SepsisMINI3NCT04934943
"Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools"
An observational study of Sepsis and Shock, Septic, run by Humanitas Clinical and Research Center at 2 sites in Italy.
Trial summary
The mini fluid challenge (mini_FC) is a functional hemodynamic test which has been used in different clinical contexts to assess fluid responsiveness. This test is performed by rapidly injecting a small aliquot of fluid (100 ml over 1 minute), which is followed by the infusion of the residual aliquot of fluid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Shock, Septic, Critically Ill
- What is being tested?
- mini_FC
- How many people
- 45 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Aug 2025to 1 Aug 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adults critically ill patients with acute circulatory failure, who require volume expansion decided by the clinician in charge.
Who may be able to join
- 1) Acute circulatory failure defined as:
- SAP ≤ 90 mmHg (or a decrease > 50 mm Hg in hypertensive patients)
- or a mean arterial pressure (MAP) ≤ 70 mmHg
- or the use of vasopressors to maintain SAP >90 mmHg,
- associated with skin mottling; tachycardia ≥100 beats/min; urinary flow ≤0.5 mL/kg for at least 2 hours; blood lactate level ≥4 mmol/L.
Who cannot join
- known severe myocardial or valvular dysfunction
- cardiac arrhythmias
- severe acute respiratory distress syndrome
- on-going haemodialysis or continuous hemofiltration
- moribund patients
- persistent low quality of the arterial signal affecting hemodynamic monitoring measurements
- poor echographic windows.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
Antonio Messina
Novara, Novara, 28100
Humanitas Research Hospital
Rozzano, MILANO, 20089
Antonio Messina, MD, +390282241, antonio.messina@humanitas.it
Antonio Messina, MD, +3902822414131, mess81rc@gmail.com
About this study
The mini fluid challenge (mini_FC) is a functional hemodynamic test which has been used in different clinical contexts to assess fluid responsiveness.
This test is performed by rapidly injecting a small aliquot of fluid (100 ml over 1 minute), which is followed by the infusion of the residual aliquot of fluid.
Read more
Since the threshold of the mini_FC identified by the literature is rather small (5% of stroke volume (SV) increase after the 100 ml bolus to discriminate between responder and non-responder), it is crucial that the hemodynamic tool assessing this change could be reliable. Moreover, the SV changes with inspiratory/expiratory movements and the increase after the mini_FC should also consider the physiological fluctuations of the SV.
In the literature this test has been performed by means of tolls with different least significant change of the SV. The least significant change (LSC) represents the smallest difference between successive measurements of SV that can be considered to be a real change and not attributable to chance.
The purpose of this study is to assess the agreement among MOSTCARE system (4.5\& of SV LSC described in the literature) and the echocardiography (about 10% of SV LSC described in the literature) with the PICCO system (about 1% of SV LSC described in the literature - considered the gold standard) in discriminating fluid responsiveness after a mini_FC
Read the detailed description
Targeted fluid therapy has received increasing attention in the management of patients showing acute circulatory failure in both intensive care unit (ICU) and operating room (OR), aiming at preventing both inadequate tissue blood flow and fluid overload. In fact, unnecessary fluid administration can increase morbidity and mortality and length of hospital stay of critically ill and surgical patients.
Since the only physiological reason to give a fluid challenge (FC) is to increase the stroke volume (SV) and this effect is obtained only in about 50% of ICU and OR patients, a vast literature investigated the possibility of predict this effect before FC administration, but the issue remains extremely challenging. Bedside clinical signs and pressure and static volumetric static variables, do not predict fluid responsiveness. Moreover, several physiological factors affect the reliability of the ventilator-induced dynamic changes in pulse pressure and stroke volume [pulse pressure variation (PPV) and stroke volume (SV) variation (SVV), respectively], and their echographic surrogates, in a significant number of ICU and OR patients.
To overcome these limitations, the functional hemodynamic assessment (i.e. the assessment of the dynamic interactions of hemodynamic variables in response to a defined perturbation), of fluid responsiveness has gained in popularity. A functional hemodynamic test (FHT) consist in a manoeuvre determining a sudden change in cardiac function and/or heart lung interaction, affecting the hemodynamics of fluid responders and non-responders to a different extent.
The FHT called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 and its reliability has been confirmed by three large meta-analyses. However, the PLR is not usually practicable in the OR.
A lot of different FHTs have been proposed, as alternative to the PLR, in ICU and, more recently, OR. These tests could be basically subdivided in two groups. A subgroup of FHTs is based on sudden and brief variations of the mechanical ventilation to induce a change in right ventricle preload and/or after load and, as consequence, of left ventricle. Among these tests, the rapid administration of a small aliquot of the predefined FC (the so-called mini FC) has gained in popularity in the last years.
On of the drawbacks of this test is that the optimal threshold identified in the literature to stratify responders and non-responders (5% of SV variation) is quite small, and potentially affected by the reliability of the hemodynamic tool used. The aim of this paper is to compare the reliability of a hemodynamic invasive tool (the (PiCCO2 TM, Pulsion Medical Systems, Munich, Germany - considered the gold standard) with a mini-invasive tool (MostCareTM system (Vytech Health, Padua, Italy) and a non-invasive (echocardiography) in predicting the response to the mini-FC in critically ill patients.
- Conditions
- Sepsis, Shock, Septic, Critically Ill
- Being tested
- mini_FC
- Keywords
- Fluid challenge, Functional hemodynamic test
- Medical subject headings
- Sepsis, Shock, Septic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini_FCDiagnostic test
100 ml of Crystalloids infused over 1 minute - data recording and new baseline - FC 4 ml/kg in 10 minutes - data recording
| Study group | Role | What they receive |
|---|---|---|
| Intervention _mini_FC | The fluid challenge consists of 4 ml*Kg of Crystalloids' solution infused over 10 minutes, administered via either a central or a peripheral line.
1. The patient is already connected to the PICCO monitoring for clinical purpose of hemodynamic monitoring (before study enrollment)
2. The MOSTCARE system is connected to the MONITOR of the patient (and not to the patient itself) by means of a cable inserted into the connections system.
3. The echocardiography will be performed by a senior intensivist/cardiologist. The stroke volume is calculated by measuring VTI and diameter at the same point. This is best performed by measuring the diameter of the LVOT in the parasternal long axis (PLAX) view Receives: Diagnostic Test: mini_FC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of allocation
Number of responders and non-responders identified by the MOSTCARE and the Echocardiography with respect to the PICCO system (considered as gold standard)
Measured: immediately after the procedure
Secondary outcomes (8)
Least significant change of the stroke volume - PICCO
off-line analysis of the recorded stroke volume change before the test
Measured: 5 minutes before FC administration
Least significant change of the stroke volume - MOSTCARE
off-line analysis of the recorded stroke volume change before the test
Measured: 5 minutes before FC administration
Least significant change of the stroke volume - Echocardiography
off-line analysis of the recorded stroke volume change before the test
Measured: 5 minutes before FC administration
ROC curve - PICCO
ROC curve analysis of stroke volume changes after mini fluid challenge infusion
Measured: 1 minute after mini fluid challenge infusion
ROC curve - MOSTCARE
ROC curve analysis of stroke volume changes after mini fluid challenge infusion
Measured: 1 minute after mini fluid challenge infusion
ROC curve - Echocardiograhy
ROC curve analysis of stroke volume changes after mini fluid challenge infusion
Measured: 1 minute after mini fluid challenge infusion
Agreement stroke volume estimation - MOSTCARE versus PICCO
Agreements between stroke volume data are determined using the Bland-Altman method, with the bias calculated as the mean difference between methods and reflecting the measurement error between the two tests.
Measured: immediately after the procedure
Agreement stroke volume estimation - Echocardiography versus PICCO
Agreements between stroke volume data are determined using the Bland-Altman method, with the bias calculated as the mean difference between methods and reflecting the measurement error between the two tests.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934943
- Sponsor's protocol ID
- MINI3
- Acronym
- MINI3
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2021
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Messina A, Lionetti G, Foti L, Bellotti E, Marcomini N, Cammarota G, Bennett V, Saderi L, Sotgiu G, Della Corte F, Protti A, Monge Garcia MI, Romagnoli S, Cecconi M. Mini fluid chAllenge aNd End-expiratory occlusion test to assess flUid responsiVEness in the opeRating room (MANEUVER study): A multicentre cohort study. Eur J Anaesthesiol. 2021 Apr 1;38(4):422-431. doi: 10.1097/EJA.0000000000001406.
PubMed 33399372de Courson H, Ferrer L, Cane G, Verchere E, Sesay M, Nouette-Gaulain K, Biais M. Evaluation of least significant changes of pulse contour analysis-derived parameters. Ann Intensive Care. 2019 Oct 11;9(1):116. doi: 10.1186/s13613-019-0590-z.
PubMed 31602550Georges D, de Courson H, Lanchon R, Sesay M, Nouette-Gaulain K, Biais M. End-expiratory occlusion maneuver to predict fluid responsiveness in the intensive care unit: an echocardiographic study. Crit Care. 2018 Feb 8;22(1):32. doi: 10.1186/s13054-017-1938-0.
PubMed 29415773Messina A, Dell'Anna A, Baggiani M, Torrini F, Maresca GM, Bennett V, Saderi L, Sotgiu G, Antonelli M, Cecconi M. Functional hemodynamic tests: a systematic review and a metanalysis on the reliability of the end-expiratory occlusion test and of the mini-fluid challenge in predicting fluid responsiveness. Crit Care. 2019 Jul 29;23(1):264. doi: 10.1186/s13054-019-2545-z.
PubMed 31358025Shi R, Monnet X, Teboul JL. Parameters of fluid responsiveness. Curr Opin Crit Care. 2020 Jun;26(3):319-326. doi: 10.1097/MCC.0000000000000723.
PubMed 32332283Vistisen ST, Scheeren TWL. Challenge of the Mini-fluid Challenge: Filling Twice without Creating a Self-fulfilling Prophecy Design. Anesthesiology. 2018 May;128(5):1043-1044. doi: 10.1097/ALN.0000000000002141. No abstract available.
PubMed 29664782Biais M, de Courson H, Lanchon R, Pereira B, Bardonneau G, Griton M, Sesay M, Nouette-Gaulain K. Mini-fluid Challenge of 100 ml of Crystalloid Predicts Fluid Responsiveness in the Operating Room. Anesthesiology. 2017 Sep;127(3):450-456. doi: 10.1097/ALN.0000000000001753.
PubMed 28640019
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools"
- ClinicalTrials.gov ID
- NCT04934943
- Acronym / sponsor ID
- MINI3 / MINI3
- Conditions
- Sepsis, Shock, Septic, Critically Ill
- Keywords
- Fluid challenge, Functional hemodynamic test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 22 Jun 2021 (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.
The mini fluid challenge (mini_FC) is a functional hemodynamic test which has been used in different clinical contexts to assess fluid responsiveness.
This test is performed by rapidly injecting a small aliquot of fluid (100 ml over 1 minute), which is followed by the infusion of the residual aliquot of fluid.
Since the threshold of the mini_FC identified by the literature is rather small (5% of stroke volume (SV) increase after the 100 ml bolus to discriminate between responder and non-responder), it is crucial that the hemodynamic tool assessing this change could be reliable. Moreover, the SV changes with inspiratory/expiratory movements and the increase after the mini_FC should also consider the physiological fluctuations of the SV.
In the literature this test has been performed by means of tolls with different least significant change of the SV. The least significant change (LSC) represents the smallest difference between successive measurements of SV that can be considered to be a real change and not attributable to chance.
The purpose of this study is to assess the agreement among MOSTCARE system (4.5\& of SV LSC described in the literature) and the echocardiography (about 10% of SV LSC described in the literature) with the PICCO system (about 1% of SV LSC described in the literature - considered the gold standard) in discriminating fluid responsiveness after a mini_FC
Detailed description
Targeted fluid therapy has received increasing attention in the management of patients showing acute circulatory failure in both intensive care unit (ICU) and operating room (OR), aiming at preventing both inadequate tissue blood flow and fluid overload. In fact, unnecessary fluid administration can increase morbidity and mortality and length of hospital stay of critically ill and surgical patients.
Since the only physiological reason to give a fluid challenge (FC) is to increase the stroke volume (SV) and this effect is obtained only in about 50% of ICU and OR patients, a vast literature investigated the possibility of predict this effect before FC administration, but the issue remains extremely challenging. Bedside clinical signs and pressure and static volumetric static variables, do not predict fluid responsiveness. Moreover, several physiological factors affect the reliability of the ventilator-induced dynamic changes in pulse pressure and stroke volume [pulse pressure variation (PPV) and stroke volume (SV) variation (SVV), respectively], and their echographic surrogates, in a significant number of ICU and OR patients.
To overcome these limitations, the functional hemodynamic assessment (i.e. the assessment of the dynamic interactions of hemodynamic variables in response to a defined perturbation), of fluid responsiveness has gained in popularity. A functional hemodynamic test (FHT) consist in a manoeuvre determining a sudden change in cardiac function and/or heart lung interaction, affecting the hemodynamics of fluid responders and non-responders to a different extent.
The FHT called passive leg raising (PLR) has been successfully used for assessing the fluid responsiveness in ICU patients since 2009 and its reliability has been confirmed by three large meta-analyses. However, the PLR is not usually practicable in the OR.
A lot of different FHTs have been proposed, as alternative to the PLR, in ICU and, more recently, OR. These tests could be basically subdivided in two groups. A subgroup of FHTs is based on sudden and brief variations of the mechanical ventilation to induce a change in right ventricle preload and/or after load and, as consequence, of left ventricle. Among these tests, the rapid administration of a small aliquot of the predefined FC (the so-called mini FC) has gained in popularity in the last years.
On of the drawbacks of this test is that the optimal threshold identified in the literature to stratify responders and non-responders (5% of SV variation) is quite small, and potentially affected by the reliability of the hemodynamic tool used. The aim of this paper is to compare the reliability of a hemodynamic invasive tool (the (PiCCO2 TM, Pulsion Medical Systems, Munich, Germany - considered the gold standard) with a mini-invasive tool (MostCareTM system (Vytech Health, Padua, Italy) and a non-invasive (echocardiography) in predicting the response to the mini-FC in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention _mini_FC | – | Diagnostic Test: mini_FCThe fluid challenge consists of 4 ml*Kg of Crystalloids' solution infused over 10 minutes, administered via either a central or a peripheral line. 1. The patient is already connected to the PICCO monitoring for clinical purpose of hemodynamic monitoring (before study enrollment) 2. The MOSTCARE system is connected to the MONITOR of the patient (and not to the patient itself) by means of a cable inserted into the connections system. 3. The echocardiography will be performed by a senior intensivist/cardiologist. The stroke volume is calculated by measuring VTI and diameter at the same point. This is best performed by measuring the diameter of the LVOT in the parasternal long axis (PLAX) view |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults critically ill patients with acute circulatory failure, who require volume expansion decided by the clinician in charge.
Key inclusion criteria (5 listed)
- SAP ≤ 90 mmHg (or a decrease > 50 mm Hg in hypertensive patients)
- or a mean arterial pressure (MAP) ≤ 70 mmHg
- or the use of vasopressors to maintain SAP >90 mmHg,
- associated with skin mottling; tachycardia ≥100 beats/min; urinary flow ≤0.5 mL/kg for at least 2 hours; blood lactate level ≥4 mmol/L.
Key exclusion criteria (7 listed)
- known severe myocardial or valvular dysfunction
- cardiac arrhythmias
- severe acute respiratory distress syndrome
- on-going haemodialysis or continuous hemofiltration
- moribund patients
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 |
|---|---|---|
| mini_FC100 ml of Crystalloids infused over 1 minute - data recording and new baseline - FC 4 ml/kg in 10 minutes - data recording | Diagnostic test | Intervention _mini_FC |
Primary outcome
Agreement of allocation
Time frame: immediately after the procedure
Number of responders and non-responders identified by the MOSTCARE and the Echocardiography with respect to the PICCO system (considered as gold standard)
8 secondary outcomes
Least significant change of the stroke volume - PICCO
Time frame: 5 minutes before FC administration
Least significant change of the stroke volume - MOSTCARE
Time frame: 5 minutes before FC administration
Least significant change of the stroke volume - Echocardiography
Time frame: 5 minutes before FC administration
ROC curve - PICCO
Time frame: 1 minute after mini fluid challenge infusion
ROC curve - MOSTCARE
Time frame: 1 minute after mini fluid challenge infusion
ROC curve - Echocardiograhy
Time frame: 1 minute after mini fluid challenge infusion
Agreement stroke volume estimation - MOSTCARE versus PICCO
Time frame: immediately after the procedure
Agreement stroke volume estimation - Echocardiography versus PICCO
Time frame: immediately after the procedure
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 29 Jun 2025.
- Background: PubMed 33399372Messina A, Lionetti G, Foti L, Bellotti E, Marcomini N, Cammarota G, Bennett V, Saderi L, Sotgiu G, Della Corte F, Protti A, Monge Garcia MI, Romagnoli S, Cecconi M. Mini fluid chAllenge aNd End-expiratory occlusion test to assess flUid responsiVEness in the opeRating room (MANEUVER study): A multicentre cohort study. Eur J Anaesthesiol. 2021 Apr 1;38(4):422-431. doi: 10.1097/EJA.0000000000001406.
- Background: PubMed 31602550de Courson H, Ferrer L, Cane G, Verchere E, Sesay M, Nouette-Gaulain K, Biais M. Evaluation of least significant changes of pulse contour analysis-derived parameters. Ann Intensive Care. 2019 Oct 11;9(1):116. doi: 10.1186/s13613-019-0590-z.
- Background: PubMed 29415773Georges D, de Courson H, Lanchon R, Sesay M, Nouette-Gaulain K, Biais M. End-expiratory occlusion maneuver to predict fluid responsiveness in the intensive care unit: an echocardiographic study. Crit Care. 2018 Feb 8;22(1):32. doi: 10.1186/s13054-017-1938-0.
- Background: PubMed 31358025Messina A, Dell'Anna A, Baggiani M, Torrini F, Maresca GM, Bennett V, Saderi L, Sotgiu G, Antonelli M, Cecconi M. Functional hemodynamic tests: a systematic review and a metanalysis on the reliability of the end-expiratory occlusion test and of the mini-fluid challenge in predicting fluid responsiveness. Crit Care. 2019 Jul 29;23(1):264. doi: 10.1186/s13054-019-2545-z.
- Background: PubMed 32332283Shi R, Monnet X, Teboul JL. Parameters of fluid responsiveness. Curr Opin Crit Care. 2020 Jun;26(3):319-326. doi: 10.1097/MCC.0000000000000723.
- Background: PubMed 29664782Vistisen ST, Scheeren TWL. Challenge of the Mini-fluid Challenge: Filling Twice without Creating a Self-fulfilling Prophecy Design. Anesthesiology. 2018 May;128(5):1043-1044. doi: 10.1097/ALN.0000000000002141. No abstract available.
- Background: PubMed 28640019Biais M, de Courson H, Lanchon R, Pereira B, Bardonneau G, Griton M, Sesay M, Nouette-Gaulain K. Mini-fluid Challenge of 100 ml of Crystalloid Predicts Fluid Responsiveness in the Operating Room. Anesthesiology. 2017 Sep;127(3):450-456. doi: 10.1097/ALN.0000000000001753.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Related trials for Sepsis
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Shock, Septic, run by Humanitas Clinical and Research Center at 2 sites in Italy.
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 5 inclusion and 7 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of allocation (time frame: immediately after the procedure). 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 NCT04934943, which also lists 7 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 29 Jun 2025.