Surgery-ComplicationsNCT06042491
The STRIVE Before Surgery Pilot Trial
A study testing Prehabilitation intervention in people with Surgery-Complications and Disability Physical, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The STRIVE Before Surgery Trial evaluates three pragmatic elements (recruitment, adherence, and follow-up) associated with participating in a home-based multimodal prehabilitation program supported through an online platform. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery-Complications, Disability Physical
- What is being tested?
- Prehabilitation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2024to 19 Jan 2026
- 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
- Age ≥18 years
- Scheduled, or on the pathway, for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery
- Expected surgery date between 3 and 12 weeks from enrollment
- Valid provincial health insurance number
- Access to internet-enabled device
- Email address
Who cannot join
- Inability to read and communicate in English
- Cognitive impairment preventing ability to provide informed consent independently
- No telephone/cell phone
- Cardiac, neurological or orthopedic procedure
- Surgery with no curative intent (palliative surgery)
- Patient not interested in participating in the context of their Telephone Assessment of Physical Activity (TAPA) score
Show all 10Show fewer
- Any of the following cardiovascular conditions:
- Severe valvular heart disease that limits a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
- Severe cardiac dysrhythmias that limit a patient's ability to ambulate on level ground, or is associated with syncope or dyspnea
- Recent myocardial infarction (within 6 weeks prior to enrollment - based on the Heart and Stroke Foundation's Heart Walk program)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The STRIVE Before Surgery Pilot Trial: a Vanguard Pragmatic Multicenter Randomized Trial of Structured TRaining to Improve Fitness in a Virtual Environment (STRIVE) Before Surgery
The STRIVE Before Surgery Trial evaluates three pragmatic elements (recruitment, adherence, and follow-up) associated with participating in a home-based multimodal prehabilitation program supported through an online platform. Half of the participants will be randomized into the prehabilitation group, while the other half will be randomized into the control group.
Read the detailed description
Background: The number of people presenting for surgery, and their risk profile, are increasing. People presenting for surgery face substantial risk of postoperative adverse events. Fifteen to 30% of patients suffer a serious medical or surgical complication after surgery, and 1 in 5 develop a new patient-reported disability that reflects a loss of independence in day-to-day life. More than 1.4 million inpatient surgical procedures are performed in Canada each year. Globally, >300 million surgical procedures occur annually. As an increasing number of people present for surgery, the average risk profile of this population is rising. Surgical patients are typically older and live with comorbidity. This means that strategies to improve patient outcomes and reduce resource utilization are urgently needed. Patients, the public, clinicians, and policy makers participating in 2 separate James Lind Alliance Priority Setting Partnerships (Canada \& UK) identified prehabilitation as a Top 10 priority for perioperative research. Furthermore, prehabilitation is currently discussed in the popular media as a strategy to improve outcomes for the growing number of high-risk patients presenting for surgery.
Overarching Aim: The STRIVE Before Surgery Trial will evaluate three pragmatic elements (recruitment, adherence, and follow-up) that our experience in prehabilitation research demonstrate are necessary to support successful, large-scale evaluation. The investigators will concurrently use implementation science methodology to further refine processes for the larger trial. As this is a vanguard pilot trial, data from this trial will be combined with the future, large-scale trial.
Methods:
Design, setting and participants: The STRIVE Before Surgery Trial is an assessor blinded multicenter individual patient parallel-arm vanguard pragmatic randomized controlled trial.
People => 18 years old having inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery with expected length of stay of => 2 days will be included.
Intervention: The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.
Outcomes and sample size: Primary outcomes are monthly recruitment, intervention adherence, retention, and elicitation of patient, clinician and researcher-identified barriers. Secondary outcomes are days at home in the 30 days after surgery, survival, length of stay, patient safety indicators, intensive care unit admission, non-home discharge, readmission, emergency department visits, and health system costs. Our vanguard trial sample size estimate is informed by a power calculation for the future large-scale trial. For the vanguard trial, a sample size of 144 directly links to our 3 feasibility outcomes: 1) recruitment of 144 participants over 8-10 months at our 5 sites will demonstrate our ability to average 2-4 participants per site per month. To continue the momentum of the trial, the pilot sample size can increase up to a maximum of 190 participants, providing time for the research team to seamlessly launch the full-scale trial. The pilot phase will merge into the full-scale trial. Having flexibility in the pilot sample size will support this process.
Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.
Expected outcomes: Knowledge gained from our vanguard trial will directly inform the larger pragmatic trial, which will be powered to detect a minimally important difference in a patient-reported outcome.
- Conditions
- Surgery-Complications, Disability Physical
- Being tested
- Prehabilitation intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation interventionBehavioural
The intervention consists of exercise, nutritional support and breathing techniques. The exercise component consists of 1) strength training; 2) cardio and 3) stretching. Participants will be encouraged to complete self-directed and/or group sessions >= 3 times per week. Each intervention participant will be provided a unique login to the virtual prehabilitation platform, which is the STRIVE Trial website. The nutrition component includes: 1) protein supplementation; 2) nutrition advice to support healthy eating. For the breathing component, participants will be encouraged to watch the video on Inspiratory Muscle Training (IMT) which involves diaphragmatic breathing and coughing/huffing. They will also be provided with an instruction booklet to take to hospital with them to support postoperative conduct of IMT during early recovery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform. Receives: Behavioral: Prehabilitation intervention |
| Control | No intervention | To support blinding, improve enrollment and reflect usual care, widely available physical activity (World Health Organization Recommendations for Physical Activity for ages 18-64 and >65) and healthy eating recommendations (Canada's Food Guide Snapshot) documents will be provided to control participants (without active or online support). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly recruitment
Recruited patients per center per month will be analyzed descriptively to generate a mean and standard deviation. Recruitment feasibility will be judged based on criteria pre-established that consider the number of available, committed sites in Ontario.
Measured: 1 year
Intervention adherence
The proportion of prescribed prehabilitation tasks adhered to
Measured: pre-surgery
Retention
The proportion of participants retained at 30-day patient-reported follow up will be calculated with a 95% confidence interval based on Wilson's method.
Measured: 1 month, year 1
Elicitation of patient, clinician and researcher-identified barriers
For each target group, the frequency of domains identified as barriers will be calculated.
Measured: 1 year
Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) (to be merged with larger trial)
The WHODAS is a patient-reported disability scale that assesses limitations in six major life domains (i.e., cognition, mobility, self-care, social interaction, life activities, participation in society). Each questionnaire item is scored on a Likert scale ranging from 0 to 4. The sum of the responses is the WHODAS Disability Score (range: 0 to 48), which is expressed as a percentage of the maximum possible score
Measured: 1 month, 3 month, 1 year
Secondary outcomes (11)
Days at home (to be merged with larger trial)
A count of days at home in the 30-days after surgery is a validated patient-centered outcome that can be ascertained from routinely collected data
Measured: 1 month, 1 year
Survival (to be merged with larger trial)
All cause deaths and survival time in the 30-days and year after surgery will be captured from vital statistics
Measured: 1 year
Length of Stay (to be merged with larger trial)
Days from surgical admission to discharge
Measured: 1 year
Patient Safety Events (to be merged with larger trial)
A validated set of in-hospital patient safety indicators will be captured from the index hospitalization record
Measured: 1 year
Intensive care unit admission (to be merged with larger trial)
Intensive care unit admission captured by administrative data
Measured: 1 year
Non-home discharge (to be merged with larger trial)
Discharge from the index hospitalization via transfer to a non-home location or death
Measured: 1 year
Re-admission (to be merged with larger trial)
Number of re-admissions to hospital
Measured: 1 month, 1 year
Emergency department visits (to be merged with larger trial)
Number of emergency department visits
Measured: 1 month, 1 year
Health system costs (to be merged with larger trial)
A validated patient-level costing algorithm will be used to capture all health system costs accrued within 30-days and 1-year after surgery
Measured: 1 month, 1 year
Health Related Quality of Life using the EQ-5D-5L (to be merged with larger trial)
EQ-5D-5L will be used to capture health related quality of life at baseline, pre-op, 30, 90, and 365 days after surgery.
Measured: 1 month, 3 month, 1 year
In-hospital complications
Postoperative Morbidity Survey (POMS) is a tool used to used to identify complications. At time of discharge, participants will be administered a patient-reported version of the POMS tool
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start30 Jan 2024
- Primary completion4 Dec 2024
- Study completion19 Jan 2026
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 Surgery-ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Daniel McIsaac, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042491
- Sponsor's protocol ID
- CTO - 4479
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.
Publications
McIsaac DI, Hallet J, Kidd G, Lee S, Taljaard M, Tandon P, Wijeysundera DN, Gillis C; STRIVE Trial Investigator Group. Home-based, virtually supported multimodal prehabilitation compared with usual care prior to major surgery: a multicentre, pragmatic pilot randomised trial. BJA Open. 2026 Apr 16;18:100550. doi: 10.1016/j.bjao.2026.100550. eCollection 2026 Jun.
PubMed 42027625McIsaac DI, Tandon P, Kidd G, Branje K, Hladkowicz E, Hallet J, Wijeysundera DN, Lee S, McNeely ML, Taljaard M, Gillis C; STRIVE Trial Investigators; Canadian Perioperative Anesthesia Clinical Trials Group (PACT). STRIVE pilot trial: a protocol for a multicentre pragmatic internal pilot randomised controlled trial of Structured TRaining to Improve fitness in a Virtual Environment (STRIVE) before surgery. BMJ Open. 2024 Nov 7;14(11):e093710. doi: 10.1136/bmjopen-2024-093710.
PubMed 39510784
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STRIVE Before Surgery Pilot Trial: a Vanguard Pragmatic Multicenter Randomized Trial of Structured TRaining to Improve Fitness in a Virtual Environment (STRIVE) Before Surgery
- ClinicalTrials.gov ID
- NCT06042491
- Acronym / sponsor ID
- CTO - 4479
- Conditions
- Surgery-Complications, Disability Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 18 Sep 2023 (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 STRIVE Before Surgery Trial evaluates three pragmatic elements (recruitment, adherence, and follow-up) associated with participating in a home-based multimodal prehabilitation program supported through an online platform. Half of the participants will be randomized into the prehabilitation group, while the other half will be randomized into the control group.
Detailed description
Background: The number of people presenting for surgery, and their risk profile, are increasing. People presenting for surgery face substantial risk of postoperative adverse events. Fifteen to 30% of patients suffer a serious medical or surgical complication after surgery, and 1 in 5 develop a new patient-reported disability that reflects a loss of independence in day-to-day life. More than 1.4 million inpatient surgical procedures are performed in Canada each year. Globally, >300 million surgical procedures occur annually. As an increasing number of people present for surgery, the average risk profile of this population is rising. Surgical patients are typically older and live with comorbidity. This means that strategies to improve patient outcomes and reduce resource utilization are urgently needed. Patients, the public, clinicians, and policy makers participating in 2 separate James Lind Alliance Priority Setting Partnerships (Canada \& UK) identified prehabilitation as a Top 10 priority for perioperative research. Furthermore, prehabilitation is currently discussed in the popular media as a strategy to improve outcomes for the growing number of high-risk patients presenting for surgery.
Overarching Aim: The STRIVE Before Surgery Trial will evaluate three pragmatic elements (recruitment, adherence, and follow-up) that our experience in prehabilitation research demonstrate are necessary to support successful, large-scale evaluation. The investigators will concurrently use implementation science methodology to further refine processes for the larger trial. As this is a vanguard pilot trial, data from this trial will be combined with the future, large-scale trial.
Methods:
Design, setting and participants: The STRIVE Before Surgery Trial is an assessor blinded multicenter individual patient parallel-arm vanguard pragmatic randomized controlled trial.
People => 18 years old having inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery with expected length of stay of => 2 days will be included.
Intervention: The intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform.
Outcomes and sample size: Primary outcomes are monthly recruitment, intervention adherence, retention, and elicitation of patient, clinician and researcher-identified barriers. Secondary outcomes are days at home in the 30 days after surgery, survival, length of stay, patient safety indicators, intensive care unit admission, non-home discharge, readmission, emergency department visits, and health system costs. Our vanguard trial sample size estimate is informed by a power calculation for the future large-scale trial. For the vanguard trial, a sample size of 144 directly links to our 3 feasibility outcomes: 1) recruitment of 144 participants over 8-10 months at our 5 sites will demonstrate our ability to average 2-4 participants per site per month. To continue the momentum of the trial, the pilot sample size can increase up to a maximum of 190 participants, providing time for the research team to seamlessly launch the full-scale trial. The pilot phase will merge into the full-scale trial. Having flexibility in the pilot sample size will support this process.
Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.
Expected outcomes: Knowledge gained from our vanguard trial will directly inform the larger pragmatic trial, which will be powered to detect a minimally important difference in a patient-reported outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Prehabilitation interventionThe intervention includes 3 aspects (exercise, nutrition and breathing). Our intervention is a home-based multimodal prehabilitation program supported through an online platform. |
| Control | No intervention | –To support blinding, improve enrollment and reflect usual care, widely available physical activity (World Health Organization Recommendations for Physical Activity for ages 18-64 and >65) and healthy eating recommendations (Canada's Food Guide Snapshot) documents will be provided to control participants (without active or online support). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Scheduled, or on the pathway, for inpatient abdominal, thoracic, pelvic, head-and-neck or vascular surgery
- Expected surgery date between 3 and 12 weeks from enrollment
- Valid provincial health insurance number
- Access to internet-enabled device
Key exclusion criteria (10 listed)
- Inability to read and communicate in English
- Cognitive impairment preventing ability to provide informed consent independently
- No telephone/cell phone
- Cardiac, neurological or orthopedic procedure
- Surgery with no curative intent (palliative surgery)
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 |
|---|---|---|
| Prehabilitation interventionThe intervention consists of exercise, nutritional support and breathing techniques. The exercise component consists of 1) strength training; 2) cardio and 3) stretching. Participants will be encouraged to complete self-directed and/or group sessions >= 3 times per week. Each intervention participant will be provided a unique login to the virtual prehabilitation platform, which is the STRIVE Trial website. The nutrition component includes: 1) protein supplementation; 2) nutrition advice to support healthy eating. For the breathing component, participants will be encouraged to watch the video on Inspiratory Muscle Training (IMT) which involves diaphragmatic breathing and coughing/huffing. They will also be provided with an instruction booklet to take to hospital with them to support postoperative conduct of IMT during early recovery. | Behavioural | Intervention |
Primary outcome
Monthly recruitment
Time frame: 1 year
Recruited patients per center per month will be analyzed descriptively to generate a mean and standard deviation. Recruitment feasibility will be judged based on criteria pre-established that consider the number of available, committed sites in Ontario.
Intervention adherence
Time frame: pre-surgery
The proportion of prescribed prehabilitation tasks adhered to
Retention
Time frame: 1 month, year 1
The proportion of participants retained at 30-day patient-reported follow up will be calculated with a 95% confidence interval based on Wilson's method.
Elicitation of patient, clinician and researcher-identified barriers
Time frame: 1 year
For each target group, the frequency of domains identified as barriers will be calculated.
Patient-reported disability using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) (to be merged with larger trial)
Time frame: 1 month, 3 month, 1 year
The WHODAS is a patient-reported disability scale that assesses limitations in six major life domains (i.e., cognition, mobility, self-care, social interaction, life activities, participation in society). Each questionnaire item is scored on a Likert scale ranging from 0 to 4. The sum of the responses is the WHODAS Disability Score (range: 0 to 48), which is expressed as a percentage of the maximum possible score
11 secondary outcomes
Days at home (to be merged with larger trial)
Time frame: 1 month, 1 year
Survival (to be merged with larger trial)
Time frame: 1 year
Length of Stay (to be merged with larger trial)
Time frame: 1 year
Patient Safety Events (to be merged with larger trial)
Time frame: 1 year
Intensive care unit admission (to be merged with larger trial)
Time frame: 1 year
Non-home discharge (to be merged with larger trial)
Time frame: 1 year
Re-admission (to be merged with larger trial)
Time frame: 1 month, 1 year
Emergency department visits (to be merged with larger trial)
Time frame: 1 month, 1 year
Health system costs (to be merged with larger trial)
Time frame: 1 month, 1 year
Health Related Quality of Life using the EQ-5D-5L (to be merged with larger trial)
Time frame: 1 month, 3 month, 1 year
In-hospital complications
Time frame: Up to 1 month
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 4 Mar 2026.
- Derived from this study: PubMed 42027625McIsaac DI, Hallet J, Kidd G, Lee S, Taljaard M, Tandon P, Wijeysundera DN, Gillis C; STRIVE Trial Investigator Group. Home-based, virtually supported multimodal prehabilitation compared with usual care prior to major surgery: a multicentre, pragmatic pilot randomised trial. BJA Open. 2026 Apr 16;18:100550. doi: 10.1016/j.bjao.2026.100550. eCollection 2026 Jun.
- Derived from this study: PubMed 39510784McIsaac DI, Tandon P, Kidd G, Branje K, Hladkowicz E, Hallet J, Wijeysundera DN, Lee S, McNeely ML, Taljaard M, Gillis C; STRIVE Trial Investigators; Canadian Perioperative Anesthesia Clinical Trials Group (PACT). STRIVE pilot trial: a protocol for a multicentre pragmatic internal pilot randomised controlled trial of Structured TRaining to Improve fitness in a Virtual Environment (STRIVE) before surgery. BMJ Open. 2024 Nov 7;14(11):e093710. doi: 10.1136/bmjopen-2024-093710.
- Individual participant dataSharing planned: Yes. Individual participant data, including data dictionaries, will be available. This includes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The Study Protocol, Statistical Analysis Plan and Informed Consent Form will also be made available. Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data. Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.
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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.
Daniel McIsaac, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation intervention in people with Surgery-Complications and Disability Physical, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 6 inclusion and 10 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 4 Mar 2026. 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 Canada. 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?
Monthly recruitment (time frame: 1 year). The study lists 5 primary outcomes in all. 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 NCT06042491, 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 4 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.