Neuromuscular BlockadeNCT06236763
Comparison of Neuromuscular Recovery at the Hand and Foot
An observational study of Neuromuscular Blockade, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
Gold standard for neuromuscular blockade evaluation is accelerometry in three dimensions at the thumb. There are many times that measurement at the hand can be falsely under-estimated intraoperatively secondary to constriction of the upper extremities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- TOFscan foot
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2024to 1 Jul 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any patient scheduled for more than 2 hours extra cavitary surgery where muscle relaxation spontaneous reversal will not interfere with the completion of the planned surgical procedure.
Who may be able to join
- ASA 1-3 patients
- Elective surgery
- Undergoing general anesthesia with rocuronium induced NMB
- BMI < 36 kg.m-2
- Age > 18 years old
- French or English speaking patient
Who cannot join
- Renal or hepatic dysfunction
- Obstructive sleep apnea requiring continuous positive airway pressure (CPAP) machine
- Neuromuscular disease
- Peripheral arterial disease (suspected, known or investigated)
- Calcium channel anomalies
- Hypothermia (< 35C)
Show all 9Show fewer
- Hyper/hypomagnasemia
- Allergy to any drug used in the study protocol
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Ile de Montréal
Montreal, Quebec, H1T 2M4
Louis-Philippe Fortier, MD, 514-252-3426, lpfortier.hmr@ssss.gouv.qc.ca
Nicolas Lacroix, MD
About this study
Official title: Comparison of the TOFscan Simultaneous Measures at the Thumb and the First Toe During Recovery of Neuromuscular Function Following Rocuronium Administration
Gold standard for neuromuscular blockade evaluation is accelerometry in three dimensions at the thumb. There are many times that measurement at the hand can be falsely under-estimated intraoperatively secondary to constriction of the upper extremities. We believe that installing the same accelerometer at the first toe will give us similar readings for both neuromuscular blockade and recovery from rocuronium administration. This study focuses on agreement values between two accelerometers installed on the hand and at on the foot.
Read the detailed description
The development of advanced competence in laparoscopic surgery, robotic surgery and the broadening of indications for partial or total laparoscopy techniques created a novel environment where patients need to be deeply paralyzed and positioned in form fitting mattresses to ensure high quality exposure and security in extreme positioning. It is now undisputed that clinical evaluation done any other way than by a objective neuromuscular function monitor may produce faulty conclusions. The elements of the operating setup force anesthesiologists to adapt the way they monitor muscle relaxation since the hands are generally not available for neuromuscular function monitoring. In order to measure properly the level of residual paralysis, the thumb must be able to move freely in a device creating a light preloading on the adductor pollicis allowing to evaluate the force generated during standardized stimulation through accelerometry, the TOFscan device. The corrugator supercilli and orbicularis oculi muscles, an alternate positioning for the accelerometer is sometimes the fallback spot for monitoring. The problem with that muscle is that it does not have the same time curve sensitivity to muscle relaxant than the perilaryngeal muscle have. The investigators are looking for a good representation of the level of patency of the perilaryngeal muscle to ensure that the patient will be able to breath normally after extubation, they must turn to another target. Previous observations have suggested that the monitoring of the hallux flexor muscle could represent a valid alternative. The confirmation of this hypothesis would allow for easy, reproducible, evaluation of the level of muscle relaxation at the perilaryngeal muscles, helping to procure safer conditions for tracheal extubation. Neuromuscular blocking agents (NMBAs) are administered by anesthesiologists during general anesthesia to facilitate endotracheal intubation and/or surgical conditions. Postoperative residual neuromuscular blockade (rNMB), is an adverse event frequently observed after extubation in the postanesthesia care unit (PACU) after surgery. rNMB is associated with upper airway obstruction, reduced pharyngeal muscle coordination, decreased functional residual capacity, and impaired hypoxic ventilatory response and may lead to critical cardiopulmonary complications. To prevent those complications, monitoring NMBAs activity and timely and adequate dosage of reversal agents necessitate precise and valid monitoring.
The current literature supports the exclusive use of quantitative measurements of residual paralysis, subjective monitoring caries to much error in evaluating the level of blockade and is responsible for PACU residual paralysis and its complications. It is well accepted that no amount of rNMB is acceptable (TOF < 1) around extubation periods, a necessary step to ensure safety that relies on timely and correct dosage of the reversal agents.
When TOFscan measures are done on partially mobile thumbs, or transducers positioned in non-optimal fashion, the measure observed (deep blockade) will either delay the reversal procedure because of presumed very deep level paralysis or suggest high doses of reversal agents at a significant cost.
The investigators are confident that validating the measures done at the hallux flexor will allow for easy, relevant and valid estimation of residual paralysis and create a safer environment for muscle relaxation reversal and extubation.
- Conditions
- Neuromuscular Blockade
- Being tested
- TOFscan foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOFscan footDevice
TOFscan will be applied on the foot and recovery from neuromuscular blockade will be observed over time. These will be compared with the control (TOFscan at the hand) on the same patient (gold standard monitor).
| Study group | Role | What they receive |
|---|---|---|
| Observation and control | Two accelerometers will be applied on each patient; observation (foot) and control (hand, also the gold standard). Agreement values will be compared between these two monitors. Receives: Device: TOFscan foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of neuromuscular blockade (NMB) recovery
Time required for train-of-four (TOF) > 0.9 for the two TOFscans
Measured: 60 minutes
Secondary outcomes (3)
Neuromuscular blockade onset
Time to train-of-four (TOF) count of 0 for both monitors
Measured: 3 minutes
Reversal
Train-of-four ratio (TOF) immediately before reversal agent administration on both monitors
Measured: 60 minutes
Extubation
Train-of-four (TOF) ratio at extubation
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies 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
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Philippe Fortier, Ciusss de L'Est de l'Île de Montréal
- Investigators
- 514-252-3426 Fortier, MD, Principal investigator, Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Ile de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236763
- Sponsor's protocol ID
- 2024-3609
- Status last verified
- Mar 2024
- First submitted
- 16 Jan 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.
PubMed 28044330Unterbuchner C, Ehehalt K, Graf B. [Algorithm-based preventive strategies for avoidance of residual neuromuscular blocks]. Anaesthesist. 2019 Nov;68(11):744-754. doi: 10.1007/s00101-019-00677-6. German.
PubMed 31650189D'Honneur G, Guignard B, Slavov V, Ruggier R, Duvaldestin P. Comparison of the neuromuscular blocking effect of atracurium and vecuronium on the adductor pollicis and the geniohyoid muscle in humans. Anesthesiology. 1995 Mar;82(3):649-54. doi: 10.1097/00000542-199503000-00006.
PubMed 7879933Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.
PubMed 25902322Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
PubMed 18635478Errando CL, Garutti I, Mazzinari G, Diaz-Cambronero O, Bebawy JF; Grupo Espanol De Estudio Del Bloqueo Neuromuscular. Residual neuromuscular blockade in the postanesthesia care unit: observational cross-sectional study of a multicenter cohort. Minerva Anestesiol. 2016 Dec;82(12):1267-1277. Epub 2016 May 27.
PubMed 27232277Saager L, Maiese EM, Bash LD, Meyer TA, Minkowitz H, Groudine S, Philip BK, Tanaka P, Gan TJ, Rodriguez-Blanco Y, Soto R, Heisel O. Incidence, risk factors, and consequences of residual neuromuscular block in the United States: The prospective, observational, multicenter RECITE-US study. J Clin Anesth. 2019 Aug;55:33-41. doi: 10.1016/j.jclinane.2018.12.042. Epub 2018 Dec 27.
PubMed 30594097Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400.
PubMed 30130260Viby-Mogensen J, Jensen NH, Engbaek J, Ording H, Skovgaard LT, Chraemmer-Jorgensen B. Tactile and visual evaluation of the response to train-of-four nerve stimulation. Anesthesiology. 1985 Oct;63(4):440-3. doi: 10.1097/00000542-198510000-00015. No abstract available.
PubMed 4037404Brull SJ, Silverman DG. Visual and tactile assessment of neuromuscular fade. Anesth Analg. 1993 Aug;77(2):352-5. doi: 10.1213/00000539-199308000-00024.
PubMed 8394051Naguib M, Brull SJ, Kopman AF, Hunter JM, Fulesdi B, Arkes HR, Elstein A, Todd MM, Johnson KB. Consensus Statement on Perioperative Use of Neuromuscular Monitoring. Anesth Analg. 2018 Jul;127(1):71-80. doi: 10.1213/ANE.0000000000002670.
PubMed 29200077Kirov K, Motamed C, Dhonneur G. Differential sensitivity of abdominal muscles and the diaphragm to mivacurium: an electromyographic study. Anesthesiology. 2001 Dec;95(6):1323-8. doi: 10.1097/00000542-200112000-00008.
PubMed 11748387Plaud B, Debaene B, Donati F. The corrugator supercilii, not the orbicularis oculi, reflects rocuronium neuromuscular blockade at the laryngeal adductor muscles. Anesthesiology. 2001 Jul;95(1):96-101. doi: 10.1097/00000542-200107000-00019.
PubMed 11465590Dhonneur G, Kirov K, Slavov V, Duvaldestin P. Effects of an intubating dose of succinylcholine and rocuronium on the larynx and diaphragm: an electromyographic study in humans. Anesthesiology. 1999 Apr;90(4):951-5. doi: 10.1097/00000542-199904000-00004.
PubMed 10201662
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the TOFscan Simultaneous Measures at the Thumb and the First Toe During Recovery of Neuromuscular Function Following Rocuronium Administration
- ClinicalTrials.gov ID
- NCT06236763
- Acronym / sponsor ID
- 2024-3609
- Conditions
- Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 1 Feb 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.
Gold standard for neuromuscular blockade evaluation is accelerometry in three dimensions at the thumb. There are many times that measurement at the hand can be falsely under-estimated intraoperatively secondary to constriction of the upper extremities. We believe that installing the same accelerometer at the first toe will give us similar readings for both neuromuscular blockade and recovery from rocuronium administration. This study focuses on agreement values between two accelerometers installed on the hand and at on the foot.
Detailed description
The development of advanced competence in laparoscopic surgery, robotic surgery and the broadening of indications for partial or total laparoscopy techniques created a novel environment where patients need to be deeply paralyzed and positioned in form fitting mattresses to ensure high quality exposure and security in extreme positioning. It is now undisputed that clinical evaluation done any other way than by a objective neuromuscular function monitor may produce faulty conclusions. The elements of the operating setup force anesthesiologists to adapt the way they monitor muscle relaxation since the hands are generally not available for neuromuscular function monitoring. In order to measure properly the level of residual paralysis, the thumb must be able to move freely in a device creating a light preloading on the adductor pollicis allowing to evaluate the force generated during standardized stimulation through accelerometry, the TOFscan device. The corrugator supercilli and orbicularis oculi muscles, an alternate positioning for the accelerometer is sometimes the fallback spot for monitoring. The problem with that muscle is that it does not have the same time curve sensitivity to muscle relaxant than the perilaryngeal muscle have. The investigators are looking for a good representation of the level of patency of the perilaryngeal muscle to ensure that the patient will be able to breath normally after extubation, they must turn to another target. Previous observations have suggested that the monitoring of the hallux flexor muscle could represent a valid alternative. The confirmation of this hypothesis would allow for easy, reproducible, evaluation of the level of muscle relaxation at the perilaryngeal muscles, helping to procure safer conditions for tracheal extubation. Neuromuscular blocking agents (NMBAs) are administered by anesthesiologists during general anesthesia to facilitate endotracheal intubation and/or surgical conditions. Postoperative residual neuromuscular blockade (rNMB), is an adverse event frequently observed after extubation in the postanesthesia care unit (PACU) after surgery. rNMB is associated with upper airway obstruction, reduced pharyngeal muscle coordination, decreased functional residual capacity, and impaired hypoxic ventilatory response and may lead to critical cardiopulmonary complications. To prevent those complications, monitoring NMBAs activity and timely and adequate dosage of reversal agents necessitate precise and valid monitoring.
The current literature supports the exclusive use of quantitative measurements of residual paralysis, subjective monitoring caries to much error in evaluating the level of blockade and is responsible for PACU residual paralysis and its complications. It is well accepted that no amount of rNMB is acceptable (TOF < 1) around extubation periods, a necessary step to ensure safety that relies on timely and correct dosage of the reversal agents.
When TOFscan measures are done on partially mobile thumbs, or transducers positioned in non-optimal fashion, the measure observed (deep blockade) will either delay the reversal procedure because of presumed very deep level paralysis or suggest high doses of reversal agents at a significant cost.
The investigators are confident that validating the measures done at the hallux flexor will allow for easy, relevant and valid estimation of residual paralysis and create a safer environment for muscle relaxation reversal and extubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation and control | – | Device: TOFscan footTwo accelerometers will be applied on each patient; observation (foot) and control (hand, also the gold standard). Agreement values will be compared between these two monitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient scheduled for more than 2 hours extra cavitary surgery where muscle relaxation spontaneous reversal will not interfere with the completion of the planned surgical procedure.
Key inclusion criteria (6 listed)
- ASA 1-3 patients
- Elective surgery
- Undergoing general anesthesia with rocuronium induced NMB
- BMI < 36 kg.m-2
- Age > 18 years old
Key exclusion criteria (9 listed)
- Renal or hepatic dysfunction
- Obstructive sleep apnea requiring continuous positive airway pressure (CPAP) machine
- Neuromuscular disease
- Peripheral arterial disease (suspected, known or investigated)
- Calcium channel anomalies
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 |
|---|---|---|
| TOFscan footTOFscan will be applied on the foot and recovery from neuromuscular blockade will be observed over time. These will be compared with the control (TOFscan at the hand) on the same patient (gold standard monitor). | Device | Observation and control |
Primary outcome
Time of neuromuscular blockade (NMB) recovery
Time frame: 60 minutes
Time required for train-of-four (TOF) > 0.9 for the two TOFscans
3 secondary outcomes
Neuromuscular blockade onset
Time frame: 3 minutes
Reversal
Time frame: 60 minutes
Extubation
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Results publication: PubMed 28044330Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.
- Results publication: PubMed 31650189Unterbuchner C, Ehehalt K, Graf B. [Algorithm-based preventive strategies for avoidance of residual neuromuscular blocks]. Anaesthesist. 2019 Nov;68(11):744-754. doi: 10.1007/s00101-019-00677-6. German.
- Results publication: PubMed 7879933D'Honneur G, Guignard B, Slavov V, Ruggier R, Duvaldestin P. Comparison of the neuromuscular blocking effect of atracurium and vecuronium on the adductor pollicis and the geniohyoid muscle in humans. Anesthesiology. 1995 Mar;82(3):649-54. doi: 10.1097/00000542-199503000-00006.
- Results publication: PubMed 25902322Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.
- Results publication: PubMed 18635478Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
- Results publication: PubMed 27232277Errando CL, Garutti I, Mazzinari G, Diaz-Cambronero O, Bebawy JF; Grupo Espanol De Estudio Del Bloqueo Neuromuscular. Residual neuromuscular blockade in the postanesthesia care unit: observational cross-sectional study of a multicenter cohort. Minerva Anestesiol. 2016 Dec;82(12):1267-1277. Epub 2016 May 27.
- Results publication: PubMed 30594097Saager L, Maiese EM, Bash LD, Meyer TA, Minkowitz H, Groudine S, Philip BK, Tanaka P, Gan TJ, Rodriguez-Blanco Y, Soto R, Heisel O. Incidence, risk factors, and consequences of residual neuromuscular block in the United States: The prospective, observational, multicenter RECITE-US study. J Clin Anesth. 2019 Aug;55:33-41. doi: 10.1016/j.jclinane.2018.12.042. Epub 2018 Dec 27.
- Results publication: PubMed 30130260Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400.
- Results publication: PubMed 4037404Viby-Mogensen J, Jensen NH, Engbaek J, Ording H, Skovgaard LT, Chraemmer-Jorgensen B. Tactile and visual evaluation of the response to train-of-four nerve stimulation. Anesthesiology. 1985 Oct;63(4):440-3. doi: 10.1097/00000542-198510000-00015. No abstract available.
- Results publication: PubMed 8394051Brull SJ, Silverman DG. Visual and tactile assessment of neuromuscular fade. Anesth Analg. 1993 Aug;77(2):352-5. doi: 10.1213/00000539-199308000-00024.
- Results publication: PubMed 29200077Naguib M, Brull SJ, Kopman AF, Hunter JM, Fulesdi B, Arkes HR, Elstein A, Todd MM, Johnson KB. Consensus Statement on Perioperative Use of Neuromuscular Monitoring. Anesth Analg. 2018 Jul;127(1):71-80. doi: 10.1213/ANE.0000000000002670.
- Results publication: PubMed 11748387Kirov K, Motamed C, Dhonneur G. Differential sensitivity of abdominal muscles and the diaphragm to mivacurium: an electromyographic study. Anesthesiology. 2001 Dec;95(6):1323-8. doi: 10.1097/00000542-200112000-00008.
- 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.
514-252-3426 Fortier, MD principal investigator
Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Ile de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade, run by Ciusss de L'Est de l'Île de Montréal 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 9 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis-Philippe Fortier, MD (514-252-3426 ext. 3808, lpfortier.hmr@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of neuromuscular blockade (NMB) recovery (time frame: 60 minutes). 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 NCT06236763, which also lists 14 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 8 Mar 2024.