EmergenciesLESSNCT06189131
The Use of Ventriject to Assess V02Max in Patients Admitted to Hospital in the Emergency Surgery Setting
A study testing Ventriject in people with Emergencies and Surgery, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess whether Ventriject V02Max can provide values in a clinical setting and whether this value correlates with clinical outcome in patients admitted to the emergency general surgery department in a single centre. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Surgery
- What is being tested?
- Ventriject
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2023to 11 Nov 2025
- 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
- Adults (>18 years of age)
- Admitted under the General Surgery team within the last 24- 48 hours
- Anticipated hospital stay of a minimum of 48 hours
Who cannot join
- Patients who are unable to consent for participation in the study for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess whether Ventriject V02Max can provide values in a clinical setting and whether this value correlates with clinical outcome in patients admitted to the emergency general surgery department in a single centre. We will also be assessing the acceptability of the device to patients and clinicians.
Read the detailed description
Pre-operative risk stratification is an important aspect of clinical decision-making in patients undergoing surgery. Thorough pre-operative assessment aids in the evaluation of mortality and morbidity on an individual basis and enhances the process of shared decision-making. This is particularly important in emergency surgery, which is associated with higher morbidity and mortality than elective surgery. Emergency general surgery accounts for approximately 11% of surgical cases but represents 47% of all surgical related deaths and 28% of complications. Colorectal cancer surgery has demonstrated a 90-day mortality rate of 3.2% (NBOCA 2017) and is associated with complication rates of up to 30% (Luca et al 2014). In the emergency setting, the 90-day mortality after bowel cancer surgery rises to 8.7% (NBOCA 2021).
Cardiorespiratory fitness (CRF) is an independent risk factor for mortality and morbidity for individuals undergoing surgery (Older et al, Wilson et al). Cardiorespiratory complications are the leading cause of death in non-cardiac surgery (Devereaux et al 2015, Gupta et al 2011). The insult of surgery can cause a 40% reduction in CRF for individuals with a hospital stay of up to 9 days and only half of patients regain their CRF after 6 months (Jensen et al 2011).
Cardiopulmonary exercise testing (CPET) is an exercise stress test used before planned surgery to aid risk stratification of individual patients. The CPET test involves a treadmill exercise or cycle ergometry to assess anaerobic threshold (AT) and the peak oxygen uptake (V02 peak) (Older et al 2017. CPET is a method of quantifying CRF. CPET testing is limited in certain patient populations, such as those with a physical disability or arthritis. It is time-consuming, taking approximately 40-60 minutes per assessment. A survey of patients' experiences of CPET testing was conducted by Boyd in 2016. Several aspects of CPET were described as a "serious problem" and these included dryness in mouth (11%), muscle soreness (10%), being uncomfortable (8-9%) and coughing (9%). Generally, patients requiring emergency surgery will be too unwell to preform CPET testing, but also the combination of access to facilities and the time constraints of emergency surgery make CPET testing in an emergency scenario inappropriate.
Currently there are several scoring tools used to assess a patient's risk of surgery in the emergency setting, which include PPOSSUM and NELA. These scoring tools aid in the risk stratification of mortality and morbidity to aid in the decision making for clinicians and patients. Patient characteristics integrated in these scoring tools include evidence of cardiorespiratory dysfunction assessed on ECG and clinical evidence, blood pressure, heart rate and blood test results. However, there currently is no established method of measuring CRF in the emergency setting.
Ventriject is a non-exercise method for estimating V02Max. V02Max is defined as the metabolic rate at which oxygen uptake plateaus despite further increases in work rate and this maximum end point is rarely reached during CPET examinations. V02Max has been shown to relate to post operative outcomes (Scholes et al 2009).
Ventriject uses seismocardiography (SCG) signals generated by the vibrations from a beating heart, picked up by a small accelerometer placed on the chest. SCG is an alternative method of assessing cardiac function (Sorensen et al). V02Max is estimated from the SCG signal and patient demographics including gender, age, height and weight, using machine learning. Ventriject has been tested against CEPT in over 400 healthy subjects and has been found to closely correlate with V02Max measurements (0.80, p<0.001). This is the closest correlation to ergometer testing when compared to alternative methods.
It is estimated that each Ventriject assessment costs approximately £15 and takes a total of 120 seconds to complete. It requires no physical exercise and may be more acceptable in certain clinical situations and patient groups. Currently, Ventriject has been used in non-clinical settings and lacks evidence as to its usability in the clinical environment. Given the advantages of a cheap, rapid, and accessible method of measuring V02Max, Ventriject would be an appropriate method for measuring CRF in the emergency setting and may compliment the current risk stratification tools to aid in the clinical decision making around emergency surgery.
The aim of this study is to assess whether Ventriject V02Max can provide values in a clinical setting and whether this value correlates with clinical outcome in patients admitted to the emergency general surgery department in a single centre. We will also be assessing the acceptability of the device to patients and clinicians.
- Conditions
- Emergencies, Surgery
- Being tested
- Ventriject
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentrijectDevice
Ventriject is a non-exercise method for estimating V02Max
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Acutely admitted surgical patients with no planned surgery | Experimental | This cohort of individuals will be those admitted to the EGS department with a surgical pathology but who have not undergone surgery during the admission and by the end of data collection (7 days) (e.g. pancreatitis, conservative management intra-abdominal pathology). The rationale behind recruiting this cohort of patients is to assess the admission V02Max and how unwell patients are during their admission by correlating this result to their NEWS score, blood results and any evidence of clinical deterioration. This cohort of patients will help us understand whether V02Max correlates with patient's clinical conditions and outcomes. Receives: Device: Ventriject |
| Group 2: Acutely admitted surgical patients who have undergone an emergency procedure | Experimental | Pre and post-operative Ventriject V02Max values will be taken in this group of patients to assess whether pre-operative V02Max correlates with pre-operative PPOSSUM, NELA scores and post-operative outcomes. This group of participants will answer whether acute V02Max is reflective of operative outcomes and whether it correlates with current methods of risk stratification (PPOSSUM, NELA, ASA) and post-operative outcome scores (Clavien-Dindo classification). This group is important as it will help establish whether V02Max measurements in the acute setting for operative risk stratification is feasible. Receives: Device: Ventriject |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability for Ventriject to detect a V02Max value in individual patients
VO2 Max
Measured: 7 days
Secondary outcomes (3)
The acceptability of the device to patients
The acceptability of the device to patients
Measured: 7 days
The correlation between V02Max with the patients NEWS score, blood results, clinical deterioration & ASA grade. Group 2: The above in addition, PPOSSUM score, NELA score, Clavien Dindo Classification
The correlation between V02Max with the patient clinical conditions and outcomes
Measured: 7 days
The correlation between V02Max with the patients NEWS score, blood results, clinical deterioration, ASA grade, PPOSSUM score, NELA score & Clavien Dindo Classification
The correlation between V02Max with the patient clinical conditions and outcomes
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start3 Nov 2023
- Primary completion11 Nov 2025 (estimated)
- Study completion11 Nov 2025 (estimated)
Why it stopped: More funding required
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 EmergenciesStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be divided into two groups and allocation to the relevant group is based on whether the patient has required a surgical intervention during the study period. This determines which outcomes are relevant and reflects two important groups of patients admitted to emergency general surgery. The allocation to each group is finalised following completion of the data collection as the decision for operative management or conservative manage of certain pathologies can change.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Bautista, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189131
- Sponsor's protocol ID
- GS23/155862
- Acronym
- LESS
- Status last verified
- Mar 2025
- First submitted
- 26 Sep 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lucas DJ, Pawlik TM. Quality improvement in gastrointestinal surgical oncology with American College of Surgeons National Surgical Quality Improvement Program. Surgery. 2014 Apr;155(4):593-601. doi: 10.1016/j.surg.2013.12.001. Epub 2013 Dec 14.
PubMed 24508118Jensen MB, Houborg KB, Norager CB, Henriksen MG, Laurberg S. Postoperative changes in fatigue, physical function and body composition: an analysis of the amalgamated data from five randomized trials on patients undergoing colorectal surgery. Colorectal Dis. 2011 May;13(5):588-93. doi: 10.1111/j.1463-1318.2010.02232.x.
PubMed 20148922Steffens D, Ismail H, Denehy L, Beckenkamp PR, Solomon M, Koh C, Bartyn J, Pillinger N. Preoperative Cardiopulmonary Exercise Test Associated with Postoperative Outcomes in Patients Undergoing Cancer Surgery: A Systematic Review and Meta-Analyses. Ann Surg Oncol. 2021 Nov;28(12):7120-7146. doi: 10.1245/s10434-021-10251-3. Epub 2021 Jun 8.
PubMed 34101066Scholes RL, Browning L, Sztendur EM, Denehy L. Duration of anaesthesia, type of surgery, respiratory co-morbidity, predicted VO2max and smoking predict postoperative pulmonary complications after upper abdominal surgery: an observational study. Aust J Physiother. 2009;55(3):191-8. doi: 10.1016/s0004-9514(09)70081-9.
PubMed 19681741Wilson RJ, Davies S, Yates D, Redman J, Stone M. Impaired functional capacity is associated with all-cause mortality after major elective intra-abdominal surgery. Br J Anaesth. 2010 Sep;105(3):297-303. doi: 10.1093/bja/aeq128. Epub 2010 Jun 23.
PubMed 20573634Older P, Smith R, Courtney P, Hone R. Preoperative evaluation of cardiac failure and ischemia in elderly patients by cardiopulmonary exercise testing. Chest. 1993 Sep;104(3):701-4. doi: 10.1378/chest.104.3.701.
PubMed 8365279Sorensen K, Schmidt SE, Jensen AS, Sogaard P, Struijk JJ. Definition of Fiducial Points in the Normal Seismocardiogram. Sci Rep. 2018 Oct 18;8(1):15455. doi: 10.1038/s41598-018-33675-6.
PubMed 30337579Devereaux PJ, Sessler DI. Cardiac Complications in Patients Undergoing Major Noncardiac Surgery. N Engl J Med. 2015 Dec 3;373(23):2258-69. doi: 10.1056/NEJMra1502824. No abstract available.
PubMed 26630144Gupta H, Gupta PK, Fang X, Miller WJ, Cemaj S, Forse RA, Morrow LE. Development and validation of a risk calculator predicting postoperative respiratory failure. Chest. 2011 Nov;140(5):1207-1215. doi: 10.1378/chest.11-0466. Epub 2011 Jul 14.
PubMed 21757571
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ventriject to Assess V02Max in Patients Admitted to Hospital in the Emergency Surgery Setting
- ClinicalTrials.gov ID
- NCT06189131
- Acronym / sponsor ID
- LESS / GS23/155862
- Conditions
- Emergencies, Surgery
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: More funding required
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 11 Nov 2025 (estimated)
- Study completion
- 11 Nov 2025 (estimated)
- First posted
- 3 Jan 2024 (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 aim of this study is to assess whether Ventriject V02Max can provide values in a clinical setting and whether this value correlates with clinical outcome in patients admitted to the emergency general surgery department in a single centre. We will also be assessing the acceptability of the device to patients and clinicians.
Detailed description
Pre-operative risk stratification is an important aspect of clinical decision-making in patients undergoing surgery. Thorough pre-operative assessment aids in the evaluation of mortality and morbidity on an individual basis and enhances the process of shared decision-making. This is particularly important in emergency surgery, which is associated with higher morbidity and mortality than elective surgery. Emergency general surgery accounts for approximately 11% of surgical cases but represents 47% of all surgical related deaths and 28% of complications. Colorectal cancer surgery has demonstrated a 90-day mortality rate of 3.2% (NBOCA 2017) and is associated with complication rates of up to 30% (Luca et al 2014). In the emergency setting, the 90-day mortality after bowel cancer surgery rises to 8.7% (NBOCA 2021).
Cardiorespiratory fitness (CRF) is an independent risk factor for mortality and morbidity for individuals undergoing surgery (Older et al, Wilson et al). Cardiorespiratory complications are the leading cause of death in non-cardiac surgery (Devereaux et al 2015, Gupta et al 2011). The insult of surgery can cause a 40% reduction in CRF for individuals with a hospital stay of up to 9 days and only half of patients regain their CRF after 6 months (Jensen et al 2011).
Cardiopulmonary exercise testing (CPET) is an exercise stress test used before planned surgery to aid risk stratification of individual patients. The CPET test involves a treadmill exercise or cycle ergometry to assess anaerobic threshold (AT) and the peak oxygen uptake (V02 peak) (Older et al 2017. CPET is a method of quantifying CRF. CPET testing is limited in certain patient populations, such as those with a physical disability or arthritis. It is time-consuming, taking approximately 40-60 minutes per assessment. A survey of patients' experiences of CPET testing was conducted by Boyd in 2016. Several aspects of CPET were described as a "serious problem" and these included dryness in mouth (11%), muscle soreness (10%), being uncomfortable (8-9%) and coughing (9%). Generally, patients requiring emergency surgery will be too unwell to preform CPET testing, but also the combination of access to facilities and the time constraints of emergency surgery make CPET testing in an emergency scenario inappropriate.
Currently there are several scoring tools used to assess a patient's risk of surgery in the emergency setting, which include PPOSSUM and NELA. These scoring tools aid in the risk stratification of mortality and morbidity to aid in the decision making for clinicians and patients. Patient characteristics integrated in these scoring tools include evidence of cardiorespiratory dysfunction assessed on ECG and clinical evidence, blood pressure, heart rate and blood test results. However, there currently is no established method of measuring CRF in the emergency setting.
Ventriject is a non-exercise method for estimating V02Max. V02Max is defined as the metabolic rate at which oxygen uptake plateaus despite further increases in work rate and this maximum end point is rarely reached during CPET examinations. V02Max has been shown to relate to post operative outcomes (Scholes et al 2009).
Ventriject uses seismocardiography (SCG) signals generated by the vibrations from a beating heart, picked up by a small accelerometer placed on the chest. SCG is an alternative method of assessing cardiac function (Sorensen et al). V02Max is estimated from the SCG signal and patient demographics including gender, age, height and weight, using machine learning. Ventriject has been tested against CEPT in over 400 healthy subjects and has been found to closely correlate with V02Max measurements (0.80, p<0.001). This is the closest correlation to ergometer testing when compared to alternative methods.
It is estimated that each Ventriject assessment costs approximately £15 and takes a total of 120 seconds to complete. It requires no physical exercise and may be more acceptable in certain clinical situations and patient groups. Currently, Ventriject has been used in non-clinical settings and lacks evidence as to its usability in the clinical environment. Given the advantages of a cheap, rapid, and accessible method of measuring V02Max, Ventriject would be an appropriate method for measuring CRF in the emergency setting and may compliment the current risk stratification tools to aid in the clinical decision making around emergency surgery.
The aim of this study is to assess whether Ventriject V02Max can provide values in a clinical setting and whether this value correlates with clinical outcome in patients admitted to the emergency general surgery department in a single centre. We will also be assessing the acceptability of the device to patients and clinicians.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants will be divided into two groups and allocation to the relevant group is based on whether the patient has required a surgical intervention during the study period. This determines which outcomes are relevant and reflects two important groups of patients admitted to emergency general surgery. The allocation to each group is finalised following completion of the data collection as the decision for operative management or conservative manage of certain pathologies can change.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Acutely admitted surgical patients with no planned surgery | Experimental | Device: VentrijectThis cohort of individuals will be those admitted to the EGS department with a surgical pathology but who have not undergone surgery during the admission and by the end of data collection (7 days) (e.g. pancreatitis, conservative management intra-abdominal pathology). The rationale behind recruiting this cohort of patients is to assess the admission V02Max and how unwell patients are during their admission by correlating this result to their NEWS score, blood results and any evidence of clinical deterioration. This cohort of patients will help us understand whether V02Max correlates with patient's clinical conditions and outcomes. |
| Group 2: Acutely admitted surgical patients who have undergone an emergency procedure | Experimental | Device: VentrijectPre and post-operative Ventriject V02Max values will be taken in this group of patients to assess whether pre-operative V02Max correlates with pre-operative PPOSSUM, NELA scores and post-operative outcomes. This group of participants will answer whether acute V02Max is reflective of operative outcomes and whether it correlates with current methods of risk stratification (PPOSSUM, NELA, ASA) and post-operative outcome scores (Clavien-Dindo classification). This group is important as it will help establish whether V02Max measurements in the acute setting for operative risk stratification is feasible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (>18 years of age)
- Admitted under the General Surgery team within the last 24- 48 hours
- Anticipated hospital stay of a minimum of 48 hours
Key exclusion criteria (1 listed)
- Patients who are unable to consent for participation in the study for any reason.
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 |
|---|---|---|
| VentrijectVentriject is a non-exercise method for estimating V02Max | Device | Group 1: Acutely admitted surgical patients with no planned surgery, Group 2: Acutely admitted surgical patients who have undergone an emergency procedure |
Primary outcome
The ability for Ventriject to detect a V02Max value in individual patients
Time frame: 7 days
VO2 Max
3 secondary outcomes
The acceptability of the device to patients
Time frame: 7 days
The correlation between V02Max with the patients NEWS score, blood results, clinical deterioration & ASA grade. Group 2: The above in addition, PPOSSUM score, NELA score, Clavien Dindo Classification
Time frame: 7 days
The correlation between V02Max with the patients NEWS score, blood results, clinical deterioration, ASA grade, PPOSSUM score, NELA score & Clavien Dindo Classification
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 24508118Lucas DJ, Pawlik TM. Quality improvement in gastrointestinal surgical oncology with American College of Surgeons National Surgical Quality Improvement Program. Surgery. 2014 Apr;155(4):593-601. doi: 10.1016/j.surg.2013.12.001. Epub 2013 Dec 14.
- Background: PubMed 20148922Jensen MB, Houborg KB, Norager CB, Henriksen MG, Laurberg S. Postoperative changes in fatigue, physical function and body composition: an analysis of the amalgamated data from five randomized trials on patients undergoing colorectal surgery. Colorectal Dis. 2011 May;13(5):588-93. doi: 10.1111/j.1463-1318.2010.02232.x.
- Background: PubMed 34101066Steffens D, Ismail H, Denehy L, Beckenkamp PR, Solomon M, Koh C, Bartyn J, Pillinger N. Preoperative Cardiopulmonary Exercise Test Associated with Postoperative Outcomes in Patients Undergoing Cancer Surgery: A Systematic Review and Meta-Analyses. Ann Surg Oncol. 2021 Nov;28(12):7120-7146. doi: 10.1245/s10434-021-10251-3. Epub 2021 Jun 8.
- Background: PubMed 19681741Scholes RL, Browning L, Sztendur EM, Denehy L. Duration of anaesthesia, type of surgery, respiratory co-morbidity, predicted VO2max and smoking predict postoperative pulmonary complications after upper abdominal surgery: an observational study. Aust J Physiother. 2009;55(3):191-8. doi: 10.1016/s0004-9514(09)70081-9.
- Background: PubMed 20573634Wilson RJ, Davies S, Yates D, Redman J, Stone M. Impaired functional capacity is associated with all-cause mortality after major elective intra-abdominal surgery. Br J Anaesth. 2010 Sep;105(3):297-303. doi: 10.1093/bja/aeq128. Epub 2010 Jun 23.
- Background: PubMed 8365279Older P, Smith R, Courtney P, Hone R. Preoperative evaluation of cardiac failure and ischemia in elderly patients by cardiopulmonary exercise testing. Chest. 1993 Sep;104(3):701-4. doi: 10.1378/chest.104.3.701.
- Background: PubMed 30337579Sorensen K, Schmidt SE, Jensen AS, Sogaard P, Struijk JJ. Definition of Fiducial Points in the Normal Seismocardiogram. Sci Rep. 2018 Oct 18;8(1):15455. doi: 10.1038/s41598-018-33675-6.
- Background: PubMed 26630144Devereaux PJ, Sessler DI. Cardiac Complications in Patients Undergoing Major Noncardiac Surgery. N Engl J Med. 2015 Dec 3;373(23):2258-69. doi: 10.1056/NEJMra1502824. No abstract available.
- Background: PubMed 21757571Gupta H, Gupta PK, Fang X, Miller WJ, Cemaj S, Forse RA, Morrow LE. Development and validation of a risk calculator predicting postoperative respiratory failure. Chest. 2011 Nov;140(5):1207-1215. doi: 10.1378/chest.11-0466. Epub 2011 Jul 14.
- national-bowel-cancer-audit-annual-report-2017Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Melissa Bautista principal investigator
Leeds Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventriject in people with Emergencies and Surgery, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 3 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: paused, as of the sponsor's last update on 19 Mar 2025. 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 Kingdom. 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?
Results are not available in the source record.
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?
The ability for Ventriject to detect a V02Max value in individual patients (time frame: 7 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 NCT06189131, 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 19 Mar 2025.