Spinal Cord InjuriesNCT05888714
Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle
A study testing Experimental FES cycling, Comparator FES cycling and Conventional physical therapy in people with Spinal Cord Injuries and Brain Injuries, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Feasibility study of a new medical device that will evaluate the usability and effectiveness of a cycle ergometer device associated with neuromuscular electrical stimulation (FES cycling). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Brain Injuries, Muscle Atrophy
- What is being tested?
- Experimental FES cycling, Comparator FES cycling and Conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2023to 31 Dec 2023
- 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
- Spinal cord injury, brain injury or acquired muscle weakness
- Managed chronic diseases
- No contraindications to the practice of physical exercise
- Ability to communicate in oral and written Portuguese
Who cannot join
- Amputation of lower limbs at any level
- Unstable or acute fractures of lower limbs
- Contraindication for the practice of physical activity
- Open wounds in the lower limbs
- Consent withdraw
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 04116-030
About this study
Official title: Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle: Healthy or Deprived of Central Nervous System Control
Feasibility study of a new medical device that will evaluate the usability and effectiveness of a cycle ergometer device associated with neuromuscular electrical stimulation (FES cycling). The study's objective is to evaluate the effect of the application of functional electrical stimulation of the new device on participants' quadriceps muscle strength in comparison to a medical device with similar characteristics and to a control group. Secondarily, the study will compare the usability of the two medical devices as evaluated by the participants and the therapists who apply the treatment, as well as the participants' satisfaction with the treatment, identifying possible adverse effects.
- Conditions
- Spinal Cord Injuries, Brain Injuries, Muscle Atrophy
- Being tested
- Experimental FES cycling, Comparator FES cycling, Conventional physical therapy
- Medical subject headings
- Spinal Cord Injuries, Brain Injuries, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental FES cyclingDevice
Using the experimental, new FES cycling device, provide neuromuscular electrical stimulation of the gluteal, quadriceps and hamstring muscles at sufficient intensity to cause muscle contraction and push the cycle ergometer pedals for 30 minutes, for 16 treatment sessions (twice a week, for 8 weeks), in addition to conventional physical therapy for muscle strengthening.
Comparator FES cyclingDevice
Using the comparator, marketed FES cycling device, provide neuromuscular electrical stimulation of the gluteal, quadriceps and hamstring muscles at sufficient intensity to cause muscle contraction and push the cycle ergometer pedals for 30 minutes, for 16 treatment sessions (twice a week, for 8 weeks), in addition to conventional physical therapy for muscle strengthening.
Conventional physical therapyOther
Conventional physical therapy for muscle strengthening, for 16 treatment sessions (twice a week, for 8 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Experimental FES cycling | Experimental | New medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling) Receives: Device: Experimental FES cycling |
| Comparator FES cycling | Active comparator | Existing medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling) Receives: Device: Comparator FES cycling |
| Conventional physical therapy | Active comparator | Conventional physical therapy. Receives: Other: Conventional physical therapy |
| Operators | No intervention | Operators will evaluate systems usability during interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee joint extensors peak torque (Newton-Meters)
Quadriceps muscle strength, measured by isokinetic dynamometry
Measured: Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation
Change in knee joint flexors peak torque (Newton-Meters)
Quadriceps muscle strength, measured by isokinetic dynamometry
Measured: Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation
Change in thigh perimeter (centimeters)
Quadriceps muscle integrity, measured by thigh volumetry
Measured: Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation
Change in rectus femoris thickness (centimeters)
Rectus femoris muscle structural integrity, measured by ultrasound
Measured: Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation
Change in vastus intermedius thickness (centimeters)
Vastus intermedius muscle structural integrity, measured by ultrasound
Measured: Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation
Secondary outcomes (3)
System Usability Score
Systems usability, measured by self-referred survey (0-100, the higher the score, the better the outcome)
Measured: System usability at end of intervention, completed 8 weeks after initiation
Patients Perception of Treatment Outcomes Score
Satisfaction, measured by self-referred survey (6-30, the higher the score, the better the outcome)
Measured: Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation
Adverse effects inventory
Qualitative evaluation of adverse effects, if any
Measured: Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agência Brasileira de Desenvolvimento Industrial (Brazilian Agency For Industrial Development)
- Responsible party
- Sponsor
- Investigators
- Linamara R. Battistella, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888714
- Sponsor's protocol ID
- CAAE 64324122.0.0000.0068
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
PubMed 18191684Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
PubMed 10816184Scheuringer M, Grill E, Boldt C, Mittrach R, Mullner P, Stucki G. Systematic review of measures and their concepts used in published studies focusing on rehabilitation in the acute hospital and in early post-acute rehabilitation facilities. Disabil Rehabil. 2005 Apr 8-22;27(7-8):419-29. doi: 10.1080/09638280400014089.
PubMed 16040545De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. doi: 10.1097/01.ccm.0000281450.01881.d8.
PubMed 17855814De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
PubMed 12472328Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
PubMed 18511703Stoll T, Brach M, Huber EO, Scheuringer M, Schwarzkopf SR, Konstanjsek N, Stucki G. ICF Core Set for patients with musculoskeletal conditions in the acute hospital. Disabil Rehabil. 2005 Apr 8-22;27(7-8):381-7. doi: 10.1080/09638280400013990.
PubMed 16040540van der Schaaf M, Beelen A, Dongelmans DA, Vroom MB, Nollet F. Poor functional recovery after a critical illness: a longitudinal study. J Rehabil Med. 2009 Nov;41(13):1041-8. doi: 10.2340/16501977-0443.
PubMed 19893999Martin UJ, Hincapie L, Nimchuk M, Gaughan J, Criner GJ. Impact of whole-body rehabilitation in patients receiving chronic mechanical ventilation. Crit Care Med. 2005 Oct;33(10):2259-65. doi: 10.1097/01.ccm.0000181730.02238.9b.
PubMed 16215380Garnacho-Montero J, Amaya-Villar R, Garcia-Garmendia JL, Madrazo-Osuna J, Ortiz-Leyba C. Effect of critical illness polyneuropathy on the withdrawal from mechanical ventilation and the length of stay in septic patients. Crit Care Med. 2005 Feb;33(2):349-54. doi: 10.1097/01.ccm.0000153521.41848.7e.
PubMed 15699838Dittmer DK, Teasell R. Complications of immobilization and bed rest. Part 1: Musculoskeletal and cardiovascular complications. Can Fam Physician. 1993 Jun;39:1428-32, 1435-7.
PubMed 8324411Pinheiro AR, Christofoletti G. Motor physical therapy in hospitalized patients in an intensive care unit: a systematic review. Rev Bras Ter Intensiva. 2012 Jun;24(2):188-96. English, Portuguese.
PubMed 23917769Maddocks M, Armstrong S, Wilcock A. Exercise as a supportive therapy in incurable cancer: exploring patient preferences. Psychooncology. 2011 Feb;20(2):173-8. doi: 10.1002/pon.1720.
PubMed 20333769
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle: Healthy or Deprived of Central Nervous System Control
- ClinicalTrials.gov ID
- NCT05888714
- Acronym / sponsor ID
- CAAE 64324122.0.0000.0068
- Conditions
- Spinal Cord Injuries, Brain Injuries, Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Agência Brasileira de Desenvolvimento Industrial (Brazilian Agency For Industrial Development)
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Jun 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.
Feasibility study of a new medical device that will evaluate the usability and effectiveness of a cycle ergometer device associated with neuromuscular electrical stimulation (FES cycling). The study's objective is to evaluate the effect of the application of functional electrical stimulation of the new device on participants' quadriceps muscle strength in comparison to a medical device with similar characteristics and to a control group. Secondarily, the study will compare the usability of the two medical devices as evaluated by the participants and the therapists who apply the treatment, as well as the participants' satisfaction with the treatment, identifying possible adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental FES cycling | Experimental | Device: Experimental FES cyclingNew medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling) |
| Comparator FES cycling | Active comparator | Device: Comparator FES cyclingExisting medical device combining cycle ergometer use and neuromuscular electrical stimulation (FES cycling) |
| Conventional physical therapy | Active comparator | Other: Conventional physical therapyConventional physical therapy. |
| Operators | No intervention | –Operators will evaluate systems usability during interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spinal cord injury, brain injury or acquired muscle weakness
- Managed chronic diseases
- No contraindications to the practice of physical exercise
- Ability to communicate in oral and written Portuguese
Key exclusion criteria (5 listed)
- Amputation of lower limbs at any level
- Unstable or acute fractures of lower limbs
- Contraindication for the practice of physical activity
- Open wounds in the lower limbs
- Consent withdraw
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 |
|---|---|---|
| Experimental FES cyclingUsing the experimental, new FES cycling device, provide neuromuscular electrical stimulation of the gluteal, quadriceps and hamstring muscles at sufficient intensity to cause muscle contraction and push the cycle ergometer pedals for 30 minutes, for 16 treatment sessions (twice a week, for 8 weeks), in addition to conventional physical therapy for muscle strengthening. | Device | Experimental FES cycling |
| Comparator FES cyclingUsing the comparator, marketed FES cycling device, provide neuromuscular electrical stimulation of the gluteal, quadriceps and hamstring muscles at sufficient intensity to cause muscle contraction and push the cycle ergometer pedals for 30 minutes, for 16 treatment sessions (twice a week, for 8 weeks), in addition to conventional physical therapy for muscle strengthening. | Device | Comparator FES cycling |
| Conventional physical therapyConventional physical therapy for muscle strengthening, for 16 treatment sessions (twice a week, for 8 weeks). | Other | Conventional physical therapy |
Primary outcome
Change in knee joint extensors peak torque (Newton-Meters)
Time frame: Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation
Quadriceps muscle strength, measured by isokinetic dynamometry
Change in knee joint flexors peak torque (Newton-Meters)
Time frame: Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation
Quadriceps muscle strength, measured by isokinetic dynamometry
Change in thigh perimeter (centimeters)
Time frame: Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation
Quadriceps muscle integrity, measured by thigh volumetry
Change in rectus femoris thickness (centimeters)
Time frame: Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation
Rectus femoris muscle structural integrity, measured by ultrasound
Change in vastus intermedius thickness (centimeters)
Time frame: Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation
Vastus intermedius muscle structural integrity, measured by ultrasound
3 secondary outcomes
System Usability Score
Time frame: System usability at end of intervention, completed 8 weeks after initiation
Patients Perception of Treatment Outcomes Score
Time frame: Patients perception of treatment outcomes at end of intervention, completed 8 weeks after initiation
Adverse effects inventory
Time frame: Adverse effects at end of each treatment session with the assigned intervention, completed 30min after session initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Results publication: PubMed 18191684Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.
- Results publication: PubMed 10816184Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
- Results publication: PubMed 16040545Scheuringer M, Grill E, Boldt C, Mittrach R, Mullner P, Stucki G. Systematic review of measures and their concepts used in published studies focusing on rehabilitation in the acute hospital and in early post-acute rehabilitation facilities. Disabil Rehabil. 2005 Apr 8-22;27(7-8):419-29. doi: 10.1080/09638280400014089.
- Results publication: PubMed 17855814De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. doi: 10.1097/01.ccm.0000281450.01881.d8.
- Results publication: PubMed 12472328De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
- Results publication: PubMed 18511703Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
- Results publication: PubMed 16040540Stoll T, Brach M, Huber EO, Scheuringer M, Schwarzkopf SR, Konstanjsek N, Stucki G. ICF Core Set for patients with musculoskeletal conditions in the acute hospital. Disabil Rehabil. 2005 Apr 8-22;27(7-8):381-7. doi: 10.1080/09638280400013990.
- Results publication: PubMed 19893999van der Schaaf M, Beelen A, Dongelmans DA, Vroom MB, Nollet F. Poor functional recovery after a critical illness: a longitudinal study. J Rehabil Med. 2009 Nov;41(13):1041-8. doi: 10.2340/16501977-0443.
- Results publication: PubMed 16215380Martin UJ, Hincapie L, Nimchuk M, Gaughan J, Criner GJ. Impact of whole-body rehabilitation in patients receiving chronic mechanical ventilation. Crit Care Med. 2005 Oct;33(10):2259-65. doi: 10.1097/01.ccm.0000181730.02238.9b.
- Results publication: PubMed 15699838Garnacho-Montero J, Amaya-Villar R, Garcia-Garmendia JL, Madrazo-Osuna J, Ortiz-Leyba C. Effect of critical illness polyneuropathy on the withdrawal from mechanical ventilation and the length of stay in septic patients. Crit Care Med. 2005 Feb;33(2):349-54. doi: 10.1097/01.ccm.0000153521.41848.7e.
- Results publication: PubMed 8324411Dittmer DK, Teasell R. Complications of immobilization and bed rest. Part 1: Musculoskeletal and cardiovascular complications. Can Fam Physician. 1993 Jun;39:1428-32, 1435-7.
- Results publication: PubMed 23917769Pinheiro AR, Christofoletti G. Motor physical therapy in hospitalized patients in an intensive care unit: a systematic review. Rev Bras Ter Intensiva. 2012 Jun;24(2):188-96. English, Portuguese.
- 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.
Linamara R. Battistella, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental FES cycling, Comparator FES cycling and Conventional physical therapy in people with Spinal Cord Injuries and Brain Injuries, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 inclusion and 5 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 5 Jun 2023. 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 Brazil. 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 André T. Sugawara, MD, PhD (55-11-5180-7897, andre.sugawara@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee joint extensors peak torque (Newton-Meters) (time frame: Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation). 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 NCT05888714, which also lists 13 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 5 Jun 2023.