Peripheral Vascular DiseasesNCT06391346
Investigation of the Perfusion of Gluteal Muscle in Patients With Intermittent Gluteal Claudication by Non-invasive MSOT
A study testing MSOT in people with Peripheral Vascular Diseases and Peripheral Arterial Disease, run by Ulrich Rother at 1 site in Germany.
Trial summary
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the gluteal muscle based on multispectral optoacoustic tomography (MSOT) in patients with gluteal claudication in Fontaine stage II (intermittent claudication) pre and post-intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Intermittent Claudication
- What is being tested?
- MSOT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jun 2023to Apr 2024
- 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
- Patient with gluteal claudication in Fontaine stage II and corresponding stenosis (common iliac artery, internal iliac artery or distal aorta)
Who cannot join
- Patients with PAD in Fontaine stage I, III and IV or Rutherford category 0, 4, 5 and 6 or healthy volunteers with diabetes mellitus, chronic renal failure, claudication symptoms, abnormal ABI or non-palpable foot pulses
- People with age under 18
- Absence of written consent
- Safety concerns of the study physician (person with physical, mental or psychiatric conditions which, by the judgement of the study physician, would compromise the person's safety or the quality of the data, thereby rendering the person an ineligible candidate for the study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
Erlangen, Bavaria, 91054
Ulrich Rother, Dr. med., +4991318542028, ulrich.rother@uk-erlangen.de
Werner Lang, Prof. Dr. med., +4991318532968, werner.lang@uk-erlangen.de
About this study
Official title: Evaluation of Gluteal Muscle Perfusion in Patients With Intermittent Gluteal Claudication by Non-invasive Multispectral Optoacoustic Tomography With Pre-post Study Design
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the gluteal muscle based on multispectral optoacoustic tomography (MSOT) in patients with gluteal claudication in Fontaine stage II (intermittent claudication) pre and post-intervention.
Read the detailed description
This is a monocentric, prospective study which aims to exanimate the optoacoustic signals in gluteal muscle after a exercise in patients with PAD in Fontaine stage II before and after the revascularisation to verify the change of MSOT by improved vascularization. MSOT data will be correlated with CCDS, ABI, treadmill test, subjectively perceived absolute walking distance in everyday life, PAD-related life quality (VASCUQOL-6) and TASC II classification in angiographic imaging (only in case angiographic imaging is available and independent from this study).
Patients with gluteal claudication in Fontaine stage II will be recruited during the consulting hours of the Department of Vascular Surgery, University Hospital Erlangen. Following detailed information about the study and after providing written consent, relevant clinical data will be collected from the electronical patient file, if available. In addition, a thorough anamnesis interview for relevant data and CCDS would be performed. Afterwards, the MSOT parameters will be recorded on gluteal muscles before and after a stepper exercise two minutes or until the occurrence of claudication pain in the gluteal muscle. The more affected side is examined. All data will be adequately pseudonymized in compliance with data protection regulations before they are used for statistical analysis. The duration of the study for participants will be max. 90 minutes. The angiographic imaging will be reviewed and analyzed.
- Conditions
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Intermittent Claudication, Gluteal Claudication
- Being tested
- MSOT
- Keywords
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Peripheral Artery Disease, PAD, Gluteal claudication, Buttock claudication, MSOT, Multispectral Optoacoustic Tomography
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSOTDiagnostic test
Non-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus gluteus of the affected leg in PAD patients in Fontaine stage II (intermittent claudication)
Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / treadmill test / stepper exercise 2 minutes Receives: Diagnostic Test: MSOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal diagnostic MSOT thresholds
optimal diagnostic threshold for hemoglobin-associated MSOT parameters in gluteal muscle tissue in patients with intermittent claudication before and after exercise
Measured: twice (before and after the intervention, up to two weeks)
Improvement of the MSOT parameters after the revascularisation
Change of hemoglobin-associated MSOT parameters in gluteal muscle tissue in patients with intermittent claudication before and after exercise after the revascularisation
Measured: twice (before and after the intervention, up to two weeks)
Secondary outcomes (9)
Difference between the corresponding MSOT values before and after exercis
Difference of the values before and after exercise for hemoglobin-associated parameters derived by transcutaneous MSOT in patients with gluteal claudication
Measured: twice (before and after the intervention, up to two weeks)
Reperfusion profiles for hemoglobin-associated parameters
Curves of hemoglobin-associated MSOT parameters in the first ten minutes after exercise
Measured: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with the CCDS flow profile and PSV
Hemoglobin-associated MSOT parameters in patients with gluteal claudication correlated with the flow profile and PSV of A. femoralis communis and A. poplitea determined by CCDS
Measured: single time point
Correlation of acquired MSOT parameters with the ABI
Hemoglobin-associated parameters derived by transcutaneous MSOT correlated with the ABI
Measured: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with threadmill test
Hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with Threadmill test
Measured: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with subjectively perceived maximum walking distance in everyday life
hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the subjectively perceived maximum walking distance in everyday life
Measured: twice (before and after the intervention)
Correlation of acquired MSOT parameters with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)
hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)
Measured: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with the TASC-classification (angiography)
hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT in patients with PAD in Fontaine stage II correlated with the TASC-classification (angiography)
Measured: twice (before and after the intervention, up to two weeks)
Confounder analysis
Correlation of all collected parameters (anamnestic, demographic, physiological) with regard to their characteristics as basic confounders for the MSOT technique
Measured: twice (before and after the intervention, up to two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start23 Jun 2023
- Primary completion14 Mar 2024
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Perfusion parameters from MSOT would be measured on patients with gluteal claudication in Fontain stage 2 before and after the revascularisation.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulrich Rother
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulrich Rother, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391346
- Sponsor's protocol ID
- MSOT-gluteal
- Status last verified
- Apr 2024
- First submitted
- 20 Feb 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lawall H, Diehm C, Hoffmann U, Reinecke H. [Update PAVK: Epidemiology, comorbidity and prognosis of peripheral arterial obstructive disease]. Dtsch Med Wochenschr. 2015 Dec;140(24):1798-802. doi: 10.1055/s-0041-107064. Epub 2015 Dec 1. German.
PubMed 26625226Alpert JS, Larsen OA, Lassen NA. Exercise and intermittent claudication. Blood flow in the calf muscle during walking studied by the xenon-133 clearance method. Circulation. 1969 Mar;39(3):353-9. doi: 10.1161/01.cir.39.3.353. No abstract available.
PubMed 4885945Karlas A, Masthoff M, Kallmayer M, Helfen A, Bariotakis M, Fasoula NA, Schafers M, Seidensticker M, Eckstein HH, Ntziachristos V, Wildgruber M. Multispectral optoacoustic tomography of peripheral arterial disease based on muscle hemoglobin gradients-a pilot clinical study. Ann Transl Med. 2021 Jan;9(1):36. doi: 10.21037/atm-20-3321.
PubMed 33553329Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.
PubMed 28938901Abraham P, Picquet J, Vielle B, Sigaudo-Roussel D, Paisant-Thouveny F, Enon B, Saumet JL. Transcutaneous oxygen pressure measurements on the buttocks during exercise to detect proximal arterial ischemia: comparison with arteriography. Circulation. 2003 Apr 15;107(14):1896-900. doi: 10.1161/01.CIR.0000060500.60646.E0. Epub 2003 Mar 31.
PubMed 12668524Assi H, Cao R, Castelino M, Cox B, Gilbert FJ, Grohl J, Gurusamy K, Hacker L, Ivory AM, Joseph J, Knieling F, Leahy MJ, Lilaj L, Manohar S, Meglinski I, Moran C, Murray A, Oraevsky AA, Pagel MD, Pramanik M, Raymond J, Singh MKA, Vogt WC, Wang L, Yang S, Members Of Ipasc, Bohndiek SE. A review of a strategic roadmapping exercise to advance clinical translation of photoacoustic imaging: From current barriers to future adoption. Photoacoustics. 2023 Aug 2;32:100539. doi: 10.1016/j.pacs.2023.100539. eCollection 2023 Aug.
PubMed 37600964Audonnet M, Signolet I, Colas-Ribas C, Ammi M, Abraham P, Henni S. Exercise Transcutaneous Oximetry of the Buttocks - External Validation With Computed Tomography Angiography. Circ J. 2017 Jul 25;81(8):1123-1128. doi: 10.1253/circj.CJ-16-1316. Epub 2017 Apr 13.
PubMed 28413177Batt M, Baque J, Bouillanne PJ, Hassen-Khodja R, Haudebourg P, Thevenin B. Percutaneous angioplasty of the superior gluteal artery for buttock claudication: a report of seven cases and literature review. J Vasc Surg. 2006 May;43(5):987-91. doi: 10.1016/j.jvs.2006.01.024.
PubMed 16678694Gernigon M, Marchand J, Ouedraogo N, Leftheriotis G, Piquet JM, Abraham P. Proximal ischemia is a frequent cause of exercise-induced pain in patients with a normal ankle to brachial index at rest. Pain Physician. 2013 Jan;16(1):57-64.
PubMed 23340534
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gluteal Muscle Perfusion in Patients With Intermittent Gluteal Claudication by Non-invasive Multispectral Optoacoustic Tomography With Pre-post Study Design
- ClinicalTrials.gov ID
- NCT06391346
- Acronym / sponsor ID
- MSOT-gluteal
- Conditions
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Intermittent Claudication, Gluteal Claudication
- Keywords
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Peripheral Artery Disease, PAD, Gluteal claudication, Buttock claudication, MSOT, Multispectral Optoacoustic Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ulrich RotherUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- Apr 2024 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the gluteal muscle based on multispectral optoacoustic tomography (MSOT) in patients with gluteal claudication in Fontaine stage II (intermittent claudication) pre and post-intervention.
Detailed description
This is a monocentric, prospective study which aims to exanimate the optoacoustic signals in gluteal muscle after a exercise in patients with PAD in Fontaine stage II before and after the revascularisation to verify the change of MSOT by improved vascularization. MSOT data will be correlated with CCDS, ABI, treadmill test, subjectively perceived absolute walking distance in everyday life, PAD-related life quality (VASCUQOL-6) and TASC II classification in angiographic imaging (only in case angiographic imaging is available and independent from this study).
Patients with gluteal claudication in Fontaine stage II will be recruited during the consulting hours of the Department of Vascular Surgery, University Hospital Erlangen. Following detailed information about the study and after providing written consent, relevant clinical data will be collected from the electronical patient file, if available. In addition, a thorough anamnesis interview for relevant data and CCDS would be performed. Afterwards, the MSOT parameters will be recorded on gluteal muscles before and after a stepper exercise two minutes or until the occurrence of claudication pain in the gluteal muscle. The more affected side is examined. All data will be adequately pseudonymized in compliance with data protection regulations before they are used for statistical analysis. The duration of the study for participants will be max. 90 minutes. The angiographic imaging will be reviewed and analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Perfusion parameters from MSOT would be measured on patients with gluteal claudication in Fontain stage 2 before and after the revascularisation.
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Diagnostic Test: MSOTMultispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus gluteus of the affected leg in PAD patients in Fontaine stage II (intermittent claudication) Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / treadmill test / stepper exercise 2 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with gluteal claudication in Fontaine stage II and corresponding stenosis (common iliac artery, internal iliac artery or distal aorta)
Key exclusion criteria (4 listed)
- Patients with PAD in Fontaine stage I, III and IV or Rutherford category 0, 4, 5 and 6 or healthy volunteers with diabetes mellitus, chronic renal failure, claudication symptoms, abnormal ABI or non-palpable foot pulses
- People with age under 18
- Absence of written consent
- Safety concerns of the study physician (person with physical, mental or psychiatric conditions which, by the judgement of the study physician, would compromise the person's safety or the quality of the data, thereby rendering the person an ineligible candidate for the study
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 |
|---|---|---|
| MSOTNon-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses | Diagnostic test | Patient |
Primary outcome
Optimal diagnostic MSOT thresholds
Time frame: twice (before and after the intervention, up to two weeks)
optimal diagnostic threshold for hemoglobin-associated MSOT parameters in gluteal muscle tissue in patients with intermittent claudication before and after exercise
Improvement of the MSOT parameters after the revascularisation
Time frame: twice (before and after the intervention, up to two weeks)
Change of hemoglobin-associated MSOT parameters in gluteal muscle tissue in patients with intermittent claudication before and after exercise after the revascularisation
9 secondary outcomes
Difference between the corresponding MSOT values before and after exercis
Time frame: twice (before and after the intervention, up to two weeks)
Reperfusion profiles for hemoglobin-associated parameters
Time frame: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with the CCDS flow profile and PSV
Time frame: single time point
Correlation of acquired MSOT parameters with the ABI
Time frame: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with threadmill test
Time frame: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with subjectively perceived maximum walking distance in everyday life
Time frame: twice (before and after the intervention)
Correlation of acquired MSOT parameters with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)
Time frame: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with the TASC-classification (angiography)
Time frame: twice (before and after the intervention, up to two weeks)
Confounder analysis
Time frame: twice (before and after the intervention, up to two weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Results publication: PubMed 26625226Lawall H, Diehm C, Hoffmann U, Reinecke H. [Update PAVK: Epidemiology, comorbidity and prognosis of peripheral arterial obstructive disease]. Dtsch Med Wochenschr. 2015 Dec;140(24):1798-802. doi: 10.1055/s-0041-107064. Epub 2015 Dec 1. German.
- Results publication: PubMed 4885945Alpert JS, Larsen OA, Lassen NA. Exercise and intermittent claudication. Blood flow in the calf muscle during walking studied by the xenon-133 clearance method. Circulation. 1969 Mar;39(3):353-9. doi: 10.1161/01.cir.39.3.353. No abstract available.
- Results publication: PubMed 33553329Karlas A, Masthoff M, Kallmayer M, Helfen A, Bariotakis M, Fasoula NA, Schafers M, Seidensticker M, Eckstein HH, Ntziachristos V, Wildgruber M. Multispectral optoacoustic tomography of peripheral arterial disease based on muscle hemoglobin gradients-a pilot clinical study. Ann Transl Med. 2021 Jan;9(1):36. doi: 10.21037/atm-20-3321.
- Results publication: PubMed 28938901Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.
- Results publication: PubMed 12668524Abraham P, Picquet J, Vielle B, Sigaudo-Roussel D, Paisant-Thouveny F, Enon B, Saumet JL. Transcutaneous oxygen pressure measurements on the buttocks during exercise to detect proximal arterial ischemia: comparison with arteriography. Circulation. 2003 Apr 15;107(14):1896-900. doi: 10.1161/01.CIR.0000060500.60646.E0. Epub 2003 Mar 31.
- Results publication: PubMed 37600964Assi H, Cao R, Castelino M, Cox B, Gilbert FJ, Grohl J, Gurusamy K, Hacker L, Ivory AM, Joseph J, Knieling F, Leahy MJ, Lilaj L, Manohar S, Meglinski I, Moran C, Murray A, Oraevsky AA, Pagel MD, Pramanik M, Raymond J, Singh MKA, Vogt WC, Wang L, Yang S, Members Of Ipasc, Bohndiek SE. A review of a strategic roadmapping exercise to advance clinical translation of photoacoustic imaging: From current barriers to future adoption. Photoacoustics. 2023 Aug 2;32:100539. doi: 10.1016/j.pacs.2023.100539. eCollection 2023 Aug.
- Results publication: PubMed 28413177Audonnet M, Signolet I, Colas-Ribas C, Ammi M, Abraham P, Henni S. Exercise Transcutaneous Oximetry of the Buttocks - External Validation With Computed Tomography Angiography. Circ J. 2017 Jul 25;81(8):1123-1128. doi: 10.1253/circj.CJ-16-1316. Epub 2017 Apr 13.
- Results publication: PubMed 16678694Batt M, Baque J, Bouillanne PJ, Hassen-Khodja R, Haudebourg P, Thevenin B. Percutaneous angioplasty of the superior gluteal artery for buttock claudication: a report of seven cases and literature review. J Vasc Surg. 2006 May;43(5):987-91. doi: 10.1016/j.jvs.2006.01.024.
- Results publication: PubMed 23340534Gernigon M, Marchand J, Ouedraogo N, Leftheriotis G, Piquet JM, Abraham P. Proximal ischemia is a frequent cause of exercise-induced pain in patients with a normal ankle to brachial index at rest. Pain Physician. 2013 Jan;16(1):57-64.
- 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.
University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
Erlangen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSOT in people with Peripheral Vascular Diseases and Peripheral Arterial Disease, run by Ulrich Rother at 1 site in Germany.
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 1 inclusion and 4 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 30 Apr 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 Germany. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal diagnostic MSOT thresholds (time frame: twice (before and after the intervention, up to two weeks)). The study lists 2 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 NCT06391346, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.