Skeletal Muscle AtrophyPoEMSNCT05997095
Post-operative Electrical Muscle Stimulation to Stimulate Muscle Protein Synthesis in Humans
A study testing Neuromuscular electrical stimulation (NMES/0 in people with Skeletal Muscle Atrophy, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Atrophy
- What is being tested?
- Neuromuscular electrical stimulation (NMES/0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2023to 28 Dec 2025
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60-85 y
- Willing and able to give informed consent for participation in the study
Who cannot join
- BMI <18.5 or >35kg/m2
- Participation in any regular, structured RET within the past 6 months
- Musculoskeletal disorders
- Severe respiratory disease:
- COPD
- Pulmonary hypertension
Show all 27Show fewer
- Neurological disorders:
- Cerebrovascular disease (cerebral haemorrhage; cerebral ischemic stroke)
- Intracranial space-occupying lesion
- Epilepsy
- Metabolic disease:
- Hyper and hypo parathyroidism
- Untreated hyper and hypothyroidism
- Cushing's disease
- Type 1 or 2 diabetes
- Active cardiovascular problems:
- Uncontrolled hypertension (BP>160/100mmHg)
- Recent cardiac event
- Heart failure (Class III/IV)
- Arrhythmia
- Angina
- Blood clotting disorders
- Active inflammatory bowel or renal disease
- Recent malignancy (in previous 3 years)
- Recent steroid treatment within 6 months or hormone replacement therapy
- Family history of early (<55yrs) death from cardiovascular disease
- Known sensitivity to Sonovue
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
About this study
Official title: Optimisation of Post-operative Electrical Muscle Stimulation (PoEMS) to Stimulate Muscle Protein Synthesis in Humans
Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. Undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many communicable and non-communicable diseases including ageing, bed-rest/immobilisation, cancer and physical inactivity. As such, the design of optimal strategies (e.g., different types of exercise) to "offset" these detrimental losses of muscle is a focus for both researchers and clinicians.
One situation where losses of muscle mass occur very quickly (i.e., within a few days) is after surgery. However, at this time, most people (especially if they have had major abdominal or lower-limb surgery) are not able to perform exercise and as such a different strategy to maintain muscle mass needs to be found. It has been shown that electrical stimulation of the leg muscles can maintain muscle mass and function in patients after surgery. It is not however yet known, what the optimal electrical stimulation regime is to preserve muscle mass during situations of disuse.
This study aims to examine the impact of three different electrical stimulation protocols on muscle building processes in individuals age-matched to those most commonly presenting for major abdominal surgery. This information will then be used in a clinical trial of surgical patients to see if it can preserve their muscle mass and function in the post-operative period.
Read the detailed description
The contraction of skeletal muscles depends on the regulation of the nervous system and the coordination of neuromuscular function. The smallest motor nervous system associated with muscle contraction is the motor unit (MU), which consists of an efferent motor neuron and all of the muscle fibres it innervates. Muscle tissue also undergoes adaptive alternations in response to external stimuli, such as the gradual decline in muscle mass and strength during ageing, and atrophy following muscle disuse. A number of studies have demonstrated that different types of voluntary movements, such as resistance exercise training (RET), can prevent or attenuate such alternations to a certain extent via increases in muscle protein synthesis (MPS).
However, certain situations such as post-operative bed rest render RET interventions an unachievable option. Neuromuscular electrical stimulation (NMES) can be applied as a surrogate; acting to evoke involuntary contraction of the target muscles via electrical current applied to the muscle belly. Although NMES stimulation has been widely tested in the intensive care environment, results have shown variable efficacy- perhaps due to the multi-organ failure and associated catabolic systemic environment encountered by the majority of these patients.
It has recently shown that in post-operative abdominal surgery patients, 5-days of NMES, performed at frequency of 30 Hz in a 1 second "on", 1 second "off" contraction pattern, can mitigate losses in muscle mass and function. However, this study 'borrowed' a protocol from previous intensive care literature, and as such may not be optimal with regards to frequency or contraction pattern. Given that this protocol was highly tolerated by patients in a previous study (i.e., based on 30 min of daily NMES, patients in this study said they would tolerate it for 45 to 240 (mean 90) min), it is plausible that higher frequency NMES (~100 Hz), enabling greater force production may be both viable and result in further mitigation of muscle mass and function losses. It has also been demonstrated that the time muscle is under loaded tension during RET may be an important modulator of MPS and subsequent gains in muscle mass. Therefore, increasing the contraction relative to relaxation time during NMES (e.g., 3 seconds on, 1 second off) may be another feasible and perhaps more beneficial strategy to reduce muscle mass losses in populations where an increase in frequency may not be possible or tolerable.
Knowing that muscle maintenance is based on a dynamic equilibrium between MPS and muscle protein breakdown, the impact of different NMES protocols on MPS, associated cell signalling, and nutrient delivery pathways needs to be explored so that an optimal intervention can be tested in clinical settings associated with disuse atrophy. To date, no previous studies have compared differing frequencies of NMES on the muscle metabolic responses in older adults, nor the effect of differing NMES-induced contraction patterns.
- Conditions
- Skeletal Muscle Atrophy
- Being tested
- Neuromuscular electrical stimulation (NMES/0
- Keywords
- Muscle, Protein Synthesis, Neuromuscular electrical stimulation, Muscle blood flow
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation (NMES/0Other
NMES will be applied for 30 min and will be delivered using an approved, CE-marked device (Premier Combo Plus, Med-Fit Ltd, UK) using two large (7.5 × 13 cm) electrodes placed proximally and distally over the lateral quadriceps. The set protocols will be pre-programmed into to the device and the amplitude value will match the setting that was determined during a familiarisation visit
| Study group | Role | What they receive |
|---|---|---|
| 30Hz (low-intensity) | Active comparator | Volunteers receive 30 mins of neuromuscular electrical stimulation at 30Hz with a contraction pattern of 1 second "on" and 1 second "off" Receives: Other: Neuromuscular electrical stimulation (NMES/0 |
| 100Hz (higher-intensity) | Experimental | Volunteers receive 30 mins of neuromuscular electrical stimulation at 100Hz with a contraction pattern of 1 second "on" and 1 second "off" Receives: Other: Neuromuscular electrical stimulation (NMES/0 |
| 30Hz (low-intensity, 3:1) | Experimental | Volunteers receive 30 mins of neuromuscular electrical stimulation at 30Hz with a contraction pattern of 3 seconds "on" and 1 second "off" Receives: Other: Neuromuscular electrical stimulation (NMES/0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Protein Synthesis
A primed continuous infusion of a stable isotope tracer (1,2 13C2] leucine) will be initiated (Prime: 0.7 mg/kg; Constant: 1.0 mg/kg/h) at time 0h. After 60 min of stable isotope infusion, a single muscle biopsy will be taken from one leg. Another biopsy from the same leg will be taken 120 min later, and a third 240 min after the second to provide rates of muscle protein synthesis in the rested condition and in response to NMES, respectively. The fractional synthetic rate (FSR) of the myofibrillar fraction was calculated from the incorporation of [1,2 13C2] leucine, using venous plasma labelling between muscle biopsies to represent the immediate precursor for protein synthesis. This will give a rate (%/hour) of muscle protein synthesis.
Measured: 4 hours
Secondary outcomes (2)
Skeletal Muscle Anabolic Signalling
Total and phosphorylation of established anabolic proteins in human skeletal muscle will be quantified via Western Blotting.
Measured: 4 hours
Skeletal Muscle Blood Flow
Contrast enhanced ultrasound (CEUS) measurements will be made 60 min before the NMES and 30 min after. To achieve this, a custom-made probe holder will be placed on the leg to be stimulated at the start of the study. For each measurement, Sonovue will be infused at 2ml/min for 1 minute and then 1ml/min for 30 sec to achieve systemic steady state, with a continued infusion at 1ml/min for the duration of the measurements. Each measurement will include three, 30-second capture-flash cycles which will form a Sonovue replenishment curve for the portion of vastus lateralis muscle (VL) under the probe. blood flow will be calculated by measuring the reperfusion rate of the microbubbles in the muscle microvasculature following destruction with a high mechanical index flash, given the infusion of contrast is continuous.
Measured: Baseline and 30 minutes post neuromuscular stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start22 May 2023
- Primary completion28 Sep 2025 (estimated)
- Study completion28 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Skeletal Muscle AtrophyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethan Phillips, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997095
- Sponsor's protocol ID
- FMHS 261-0423
- Acronym
- PoEMS
- Status last verified
- Apr 2025
- First submitted
- 10 Aug 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hardy EJ, Hatt J, Doleman B, Smart TF, Piasecki M, Lund JN, Phillips BE. Post-operative electrical muscle stimulation attenuates loss of muscle mass and function following major abdominal surgery in older adults: a split body randomised control trial. Age Ageing. 2022 Oct 6;51(10):afac234. doi: 10.1093/ageing/afac234.
PubMed 36315433Hardy EJO, Inns TB, Hatt J, Doleman B, Bass JJ, Atherton PJ, Lund JN, Phillips BE. The time course of disuse muscle atrophy of the lower limb in health and disease. J Cachexia Sarcopenia Muscle. 2022 Dec;13(6):2616-2629. doi: 10.1002/jcsm.13067. Epub 2022 Sep 14.
PubMed 36104842Wall BT, Dirks ML, Verdijk LB, Snijders T, Hansen D, Vranckx P, Burd NA, Dendale P, van Loon LJ. Neuromuscular electrical stimulation increases muscle protein synthesis in elderly type 2 diabetic men. Am J Physiol Endocrinol Metab. 2012 Sep 1;303(5):E614-23. doi: 10.1152/ajpendo.00138.2012. Epub 2012 Jun 26.
PubMed 22739107Mancinelli R, Toniolo L, Di Filippo ES, Doria C, Marrone M, Maroni CR, Verratti V, Bondi D, Maccatrozzo L, Pietrangelo T, Fulle S. Neuromuscular Electrical Stimulation Induces Skeletal Muscle Fiber Remodeling and Specific Gene Expression Profile in Healthy Elderly. Front Physiol. 2019 Nov 27;10:1459. doi: 10.3389/fphys.2019.01459. eCollection 2019.
PubMed 31827446Burd NA, Andrews RJ, West DW, Little JP, Cochran AJ, Hector AJ, Cashaback JG, Gibala MJ, Potvin JR, Baker SK, Phillips SM. Muscle time under tension during resistance exercise stimulates differential muscle protein sub-fractional synthetic responses in men. J Physiol. 2012 Jan 15;590(2):351-62. doi: 10.1113/jphysiol.2011.221200. Epub 2011 Nov 21.
PubMed 22106173
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Post-operative Electrical Muscle Stimulation (PoEMS) to Stimulate Muscle Protein Synthesis in Humans
- ClinicalTrials.gov ID
- NCT05997095
- Acronym / sponsor ID
- PoEMS / FMHS 261-0423
- Conditions
- Skeletal Muscle Atrophy
- Keywords
- Muscle, Protein Synthesis, Neuromuscular electrical stimulation, Muscle blood flow
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 28 Sep 2025 (estimated)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 18 Aug 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.
Skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. Undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many communicable and non-communicable diseases including ageing, bed-rest/immobilisation, cancer and physical inactivity. As such, the design of optimal strategies (e.g., different types of exercise) to "offset" these detrimental losses of muscle is a focus for both researchers and clinicians.
One situation where losses of muscle mass occur very quickly (i.e., within a few days) is after surgery. However, at this time, most people (especially if they have had major abdominal or lower-limb surgery) are not able to perform exercise and as such a different strategy to maintain muscle mass needs to be found. It has been shown that electrical stimulation of the leg muscles can maintain muscle mass and function in patients after surgery. It is not however yet known, what the optimal electrical stimulation regime is to preserve muscle mass during situations of disuse.
This study aims to examine the impact of three different electrical stimulation protocols on muscle building processes in individuals age-matched to those most commonly presenting for major abdominal surgery. This information will then be used in a clinical trial of surgical patients to see if it can preserve their muscle mass and function in the post-operative period.
Detailed description
The contraction of skeletal muscles depends on the regulation of the nervous system and the coordination of neuromuscular function. The smallest motor nervous system associated with muscle contraction is the motor unit (MU), which consists of an efferent motor neuron and all of the muscle fibres it innervates. Muscle tissue also undergoes adaptive alternations in response to external stimuli, such as the gradual decline in muscle mass and strength during ageing, and atrophy following muscle disuse. A number of studies have demonstrated that different types of voluntary movements, such as resistance exercise training (RET), can prevent or attenuate such alternations to a certain extent via increases in muscle protein synthesis (MPS).
However, certain situations such as post-operative bed rest render RET interventions an unachievable option. Neuromuscular electrical stimulation (NMES) can be applied as a surrogate; acting to evoke involuntary contraction of the target muscles via electrical current applied to the muscle belly. Although NMES stimulation has been widely tested in the intensive care environment, results have shown variable efficacy- perhaps due to the multi-organ failure and associated catabolic systemic environment encountered by the majority of these patients.
It has recently shown that in post-operative abdominal surgery patients, 5-days of NMES, performed at frequency of 30 Hz in a 1 second "on", 1 second "off" contraction pattern, can mitigate losses in muscle mass and function. However, this study 'borrowed' a protocol from previous intensive care literature, and as such may not be optimal with regards to frequency or contraction pattern. Given that this protocol was highly tolerated by patients in a previous study (i.e., based on 30 min of daily NMES, patients in this study said they would tolerate it for 45 to 240 (mean 90) min), it is plausible that higher frequency NMES (~100 Hz), enabling greater force production may be both viable and result in further mitigation of muscle mass and function losses. It has also been demonstrated that the time muscle is under loaded tension during RET may be an important modulator of MPS and subsequent gains in muscle mass. Therefore, increasing the contraction relative to relaxation time during NMES (e.g., 3 seconds on, 1 second off) may be another feasible and perhaps more beneficial strategy to reduce muscle mass losses in populations where an increase in frequency may not be possible or tolerable.
Knowing that muscle maintenance is based on a dynamic equilibrium between MPS and muscle protein breakdown, the impact of different NMES protocols on MPS, associated cell signalling, and nutrient delivery pathways needs to be explored so that an optimal intervention can be tested in clinical settings associated with disuse atrophy. To date, no previous studies have compared differing frequencies of NMES on the muscle metabolic responses in older adults, nor the effect of differing NMES-induced contraction patterns.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30Hz (low-intensity) | Active comparator | Other: Neuromuscular electrical stimulation (NMES/0Volunteers receive 30 mins of neuromuscular electrical stimulation at 30Hz with a contraction pattern of 1 second "on" and 1 second "off" |
| 100Hz (higher-intensity) | Experimental | Other: Neuromuscular electrical stimulation (NMES/0Volunteers receive 30 mins of neuromuscular electrical stimulation at 100Hz with a contraction pattern of 1 second "on" and 1 second "off" |
| 30Hz (low-intensity, 3:1) | Experimental | Other: Neuromuscular electrical stimulation (NMES/0Volunteers receive 30 mins of neuromuscular electrical stimulation at 30Hz with a contraction pattern of 3 seconds "on" and 1 second "off" |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 60-85 y
- Willing and able to give informed consent for participation in the study
Key exclusion criteria (27 listed)
- BMI <18.5 or >35kg/m2
- Participation in any regular, structured RET within the past 6 months
- Musculoskeletal disorders
- Severe respiratory disease:
- COPD
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 |
|---|---|---|
| Neuromuscular electrical stimulation (NMES/0NMES will be applied for 30 min and will be delivered using an approved, CE-marked device (Premier Combo Plus, Med-Fit Ltd, UK) using two large (7.5 × 13 cm) electrodes placed proximally and distally over the lateral quadriceps. The set protocols will be pre-programmed into to the device and the amplitude value will match the setting that was determined during a familiarisation visit | Other | 100Hz (higher-intensity), 30Hz (low-intensity), 30Hz (low-intensity, 3:1) |
Primary outcome
Skeletal Muscle Protein Synthesis
Time frame: 4 hours
A primed continuous infusion of a stable isotope tracer (1,2 13C2] leucine) will be initiated (Prime: 0.7 mg/kg; Constant: 1.0 mg/kg/h) at time 0h. After 60 min of stable isotope infusion, a single muscle biopsy will be taken from one leg. Another biopsy from the same leg will be taken 120 min later, and a third 240 min after the second to provide rates of muscle protein synthesis in the rested condition and in response to NMES, respectively. The fractional synthetic rate (FSR) of the myofibrillar fraction was calculated from the incorporation of [1,2 13C2] leucine, using venous plasma labelling between muscle biopsies to represent the immediate precursor for protein synthesis. This will give a rate (%/hour) of muscle protein synthesis.
2 secondary outcomes
Skeletal Muscle Anabolic Signalling
Time frame: 4 hours
Skeletal Muscle Blood Flow
Time frame: Baseline and 30 minutes post neuromuscular stimulation
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 2 May 2025.
- Background: PubMed 36315433Hardy EJ, Hatt J, Doleman B, Smart TF, Piasecki M, Lund JN, Phillips BE. Post-operative electrical muscle stimulation attenuates loss of muscle mass and function following major abdominal surgery in older adults: a split body randomised control trial. Age Ageing. 2022 Oct 6;51(10):afac234. doi: 10.1093/ageing/afac234.
- Background: PubMed 36104842Hardy EJO, Inns TB, Hatt J, Doleman B, Bass JJ, Atherton PJ, Lund JN, Phillips BE. The time course of disuse muscle atrophy of the lower limb in health and disease. J Cachexia Sarcopenia Muscle. 2022 Dec;13(6):2616-2629. doi: 10.1002/jcsm.13067. Epub 2022 Sep 14.
- Background: PubMed 22739107Wall BT, Dirks ML, Verdijk LB, Snijders T, Hansen D, Vranckx P, Burd NA, Dendale P, van Loon LJ. Neuromuscular electrical stimulation increases muscle protein synthesis in elderly type 2 diabetic men. Am J Physiol Endocrinol Metab. 2012 Sep 1;303(5):E614-23. doi: 10.1152/ajpendo.00138.2012. Epub 2012 Jun 26.
- Background: PubMed 31827446Mancinelli R, Toniolo L, Di Filippo ES, Doria C, Marrone M, Maroni CR, Verratti V, Bondi D, Maccatrozzo L, Pietrangelo T, Fulle S. Neuromuscular Electrical Stimulation Induces Skeletal Muscle Fiber Remodeling and Specific Gene Expression Profile in Healthy Elderly. Front Physiol. 2019 Nov 27;10:1459. doi: 10.3389/fphys.2019.01459. eCollection 2019.
- Background: PubMed 22106173Burd NA, Andrews RJ, West DW, Little JP, Cochran AJ, Hector AJ, Cashaback JG, Gibala MJ, Potvin JR, Baker SK, Phillips SM. Muscle time under tension during resistance exercise stimulates differential muscle protein sub-fractional synthetic responses in men. J Physiol. 2012 Jan 15;590(2):351-62. doi: 10.1113/jphysiol.2011.221200. Epub 2011 Nov 21.
- 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.
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 Neuromuscular electrical stimulation (NMES/0 in people with Skeletal Muscle Atrophy, run by University of Nottingham 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 2 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 2 May 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?
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?
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?
Skeletal Muscle Protein Synthesis (time frame: 4 hours). 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 NCT05997095, which also lists 5 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 2 May 2025.