Morton's NeuromaNCT05604144
Cryoanalgesia for the Treatment of Pain in Subjects With Morton's Neuroma
A study testing Cryoanalgesia (iovera°®) in people with Morton's Neuroma and Pain Management, run by Northern California Research Trials, Inc. at 2 sites in United States.
Trial summary
This is a Proof-of-Concept Trial to define the safety, efficacy and feasibility of a cryoanalgesic device (iovera°®) for the treatment of pain in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morton's Neuroma, Pain Management
- What is being tested?
- Cryoanalgesia (iovera°®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Aug 2022to 22 Apr 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
- Healthy adult male or female volunteers ages 18 or older.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
- Body Mass Index (BMI) ≥18 and ≤40 kg/m2.
- Unilateral Morton's Neuroma diagnosed by MRI.
- Subject has failed conservative treatment options.
Who cannot join
- Documented allergy, hypersensitivity, intolerance, or contraindication to amide-type local anesthetics (i.e., lidocaine), or opioids, NSAIDs.
- Documented history of uncontrolled diabetes, bleeding disorder, severe Peripheral Vascular Disease (PVD).
- Concurrent painful physical condition that may require analgesic treatment (i.e., long-term opioid use) which, in the Principal Investigator's opinion, may confound the treatment assessments.
- History of, suspected, or known addiction to/or abuse of illicit drug/s, prescription medicine/s, or alcohol within the past 3 years.
- Administration of an investigational drug or medical device within 30 days of the Screening Period.
- Previous participation in a cryoneurolysis study.
Show all 13Show fewer
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Principal Investigator, could potentially interfere with study assessments or compliance.
- Currently pregnant, nursing, or planning to become pregnant during the study.
- Clinically significant medical disease that, in the opinion of the Principal Investigator, would make participation in a clinical study inappropriate.
- Inadequate sensory function of the affected foot (as defined at the Screening Visit Neurologic Lower Extremity (LE) exams).
- Any clinically significant event or condition uncovered during the Screening Period (e.g., contra-lateral foot injury) that, in the opinion of the Principal Investigator, renders the subject medically unstable or complicates the subject's study participation.
- Subject has a history of: Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria or Raynaud's Disease.
- Subject has an active, wound, open and/or potential infection near the anticipated treatment site.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NorthBay Healthcare
Fairfield, California, 94534
NorthBay Healthcare
Vacaville, California, 95687
About this study
Official title: A Proof-of-Concept Study to Define the Safety, Efficacy and Feasibility of Cryoanalgesia (Iovera°®) for the Treatment of Pain in Subjects With Morton's Neuroma
This is a Proof-of-Concept Trial to define the safety, efficacy and feasibility of a cryoanalgesic device (iovera°®) for the treatment of pain in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies.
Read the detailed description
Hypothesis:
Cryoanalgesia (iovera°®) will provide a safe, effective and feasible tool as a pain medicine modality to offer analgesic pain relief in patients with Morton's Neuroma, thereby introducing a new non-opioid therapeutic option to these patients in need.
Primary Objective:
To define and characterize the analgesic effect following a single cryoanalgesic application to the Dorsal, Digital Proper Nerve/s in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies.
Primary Endpoints:
- The area under the curve of the Numeric Rating Scale (NRS) Pain Intensity Scores; the NRS is a 0 to 10 rating scale with the number "0" indicating "no pain" and the number "10" indicating the "worst possible pain". The NRS is completed by subjects three times per day from Day 0 to 3 months post treatment, then the NRS will be done weekly through 6 months post treatment. 2. The total daily opioid consumption will be evaluated from Day 0 to 6 months post treatment to determine if the cryoanalgesic treatment decreased the subject's daily opioid pain management requirement.
Secondary Objectives:
- Safety: To define the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related to treatment.
- Efficacy: To assess the cryoanalgesic application as defined by both the subject and physician; to define the impact of treatment related to ambulatory steps pre and post procedure.
- Feasibility: To characterize and compare the cryoanalgesic treatment process to Standard of Care (SOC) treatment modalities.
Secondary Endpoints:
- Safety Endpoints: The incidence of treatment emergent AEs and SAEs will be recorded and evaluated from the date of the cryoanalgesic application through 6 months post treatment.
- Efficacy Endpoints: Ambulatory steps/distance will be recorded during the Screening Period and through 90 days post treatment. A wrist device will track the subjects daily steps (ambulation) before and after the cryoanalgesic treatment. Tracking the subject's daily steps before and after treatment may offer an objective measure of cryoanalgesic efficacy. Both Subject and Physician Satisfaction Questionnaires will be recorded from Day 0 post-treatment through the following 6 months. These standardized questionnaires describe how satisfied or unsatisfied the subjects and physician are from the cryoanalgesic treatment.
- Feasibility Endpoints: Physician Feasibility Questionnaires will define treatment approaches, device utilization and impact on the subject's clinical course compared to Standard of Care treatment modalities.
- Conditions
- Morton's Neuroma, Pain Management
- Being tested
- Cryoanalgesia (iovera°®)
- Keywords
- Proof-of-Concept, Pilot Study, Podiatric Pain Management, Cryoanalgesia
- Medical subject headings
- Morton Neuroma, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoanalgesia (iovera°®)Device
Also called iovera°®
iovera°® treatment will be administered via ultrasound guidance to 1-2 branches of the dorsal/digital/proper nerve/s that innervate the Morton's neuroma. The treatment will be completed one time per subject.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Other | As a Proof of Concept Study, 5 subjects will follow the same protocol, with one cryoanalgesic treatment (iovera°®) with a 6 month clinical follow-up. Receives: Device: Cryoanalgesia (iovera°®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Management
Numeric Rating Scale (NRS) Pain Intensity Scores completed by subjects three times per day from Day 0 to 3 months post treatment, then NRS weekly through 6 months post treatment. 2. The total daily opioid consumption from Day 0 to 6 months post treatment.
Measured: Six Months
Secondary outcomes (3)
Adverse Events and Serious Adverse Events
The incidence of treatment emergent AEs and SAEs will be recorded and evaluated from the date of the treatment through 6 months post treatment.
Measured: Six Months
Ambulation
Ambulatory steps/distance will be recorded during the Screening Period and through 90 days post treatment. Both Subject and Physician Satisfaction Questionnaires will be recorded from Day 0 post-treatment through the following 6 months.
Measured: Six Months
Medical Device Feasibility
Physician Feasibility Questionnaires will define treatment approaches, device utilization and impact on the subject's clinical course compared to SOC treatment modalities.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start22 Aug 2022
- Primary completion22 Apr 2023 (estimated)
- Study completion22 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Morton's NeuromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof-of-Concept
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern California Research Trials, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc, NorthBay Healthcare
- Responsible party
- Sponsor
- Investigators
- Kevin M Miller, DPM, FACPM, FFPM, Principal investigator, NorthBay Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604144
- Sponsor's protocol ID
- IITMN001
- Status last verified
- Nov 2022
- First submitted
- 4 Oct 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cleveland Clinic Communication: Morton's Neuroma: Causes, Symptoms, Diagnois & Treatment. https://my.cleveland clinic.org/health/diseases/15118-mortons-neuroma pages 1-13.
Matthews BG, Hurn SE, Harding MP, Henry RA, Ware RS. The effectiveness of non-surgical interventions for common plantar digital compressive neuropathy (Morton's neuroma): a systematic review and meta-analysis. J Foot Ankle Res. 2019 Feb 13;12:12. doi: 10.1186/s13047-019-0320-7. eCollection 2019.
PubMed 30809275Sidon E, Rogero R, McDonald E, Daecher A, Shakked R, Pedowitz DI, Fuchs D, Daniel JN, Raikin SM. Prevalence of Neuropathic Pain Symptoms in Foot and Ankle Patients. Foot Ankle Int. 2019 Jun;40(6):629-633. doi: 10.1177/1071100719838302. Epub 2019 Mar 22.
PubMed 30902025Thomson L, Aujla RS, Divall P, Bhatia M. Non-surgical treatments for Morton's neuroma: A systematic review. Foot Ankle Surg. 2020 Oct;26(7):736-743. doi: 10.1016/j.fas.2019.09.009. Epub 2019 Nov 2.
PubMed 31718949Ferkel E, Davis WH, Ellington JK. Entrapment Neuropathies of the Foot and Ankle. Clin Sports Med. 2015 Oct;34(4):791-801. doi: 10.1016/j.csm.2015.06.002.
PubMed 26409596Ross AB, Jacobs A, Williams KL, Bour RK, Gyftopoulos S. Ultrasound-Guided Injection Treatments Versus Surgical Neurectomy for Morton Neuroma: A Cost-Effectiveness Analysis. AJR Am J Roentgenol. 2022 Feb;218(2):234-240. doi: 10.2214/AJR.21.26419. Epub 2021 Sep 15.
PubMed 34523955Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.
PubMed 28336454Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016 Jun;23(3):523-8. doi: 10.1016/j.knee.2016.01.011. Epub 2016 Feb 10.
PubMed 26875052Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.
PubMed 29095245Poppler LH, Parikh RP, Bichanich MJ, Rebehn K, Bettlach CR, Mackinnon SE, Moore AM. Surgical interventions for the treatment of painful neuroma: a comparative meta-analysis. Pain. 2018 Feb;159(2):214-223. doi: 10.1097/j.pain.0000000000001101.
PubMed 29189515
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Study to Define the Safety, Efficacy and Feasibility of Cryoanalgesia (Iovera°®) for the Treatment of Pain in Subjects With Morton's Neuroma
- ClinicalTrials.gov ID
- NCT05604144
- Acronym / sponsor ID
- IITMN001
- Conditions
- Morton's Neuroma, Pain Management
- Keywords
- Proof-of-Concept, Pilot Study, Podiatric Pain Management, Cryoanalgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Northern California Research Trials, Inc.University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc, NorthBay Healthcare
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 22 Apr 2023 (estimated)
- Study completion
- 22 Apr 2023 (estimated)
- First posted
- 3 Nov 2022 (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.
This is a Proof-of-Concept Trial to define the safety, efficacy and feasibility of a cryoanalgesic device (iovera°®) for the treatment of pain in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies.
Detailed description
Hypothesis:
Cryoanalgesia (iovera°®) will provide a safe, effective and feasible tool as a pain medicine modality to offer analgesic pain relief in patients with Morton's Neuroma, thereby introducing a new non-opioid therapeutic option to these patients in need.
Primary Objective:
To define and characterize the analgesic effect following a single cryoanalgesic application to the Dorsal, Digital Proper Nerve/s in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies.
Primary Endpoints:
- The area under the curve of the Numeric Rating Scale (NRS) Pain Intensity Scores; the NRS is a 0 to 10 rating scale with the number "0" indicating "no pain" and the number "10" indicating the "worst possible pain". The NRS is completed by subjects three times per day from Day 0 to 3 months post treatment, then the NRS will be done weekly through 6 months post treatment. 2. The total daily opioid consumption will be evaluated from Day 0 to 6 months post treatment to determine if the cryoanalgesic treatment decreased the subject's daily opioid pain management requirement.
Secondary Objectives:
- Safety: To define the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related to treatment.
- Efficacy: To assess the cryoanalgesic application as defined by both the subject and physician; to define the impact of treatment related to ambulatory steps pre and post procedure.
- Feasibility: To characterize and compare the cryoanalgesic treatment process to Standard of Care (SOC) treatment modalities.
Secondary Endpoints:
- Safety Endpoints: The incidence of treatment emergent AEs and SAEs will be recorded and evaluated from the date of the cryoanalgesic application through 6 months post treatment.
- Efficacy Endpoints: Ambulatory steps/distance will be recorded during the Screening Period and through 90 days post treatment. A wrist device will track the subjects daily steps (ambulation) before and after the cryoanalgesic treatment. Tracking the subject's daily steps before and after treatment may offer an objective measure of cryoanalgesic efficacy. Both Subject and Physician Satisfaction Questionnaires will be recorded from Day 0 post-treatment through the following 6 months. These standardized questionnaires describe how satisfied or unsatisfied the subjects and physician are from the cryoanalgesic treatment.
- Feasibility Endpoints: Physician Feasibility Questionnaires will define treatment approaches, device utilization and impact on the subject's clinical course compared to Standard of Care treatment modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof-of-Concept
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Other | Device: Cryoanalgesia (iovera°®)As a Proof of Concept Study, 5 subjects will follow the same protocol, with one cryoanalgesic treatment (iovera°®) with a 6 month clinical follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adult male or female volunteers ages 18 or older.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
- Body Mass Index (BMI) ≥18 and ≤40 kg/m2.
- Unilateral Morton's Neuroma diagnosed by MRI.
- Subject has failed conservative treatment options.
Key exclusion criteria (13 listed)
- Documented allergy, hypersensitivity, intolerance, or contraindication to amide-type local anesthetics (i.e., lidocaine), or opioids, NSAIDs.
- Documented history of uncontrolled diabetes, bleeding disorder, severe Peripheral Vascular Disease (PVD).
- Concurrent painful physical condition that may require analgesic treatment (i.e., long-term opioid use) which, in the Principal Investigator's opinion, may confound the treatment assessments.
- History of, suspected, or known addiction to/or abuse of illicit drug/s, prescription medicine/s, or alcohol within the past 3 years.
- Administration of an investigational drug or medical device within 30 days of the Screening Period.
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 |
|---|---|---|
| Cryoanalgesia (iovera°®)Also: iovera°®iovera°® treatment will be administered via ultrasound guidance to 1-2 branches of the dorsal/digital/proper nerve/s that innervate the Morton's neuroma. The treatment will be completed one time per subject. | Device | Active Treatment |
Primary outcome
Pain Management
Time frame: Six Months
Numeric Rating Scale (NRS) Pain Intensity Scores completed by subjects three times per day from Day 0 to 3 months post treatment, then NRS weekly through 6 months post treatment. 2. The total daily opioid consumption from Day 0 to 6 months post treatment.
3 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: Six Months
Ambulation
Time frame: Six Months
Medical Device Feasibility
Time frame: Six Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- BackgroundCleveland Clinic Communication: Morton's Neuroma: Causes, Symptoms, Diagnois & Treatment. https://my.cleveland clinic.org/health/diseases/15118-mortons-neuroma pages 1-13.
- Background: PubMed 30809275Matthews BG, Hurn SE, Harding MP, Henry RA, Ware RS. The effectiveness of non-surgical interventions for common plantar digital compressive neuropathy (Morton's neuroma): a systematic review and meta-analysis. J Foot Ankle Res. 2019 Feb 13;12:12. doi: 10.1186/s13047-019-0320-7. eCollection 2019.
- Background: PubMed 30902025Sidon E, Rogero R, McDonald E, Daecher A, Shakked R, Pedowitz DI, Fuchs D, Daniel JN, Raikin SM. Prevalence of Neuropathic Pain Symptoms in Foot and Ankle Patients. Foot Ankle Int. 2019 Jun;40(6):629-633. doi: 10.1177/1071100719838302. Epub 2019 Mar 22.
- Background: PubMed 31718949Thomson L, Aujla RS, Divall P, Bhatia M. Non-surgical treatments for Morton's neuroma: A systematic review. Foot Ankle Surg. 2020 Oct;26(7):736-743. doi: 10.1016/j.fas.2019.09.009. Epub 2019 Nov 2.
- Background: PubMed 26409596Ferkel E, Davis WH, Ellington JK. Entrapment Neuropathies of the Foot and Ankle. Clin Sports Med. 2015 Oct;34(4):791-801. doi: 10.1016/j.csm.2015.06.002.
- Background: PubMed 34523955Ross AB, Jacobs A, Williams KL, Bour RK, Gyftopoulos S. Ultrasound-Guided Injection Treatments Versus Surgical Neurectomy for Morton Neuroma: A Cost-Effectiveness Analysis. AJR Am J Roentgenol. 2022 Feb;218(2):234-240. doi: 10.2214/AJR.21.26419. Epub 2021 Sep 15.
- Background: PubMed 28336454Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.
- Background: PubMed 26875052Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016 Jun;23(3):523-8. doi: 10.1016/j.knee.2016.01.011. Epub 2016 Feb 10.
- Background: PubMed 29095245Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.
- Background: PubMed 29189515Poppler LH, Parikh RP, Bichanich MJ, Rebehn K, Bettlach CR, Mackinnon SE, Moore AM. Surgical interventions for the treatment of painful neuroma: a comparative meta-analysis. Pain. 2018 Feb;159(2):214-223. doi: 10.1097/j.pain.0000000000001101.
- 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.
Kevin M Miller, DPM, FACPM, FFPM principal investigator
NorthBay Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoanalgesia (iovera°®) in people with Morton's Neuroma and Pain Management, run by Northern California Research Trials, Inc. at 2 sites in United States.
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 5 inclusion and 13 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 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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?
Pain Management (time frame: Six Months). 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 NCT05604144, which also lists 10 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 21 Nov 2022.