons and ancillary shields to the Rampart IC, M1128 radiation protection system in order to improve radiation safety with minimal orthopedic strain by using the RAMPART device. There will be three study arms, each arm requiring 21 procedures for a total of 63 total procedures, Each procedure will be randomized, instead of individual subjects. Each enrolled subject may be involved in more than one procedure/case. Randomization stratification will be 1:1:1 to either Rampart shield only, lead apron and ancillary shield, or lead apron and Rampart Shield. Real-time dosimeters will be used in each procedure to measure radiation attenuation.
Read the detailed description
Previous studies have documented that orthopedic injuries and musculoskeletal pain are a likely result of wearing heavy leaded aprons that are designed to shield interventionalists and laboratory staff from radiation. A large, multicenter study found that interventional laboratory employees reported a 67% increase in the prevalence of musculoskeletal pain. Two Society of Cardiovascular Angiography and Intervention (SCAI) surveys were performed a decade apart in 2004 and 2014 which both showed similar results on the orthopedic complications on the operators who wear leaded apron protection. The surveys revealed a 60% incidence of orthopedic issues and operators who have been operating greater than 20 years in the Cath Lab compared to a 2.3% incidence of chronic spine problems in the general population. Interestingly, of the operators who had been in practice less than 5 years, 26% already had orthopedic complaints. The study also revealed that over a third of those surveyed had already had to take spine related periods of absence from the catheterization lab. Though in recent years focus on individual radiation attenuation technologies that support both attenuation and orthopedic safety have evolved, the emphasis has been on the operator. A solution has not existed to address radiation attenuation and orthopedic safety for the entire scrubbed interventional team with one system.
To address the challenge of radiation protection in this environment without the burden of wearing a heavy lead apron, Rampart IC, M1128 was created. Rampart IC, M1128 is a fully adjustable and portable system that provides radiation protection for operators and their team without having to wear a lead apron. This study will have three randomization arms, each arm requiring 21 procedures for a total of 63 total procedures. Randomization stratification will be based on procedure, not individual subject. Each enrolled subject may be involved in more than one procedure/case. Computer software will be utilized to randomize procedures in a 1:1:1 ratio to either lead apron with ancillary shield, Rampart IC, M1128, or lead apron with the Rampart IC, M1128. Real-time dosimeters will be placed on interventional staff's left temple, shoulder, and hip in order to measure radiation attenuation.
- Conditions
- Radiation Exposure
- Being tested
- Rampart IC, M1128, Lead Apron and Ancillary Shield, Rampart IC, M1128 and Lead Apron
- Keywords
- radiation, radiation exposure, interventional cardiology, cardiac catherization laboratory, cardiac cath lab, lead apron, RAMPART Shield, radiation protection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rampart IC, M1128Device
Also called Rampart Shield, Rampart, Rampart System, Rampart M1128
Rampart IC, M1128 aims to address the challenge of radiation protection in the cardiac catheterization laboratory without the burden of wearing a heavy lead apron. Rampart M1128 is a compactly designed, portable, fully adjustable system that provides radiation protection for interventionalists and their technicians. It has independently adjustable flexible panels, allowing interventionalists multiple vascular access points, including right radial, bi-lateral femoral, and bi-lateral pedal. Participants in this arm will conduct catherization procedures using only the Rampart System, and radiation exposure will be measured using real-time dosimeters.
Lead Apron and Ancillary ShieldDevice
Also called LAS, Lead Apron
Participating providers in this arm will use conventional skirt and vest, thyroid collar, and 100% use of 2 types of ancillary shields. Most wrap-around skirts and vests were (0.25-0.5 mm) Pb. Thyroid shields were 0.5 mm Pb equivalent. Under the table lead x 2. Radiation exposure will be measured using real-time dosimeters.
Rampart IC, M1128 and Lead ApronDevice
Participating providers will use both the lead apron and the Rampart Shield. Radiation exposure will be measured using real-time dosimeters.
| Study group | Role | What they receive |
|---|---|---|
| Lead Apron + Rampart IC, M1128 | Experimental | Consented providers will perform catherization procedures utilizing both lead apron and Rampart system. Radiation will be measured by dosimeters worn by the providers. Receives: Device: Rampart IC, M1128 and Lead Apron |
| Rampart M1128 IC, Only | Experimental | Consented providers will perform catherization procedures utilizing only the Rampart system. Radiation will be measured by dosimeters worn by the providers. Receives: Device: Rampart IC, M1128 |
| Lead Apron Only | Active comparator | This is the control group. Consented providers will perform catherization procedures utilizing only the lead apron and ancillary shields (lead skirt, vest, thyroid collar (all at least 0.5mm Pb) with use of under table lead per lab operating policy and mobile suspended lead-acrylic shield and lead glasses). Radiation will be measured by dosimeters worn by the providers. Receives: Device: Lead Apron and Ancillary Shield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radiation attenuation
Change in radiation attenuation as detected by dosimeter readings for staff assigned to each randomization stratification.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start9 Mar 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This single center randomized 1-3 month clinical study compares conventional lead aprons and ancillary shields to the Rampart IC, M1128 fully configurable, portable, floor supported system that provides radiation protection and orthopedic safety for operators and the scrubbed interventional team members. There will be three study arms, each arm requiring 21 procedures for a total of 63 total procedures. Each enrolled subject may be involved in more than one procedure/case. For all arms, subjects will wear real-time dosimeters on their right temple, shoulder, and hip, and values will be collected post-procedure.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Varinder Singh, Northwell Health
- Investigators
- Varinder P Singh, M.D., Principal investigator, Senior Vice President, Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347290
- Sponsor's protocol ID
- 21-1302
- Acronym
- RAMPART
- Status last verified
- Feb 2023
- First submitted
- 31 Mar 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Andreassi MG, Piccaluga E, Guagliumi G, Del Greco M, Gaita F, Picano E. Occupational Health Risks in Cardiac Catheterization Laboratory Workers. Circ Cardiovasc Interv. 2016 Apr;9(4):e003273. doi: 10.1161/CIRCINTERVENTIONS.115.003273.
PubMed 27072525Zakeri F, Hirobe T, Akbari Noghabi K. Biological effects of low-dose ionizing radiation exposure on interventional cardiologists. Occup Med (Lond). 2010 Sep;60(6):464-9. doi: 10.1093/occmed/kqq062. Epub 2010 Jun 2.
PubMed 20519631Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA. Occupational health hazards in the interventional laboratory: time for a safer environment. Radiology. 2009 Feb;250(2):538-44. doi: 10.1148/radiol.2502082558.
PubMed 19188321Picano E, Vano E. The radiation issue in cardiology: the time for action is now. Cardiovasc Ultrasound. 2011 Nov 21;9:35. doi: 10.1186/1476-7120-9-35.
PubMed 22104562Orme NM, Rihal CS, Gulati R, Holmes DR Jr, Lennon RJ, Lewis BR, McPhail IR, Thielen KR, Pislaru SV, Sandhu GS, Singh M. Occupational health hazards of working in the interventional laboratory: a multisite case control study of physicians and allied staff. J Am Coll Cardiol. 2015 Mar 3;65(8):820-826. doi: 10.1016/j.jacc.2014.11.056.
PubMed 25720626Goldstein JA, Balter S, Cowley M, Hodgson J, Klein LW; Interventional Committee of the Society of Cardiovascular Interventions. Occupational hazards of interventional cardiologists: prevalence of orthopedic health problems in contemporary practice. Catheter Cardiovasc Interv. 2004 Dec;63(4):407-11. doi: 10.1002/ccd.20201.
PubMed 15558765Klein LW, Tra Y, Garratt KN, Powell W, Lopez-Cruz G, Chambers C, Goldstein JA; Society for Cardiovascular Angiography and Interventions. Occupational health hazards of interventional cardiologists in the current decade: Results of the 2014 SCAI membership survey. Catheter Cardiovasc Interv. 2015 Nov;86(5):913-24. doi: 10.1002/ccd.25927. Epub 2015 Mar 24.
PubMed 25810341Hirshfeld JW Jr, Balter S, Brinker JA, Kern MJ, Klein LW, Lindsay BD, Tommaso CL, Tracy CM, Wagner LK, Creager MA, Elnicki M, Lorell BH, Rodgers GP, Weitz HH; American College of Cardiology Foundation; American Heart Association/; HRS; SCAI; American College of Physicians Task Force on Clinical Competence and Training. ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training. Circulation. 2005 Feb 1;111(4):511-32. doi: 10.1161/01.CIR.0000157946.29224.5D. No abstract available.
PubMed 15687141Ross AM, Segal J, Borenstein D, Jenkins E, Cho S. Prevalence of spinal disc disease among interventional cardiologists. Am J Cardiol. 1997 Jan 1;79(1):68-70. doi: 10.1016/s0002-9149(96)00678-9.
PubMed 9024739
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Effective Radiation Shielding Between A Portable, Configurable, Floor-Supported Radiation Protection System vs Conventional Apron And Shields In Clinical Interventional Procedures
- ClinicalTrials.gov ID
- NCT05347290
- Acronym / sponsor ID
- RAMPART / 21-1302
- Conditions
- Radiation Exposure
- Keywords
- radiation, radiation exposure, interventional cardiology, cardiac catherization laboratory, cardiac cath lab, lead apron, RAMPART Shield, radiation protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 26 Apr 2022 (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.
Previous studies have documented that orthopedic injuries and musculoskeletal pain are a likely result of wearing heavy leaded aprons. This single-center, randomized 1-3 month clinical study compares conventional lead aprons and ancillary shields to the Rampart IC, M1128 radiation protection system in order to improve radiation safety with minimal orthopedic strain by using the RAMPART device. There will be three study arms, each arm requiring 21 procedures for a total of 63 total procedures, Each procedure will be randomized, instead of individual subjects. Each enrolled subject may be involved in more than one procedure/case. Randomization stratification will be 1:1:1 to either Rampart shield only, lead apron and ancillary shield, or lead apron and Rampart Shield. Real-time dosimeters will be used in each procedure to measure radiation attenuation.
Detailed description
Previous studies have documented that orthopedic injuries and musculoskeletal pain are a likely result of wearing heavy leaded aprons that are designed to shield interventionalists and laboratory staff from radiation. A large, multicenter study found that interventional laboratory employees reported a 67% increase in the prevalence of musculoskeletal pain. Two Society of Cardiovascular Angiography and Intervention (SCAI) surveys were performed a decade apart in 2004 and 2014 which both showed similar results on the orthopedic complications on the operators who wear leaded apron protection. The surveys revealed a 60% incidence of orthopedic issues and operators who have been operating greater than 20 years in the Cath Lab compared to a 2.3% incidence of chronic spine problems in the general population. Interestingly, of the operators who had been in practice less than 5 years, 26% already had orthopedic complaints. The study also revealed that over a third of those surveyed had already had to take spine related periods of absence from the catheterization lab. Though in recent years focus on individual radiation attenuation technologies that support both attenuation and orthopedic safety have evolved, the emphasis has been on the operator. A solution has not existed to address radiation attenuation and orthopedic safety for the entire scrubbed interventional team with one system.
To address the challenge of radiation protection in this environment without the burden of wearing a heavy lead apron, Rampart IC, M1128 was created. Rampart IC, M1128 is a fully adjustable and portable system that provides radiation protection for operators and their team without having to wear a lead apron. This study will have three randomization arms, each arm requiring 21 procedures for a total of 63 total procedures. Randomization stratification will be based on procedure, not individual subject. Each enrolled subject may be involved in more than one procedure/case. Computer software will be utilized to randomize procedures in a 1:1:1 ratio to either lead apron with ancillary shield, Rampart IC, M1128, or lead apron with the Rampart IC, M1128. Real-time dosimeters will be placed on interventional staff's left temple, shoulder, and hip in order to measure radiation attenuation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This single center randomized 1-3 month clinical study compares conventional lead aprons and ancillary shields to the Rampart IC, M1128 fully configurable, portable, floor supported system that provides radiation protection and orthopedic safety for operators and the scrubbed interventional team members. There will be three study arms, each arm requiring 21 procedures for a total of 63 total procedures. Each enrolled subject may be involved in more than one procedure/case. For all arms, subjects will wear real-time dosimeters on their right temple, shoulder, and hip, and values will be collected post-procedure.
| Arm | Type | Receives |
|---|---|---|
| Lead Apron + Rampart IC, M1128 | Experimental | Device: Rampart IC, M1128 and Lead ApronConsented providers will perform catherization procedures utilizing both lead apron and Rampart system. Radiation will be measured by dosimeters worn by the providers. |
| Rampart M1128 IC, Only | Experimental | Device: Rampart IC, M1128Consented providers will perform catherization procedures utilizing only the Rampart system. Radiation will be measured by dosimeters worn by the providers. |
| Lead Apron Only | Active comparator | Device: Lead Apron and Ancillary ShieldThis is the control group. Consented providers will perform catherization procedures utilizing only the lead apron and ancillary shields (lead skirt, vest, thyroid collar (all at least 0.5mm Pb) with use of under table lead per lab operating policy and mobile suspended lead-acrylic shield and lead glasses). Radiation will be measured by dosimeters worn by the providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants > 18 years of age.
- Interventional cardiology staff at Lenox Hill Hospital that are scheduled to work in Room C of the cardiac catheterization laboratory.
Key exclusion criteria (2 listed)
- Pregnancy
- Unwilling to consent to the study protocol.
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, M1128Also: Rampart Shield, Rampart, Rampart System, Rampart M1128Rampart IC, M1128 aims to address the challenge of radiation protection in the cardiac catheterization laboratory without the burden of wearing a heavy lead apron. Rampart M1128 is a compactly designed, portable, fully adjustable system that provides radiation protection for interventionalists and their technicians. It has independently adjustable flexible panels, allowing interventionalists multiple vascular access points, including right radial, bi-lateral femoral, and bi-lateral pedal. Participants in this arm will conduct catherization procedures using only the Rampart System, and radiation exposure will be measured using real-time dosimeters. | Device | Rampart M1128 IC, Only |
| Lead Apron and Ancillary ShieldAlso: LAS, Lead ApronParticipating providers in this arm will use conventional skirt and vest, thyroid collar, and 100% use of 2 types of ancillary shields. Most wrap-around skirts and vests were (0.25-0.5 mm) Pb. Thyroid shields were 0.5 mm Pb equivalent. Under the table lead x 2. Radiation exposure will be measured using real-time dosimeters. | Device | Lead Apron Only |
| Rampart IC, M1128 and Lead ApronParticipating providers will use both the lead apron and the Rampart Shield. Radiation exposure will be measured using real-time dosimeters. | Device | Lead Apron + Rampart IC, M1128 |
Primary outcome
Change in radiation attenuation
Time frame: 90 days
Change in radiation attenuation as detected by dosimeter readings for staff assigned to each randomization stratification.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Background: PubMed 27072525Andreassi MG, Piccaluga E, Guagliumi G, Del Greco M, Gaita F, Picano E. Occupational Health Risks in Cardiac Catheterization Laboratory Workers. Circ Cardiovasc Interv. 2016 Apr;9(4):e003273. doi: 10.1161/CIRCINTERVENTIONS.115.003273.
- Background: PubMed 20519631Zakeri F, Hirobe T, Akbari Noghabi K. Biological effects of low-dose ionizing radiation exposure on interventional cardiologists. Occup Med (Lond). 2010 Sep;60(6):464-9. doi: 10.1093/occmed/kqq062. Epub 2010 Jun 2.
- Background: PubMed 19188321Klein LW, Miller DL, Balter S, Laskey W, Haines D, Norbash A, Mauro MA, Goldstein JA. Occupational health hazards in the interventional laboratory: time for a safer environment. Radiology. 2009 Feb;250(2):538-44. doi: 10.1148/radiol.2502082558.
- Background: PubMed 22104562Picano E, Vano E. The radiation issue in cardiology: the time for action is now. Cardiovasc Ultrasound. 2011 Nov 21;9:35. doi: 10.1186/1476-7120-9-35.
- Background: PubMed 25720626Orme NM, Rihal CS, Gulati R, Holmes DR Jr, Lennon RJ, Lewis BR, McPhail IR, Thielen KR, Pislaru SV, Sandhu GS, Singh M. Occupational health hazards of working in the interventional laboratory: a multisite case control study of physicians and allied staff. J Am Coll Cardiol. 2015 Mar 3;65(8):820-826. doi: 10.1016/j.jacc.2014.11.056.
- Background: PubMed 15558765Goldstein JA, Balter S, Cowley M, Hodgson J, Klein LW; Interventional Committee of the Society of Cardiovascular Interventions. Occupational hazards of interventional cardiologists: prevalence of orthopedic health problems in contemporary practice. Catheter Cardiovasc Interv. 2004 Dec;63(4):407-11. doi: 10.1002/ccd.20201.
- Background: PubMed 25810341Klein LW, Tra Y, Garratt KN, Powell W, Lopez-Cruz G, Chambers C, Goldstein JA; Society for Cardiovascular Angiography and Interventions. Occupational health hazards of interventional cardiologists in the current decade: Results of the 2014 SCAI membership survey. Catheter Cardiovasc Interv. 2015 Nov;86(5):913-24. doi: 10.1002/ccd.25927. Epub 2015 Mar 24.
- Background: PubMed 15687141Hirshfeld JW Jr, Balter S, Brinker JA, Kern MJ, Klein LW, Lindsay BD, Tommaso CL, Tracy CM, Wagner LK, Creager MA, Elnicki M, Lorell BH, Rodgers GP, Weitz HH; American College of Cardiology Foundation; American Heart Association/; HRS; SCAI; American College of Physicians Task Force on Clinical Competence and Training. ACCF/AHA/HRS/SCAI clinical competence statement on physician knowledge to optimize patient safety and image quality in fluoroscopically guided invasive cardiovascular procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training. Circulation. 2005 Feb 1;111(4):511-32. doi: 10.1161/01.CIR.0000157946.29224.5D. No abstract available.
- Background: PubMed 9024739Ross AM, Segal J, Borenstein D, Jenkins E, Cho S. Prevalence of spinal disc disease among interventional cardiologists. Am J Cardiol. 1997 Jan 1;79(1):68-70. doi: 10.1016/s0002-9149(96)00678-9.
- Rampart IC, M1128 websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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. This study is not recruiting at the moment.
Varinder P Singh, M.D. principal investigator
Senior Vice President, Cardiology
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, M1128, Lead Apron and Ancillary Shield and Rampart IC, M1128 and Lead Apron in people with Radiation Exposure, run by Northwell Health 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 2 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: finished, as of the sponsor's last update on 3 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in radiation attenuation (time frame: 90 days). 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 NCT05347290, which also lists 9 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 3 Feb 2023.