Exposure of Member of Staff to Medical Diagnostic X-RayESPRESSONCT03634657
EffectivenesS of Additional X-ray PRotection dEviceS in Reducing Scattered Radiation in Radial interventiOn
A study testing Plain X-ray protection shield, Protection shield & X-ray protective strips and Protection shield & protective strips & patient cut-outs in people with Exposure of Member of Staff to Medical Diagnostic X-Ray, run by Tommaso Gori at 1 site in Germany.
Trial summary
This study evaluates the radiation exposure of scattered radiation for the interventionalist during coronary angiography using different X-ray protection materials, namely, an X-ray Screen without additional X-ray protection, an X-ray Screen with additional protective strips and an X-ray Screen with additional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exposure of Member of Staff to Medical Diagnostic X-Ray
- What is being tested?
- Plain X-ray protection shield, Protection shield & X-ray protective strips and Protection shield & protective strips & patient cut-outs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- 16 Aug 2018to 1 Oct 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for coronary angiography
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Wirksamkeit Additiver Strahlenschutzvorrichtungen Zwecks Reduzierung Der Ionisierenden Streustrahlung im Herzkatheterlabor
This study evaluates the radiation exposure of scattered radiation for the interventionalist during coronary angiography using different X-ray protection materials, namely, an X-ray Screen without additional X-ray protection, an X-ray Screen with additional protective strips and an X-ray Screen with additional protective strips AND protective patient cut-outs.
- Being tested
- Plain X-ray protection shield, Protection shield & X-ray protective strips, Protection shield & protective strips & patient cut-outs
- Keywords
- Scattered radiation, X-ray protection, Radiation in cath lab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plain X-ray protection shieldRadiation
Coronary angiography with mere X-ray protection shield
Protection shield & X-ray protective stripsRadiation
Coronary angiography with X-ray protection shield \& X-ray protective strips
Protection shield & protective strips & patient cut-outsRadiation
Coronary angiography with X-ray protection shield \& X-ray protective strips \& X-ray protection patient cut-outs
| Study group | Role | What they receive |
|---|---|---|
| Plain X-ray protection shield | Active comparator | Not described Receives: Radiation: Plain X-ray protection shield |
| Protection shield & X-ray protective strips | Experimental | Not described Receives: Radiation: Protection shield & X-ray protective strips |
| Protection shield & protective strips & patient cut-outs | Experimental | Not described Receives: Radiation: Protection shield & protective strips & patient cut-outs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator dose
Dose of radiation measured
Measured: Duration of coronary angiography of individuel patient, varies between approximately 5 minutes of radiation (easy access, exclusion coronary heart disease) and app. 3 hours (difficult and complex percutaneous coronary intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start16 Aug 2018
- Primary completion31 Dec 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exposure of Member of Staff to Medical Diagnostic X-RayStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tommaso Gori
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tommaso Gori, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634657
- Sponsor's protocol ID
- ESPRESSO
- Acronym
- ESPRESSO
- Status last verified
- Oct 2020
- First submitted
- 8 Aug 2018
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial. EuroIntervention. 2020 Oct 23;16(8):663-671. doi: 10.4244/EIJ-D-19-00945.
PubMed 32338611Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial. BMJ Open. 2019 Jul 3;9(7):e029509. doi: 10.1136/bmjopen-2019-029509.
PubMed 31272982
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wirksamkeit Additiver Strahlenschutzvorrichtungen Zwecks Reduzierung Der Ionisierenden Streustrahlung im Herzkatheterlabor
- ClinicalTrials.gov ID
- NCT03634657
- Acronym / sponsor ID
- ESPRESSO / ESPRESSO
- Keywords
- Scattered radiation, X-ray protection, Radiation in cath lab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Tommaso GoriUniversity, hospital or other
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 16 Aug 2018 (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 evaluates the radiation exposure of scattered radiation for the interventionalist during coronary angiography using different X-ray protection materials, namely, an X-ray Screen without additional X-ray protection, an X-ray Screen with additional protective strips and an X-ray Screen with additional protective strips AND protective patient cut-outs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plain X-ray protection shield | Active comparator | Radiation: Plain X-ray protection shield |
| Protection shield & X-ray protective strips | Experimental | Radiation: Protection shield & X-ray protective strips |
| Protection shield & protective strips & patient cut-outs | Experimental | Radiation: Protection shield & protective strips & patient cut-outs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for coronary angiography
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Plain X-ray protection shieldCoronary angiography with mere X-ray protection shield | Radiation | Plain X-ray protection shield |
| Protection shield & X-ray protective stripsCoronary angiography with X-ray protection shield \& X-ray protective strips | Radiation | Protection shield & X-ray protective strips |
| Protection shield & protective strips & patient cut-outsCoronary angiography with X-ray protection shield \& X-ray protective strips \& X-ray protection patient cut-outs | Radiation | Protection shield & protective strips & patient cut-outs |
Primary outcome
Operator dose
Time frame: Duration of coronary angiography of individuel patient, varies between approximately 5 minutes of radiation (easy access, exclusion coronary heart disease) and app. 3 hours (difficult and complex percutaneous coronary intervention).
Dose of radiation measured
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 20 Oct 2020.
- Derived from this study: PubMed 32338611Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial. EuroIntervention. 2020 Oct 23;16(8):663-671. doi: 10.4244/EIJ-D-19-00945.
- Derived from this study: PubMed 31272982Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial. BMJ Open. 2019 Jul 3;9(7):e029509. doi: 10.1136/bmjopen-2019-029509.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plain X-ray protection shield, Protection shield & X-ray protective strips and Protection shield & protective strips & patient cut-outs in people with Exposure of Member of Staff to Medical Diagnostic X-Ray, run by Tommaso Gori at 1 site in Germany.
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 1 inclusion and 1 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 20 Oct 2020. 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 Germany. 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?
Operator dose (time frame: Duration of coronary angiography of individuel patient, varies between approximately 5 minutes of radiation (easy access, exclusion coronary heart disease) and app. 3 hours (difficult and complex percutaneous coronary intervention).). 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 NCT03634657, which also lists 2 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 20 Oct 2020.