Degenerative Disc DiseaseNCT04056520
Clinical and Radiological Outcomes of Posterior Cervical Fusion with Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
An observational study of Degenerative Disc Disease, run by Ohio State University at 1 site in United States.
Trial summary
This study is being done to prospectively collect data on subjects having posterior cervical fusion surgery using the Medtronic Infinity system. Researchers plan to collect information from patients having this type of surgery in order to learn more about patient how patients do after the surgery, including the rate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Medtronic Infinity Occipitocervical-Upper Thoracic System using the O-arm Imaging System and StealthStation Navigation system
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 13 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing posterior cervicothoracic fusions between C2 and upper thoracic will be enrolled.
Who may be able to join
- ≥ 18 years old
- Symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis in the subaxial cervicothoracic spine (between C2-upper thoracic).
- Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
Who cannot join
- Traumatic injury
- Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator
- Severe co-morbidities (e.g., heart, respiratory, or renal disease)
- Clinically diagnosed osteoporosis
- Recent (<3 yrs) or co-incident spinal tumor or infection
- Concurrent involvement in another investigational drug or device study that could confound study data
Show all 10Show fewer
- History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
- Subjects who are pregnant or plan to become pregnant in the next 24 months
- Prisoner
- Other contraindications for Medtronic Infinity System
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
This study is being done to prospectively collect data on subjects having posterior cervical fusion surgery using the Medtronic Infinity system. Researchers plan to collect information from patients having this type of surgery in order to learn more about patient how patients do after the surgery, including the rate of bone healing following surgery.
The goal is for 250 patients to take part in the study or for 500 screws to be used, whichever comes first. Each patient will need a varying amount of screws to be used during their surgery. Because we are measuring the accuracy of each individual screw and the surgeon will likely use multiple screws during each surgery, it is likely that the study will reach its goal of 500 screws before 250 patients are enrolled in the study.
Read the detailed description
This is a prospective single arm study of clinical and radiological outcomes as well as surgical data from posterior cervical fusion for treating degenerative disc disease (DDD). Patients undergoing posterior cervicothoracic fusions between C2 and upper thoracic will be enrolled.
Patients will be enrolled up to 250 patients (at maximum) or 500 screws, whichever is achieved first. This will adequately power the study assuming 95% screw accuracy, which is in line with published data, and assuming precision of +/- 2% with a confidence level of 9%.
The primary objective of this study is to show that the Medtronic Infinity System is safe and effective in posterior cervicothoracic fusion surgeries. Outcomes measures and complication rates will be compared to historical controls. Secondary objectives include screw accuracy rates/revision rates which can also be compared to historical controls. Other secondary objectives aim to clarify the workflow and operative time of using the O-arm and Stealth navigation for these types of cases.
Subjects will be monitored for adverse events throughout the duration of the study, particularly at and around the time of standard of care clinical assessments. The number of CT related adverse events will be evaluated. The monitoring will be performed by the investigator and study clinical research coordinator. The monitoring will occur both when a quarter and a half of the study patients have been enrolled. The study will be stopped should any significant CT related adverse events be identified.
The following data will be collected
Patient demographic and pre-operative clinical information will include:
- Name
- Age
- Sex
- Race (self-reported)
- Vitals
- Height, weight and body mass index (BMI)
- General medical/surgical history
- Medication regimen
- Smoking status (current, former, never)
- History of alcohol/substance abuse
- PROMIS
- Neurological Assessment (strength, sensory, reflexes, Hoffmann's response, Spurling's test)
- Duration of disease
- X-rays, CT, and MRI as available
Patient surgical details to be collected will include:
- Diagnosis
- Date of surgery
- Operative Index levels
- Operative time (incision open to close)
- Implants used
- Length of hospital stay
- Estimated blood loss / Surgical complications
- Somatosensory and motor intraoperative monitoring reports
Post-operative clinical information will include:
- Medication regimen
- PROMIS
- Neurological Assessment (strength, sensory, reflexes, Hoffmann's response, Spurling's test)
- X-rays, CT, and MRI as available
- Conditions
- Degenerative Disc Disease
- Being tested
- Medtronic Infinity Occipitocervical-Upper Thoracic System using the O-arm Imaging System and StealthStation Navigation system
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Infinity Occipitocervical-Upper Thoracic System using the O-arm Imaging System and StealthStation Navigation systemDevice
The INFINITY™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:
- Traumatic spinal fractures and/or traumatic dislocations.
- Instability or deformity.
- Failed previous fusions (e.g. pseudarthrosis).
- Tumors involving the cervical spine.
- Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/ or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Subjects undergoing posterior cervicothoracic fusions between C2 and upper thoracic will be enrolled Receives: Device: Medtronic Infinity Occipitocervical-Upper Thoracic System using the O-arm Imaging System and StealthStation Navigation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Related Adverse Events
All Procedure related adverse events
Measured: 49 Days
Upper and Lower Extremity Motor Exam
MMT Score 1-5 where higher score represents better outcome
Measured: 49 Days
Sensory Function
Sensory Function Score 0-2 where higher score represents better outcome
Measured: 49 Days
Reflexes Score
Reflex Score 0-4 where a score of 2 represents best outcome
Measured: 49 Days
PROMIS - 29 Profile v2.0 Physical Functioning Subscore
Disease non-specific measure of health related physical functioning presented as T-scores with a mean of 50 and standard deviation of 10 with a higher score indicating better outcome
Measured: 49 Days
PROMIS - 29 Profile v2.0 Ability to Participate Subscore
Disease non-specific measure of health related ability to participate presented as T-scores with a mean of 50 and standard deviation of 10 with a higher score indicating better outcome
Measured: 49 Days
PROMIS - 29 Profile v2.0 Anxiety Subscore
Disease non-specific measure of health related anxiety presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
Measured: 49 Days
PROMIS - 29 Profile v2.0 Depression Subscore
Disease non-specific measure of health related depression presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
Measured: 49 Days
PROMIS - 29 Profile v2.0 Fatigue Subscore
Disease non-specific measure of health related fatigue presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
Measured: 49 Days
PROMIS - 29 Profile v2.0 Sleep Subscore
Disease non-specific measure of health related sleep presented as T-scores with a mean of 50 and standard deviation of 10 with a higher score indicating better outcome
Measured: 49 Days
PROMIS - 29 Profile v2.0 Pain Intensity Subscore
Disease non-specific measure of health related pain intensity presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
Measured: 49 Days
Cervical Sagittal Alignment
Cervical Sagittal Alignment measured on pre- and post-operative radiographs
Measured: 49 Days
Hoffmann's Response Test
Hoffmann's Response Test measured as Positive or Negative with negative representing the better outcome
Measured: 49 Days
Spurling's Compression Test
Spurling's Compression Test measured a Positive or Negative with negative representing the better outcome
Measured: 49 Days
All Adverse Events
All Adverse Events and Serious Adverse Events for study duration
Measured: 49 Days
Secondary outcomes (8)
Modified Gerzbein & Robbins Scale
Screw placement accuracy assessed using modified Gertzbein \& Robbins Scale with a score range of 0-4 with lower score indicating better outcome
Measured: 49 Days
Screw Placement Time
Time to place screw
Measured: 49 Days
Screw Intra-op Repositioning Rate
Rate of Screw Repositioning Intraoperatively
Measured: 49 Days
Reference Frame Setup (Level of positioning)
Level of Surgical Positioning
Measured: 49 Days
Perioperative AEs
Rate of Perioperative AEs within 30 days post-op
Measured: 30 Days
OR Time
Time from surgical procedure start to end
Measured: 30 Days
Blood Loss
Blood Loss during surgery measured in cc
Measured: 30 Days
Length of Stay
Length of Hospital Stay measured in days
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Nov 2023
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Andrew Grossbach, Ohio State University
- Investigators
- Andrew Grossbach, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056520
- Sponsor's protocol ID
- 2019H0161
- Status last verified
- Mar 2024
- First submitted
- 23 Jul 2019
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Waschke A, Walter J, Duenisch P, Reichart R, Kalff R, Ewald C. CT-navigation versus fluoroscopy-guided placement of pedicle screws at the thoracolumbar spine: single center experience of 4,500 screws. Eur Spine J. 2013 Mar;22(3):654-60. doi: 10.1007/s00586-012-2509-3. Epub 2012 Sep 23.
PubMed 23001415Silbermann J, Riese F, Allam Y, Reichert T, Koeppert H, Gutberlet M. Computer tomography assessment of pedicle screw placement in lumbar and sacral spine: comparison between free-hand and O-arm based navigation techniques. Eur Spine J. 2011 Jun;20(6):875-81. doi: 10.1007/s00586-010-1683-4. Epub 2011 Jan 21.
PubMed 21253780Luther N, Iorgulescu JB, Geannette C, Gebhard H, Saleh T, Tsiouris AJ, Hartl R. Comparison of navigated versus non-navigated pedicle screw placement in 260 patients and 1434 screws: screw accuracy, screw size, and the complexity of surgery. J Spinal Disord Tech. 2015 Jun;28(5):E298-303. doi: 10.1097/BSD.0b013e31828af33e.
PubMed 23511642Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990 Jan;15(1):11-4. doi: 10.1097/00007632-199001000-00004.
PubMed 2326693
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Outcomes of Posterior Cervical Fusion with Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
- ClinicalTrials.gov ID
- NCT04056520
- Acronym / sponsor ID
- 2019H0161
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 14 Aug 2019 (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 study is being done to prospectively collect data on subjects having posterior cervical fusion surgery using the Medtronic Infinity system. Researchers plan to collect information from patients having this type of surgery in order to learn more about patient how patients do after the surgery, including the rate of bone healing following surgery.
The goal is for 250 patients to take part in the study or for 500 screws to be used, whichever comes first. Each patient will need a varying amount of screws to be used during their surgery. Because we are measuring the accuracy of each individual screw and the surgeon will likely use multiple screws during each surgery, it is likely that the study will reach its goal of 500 screws before 250 patients are enrolled in the study.
Detailed description
This is a prospective single arm study of clinical and radiological outcomes as well as surgical data from posterior cervical fusion for treating degenerative disc disease (DDD). Patients undergoing posterior cervicothoracic fusions between C2 and upper thoracic will be enrolled.
Patients will be enrolled up to 250 patients (at maximum) or 500 screws, whichever is achieved first. This will adequately power the study assuming 95% screw accuracy, which is in line with published data, and assuming precision of +/- 2% with a confidence level of 9%.
The primary objective of this study is to show that the Medtronic Infinity System is safe and effective in posterior cervicothoracic fusion surgeries. Outcomes measures and complication rates will be compared to historical controls. Secondary objectives include screw accuracy rates/revision rates which can also be compared to historical controls. Other secondary objectives aim to clarify the workflow and operative time of using the O-arm and Stealth navigation for these types of cases.
Subjects will be monitored for adverse events throughout the duration of the study, particularly at and around the time of standard of care clinical assessments. The number of CT related adverse events will be evaluated. The monitoring will be performed by the investigator and study clinical research coordinator. The monitoring will occur both when a quarter and a half of the study patients have been enrolled. The study will be stopped should any significant CT related adverse events be identified.
The following data will be collected
Patient demographic and pre-operative clinical information will include:
- Name
- Age
- Sex
- Race (self-reported)
- Vitals
- Height, weight and body mass index (BMI)
- General medical/surgical history
- Medication regimen
- Smoking status (current, former, never)
- History of alcohol/substance abuse
- PROMIS
- Neurological Assessment (strength, sensory, reflexes, Hoffmann's response, Spurling's test)
- Duration of disease
- X-rays, CT, and MRI as available
Patient surgical details to be collected will include:
- Diagnosis
- Date of surgery
- Operative Index levels
- Operative time (incision open to close)
- Implants used
- Length of hospital stay
- Estimated blood loss / Surgical complications
- Somatosensory and motor intraoperative monitoring reports
Post-operative clinical information will include:
- Medication regimen
- PROMIS
- Neurological Assessment (strength, sensory, reflexes, Hoffmann's response, Spurling's test)
- X-rays, CT, and MRI as available
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Device: Medtronic Infinity Occipitocervical-Upper Thoracic System using the O-arm Imaging System and StealthStation Navigation systemSubjects undergoing posterior cervicothoracic fusions between C2 and upper thoracic will be enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing posterior cervicothoracic fusions between C2 and upper thoracic will be enrolled.
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis in the subaxial cervicothoracic spine (between C2-upper thoracic).
- Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
Key exclusion criteria (10 listed)
- Traumatic injury
- Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator
- Severe co-morbidities (e.g., heart, respiratory, or renal disease)
- Clinically diagnosed osteoporosis
- Recent (<3 yrs) or co-incident spinal tumor or infection
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 |
|---|---|---|
| Medtronic Infinity Occipitocervical-Upper Thoracic System using the O-arm Imaging System and StealthStation Navigation systemThe INFINITY™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: * Traumatic spinal fractures and/or traumatic dislocations. * Instability or deformity. * Failed previous fusions (e.g. pseudarthrosis). * Tumors involving the cervical spine. * Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/ or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. | Device | Arm 1 |
Primary outcome
Related Adverse Events
Time frame: 49 Days
All Procedure related adverse events
Upper and Lower Extremity Motor Exam
Time frame: 49 Days
MMT Score 1-5 where higher score represents better outcome
Sensory Function
Time frame: 49 Days
Sensory Function Score 0-2 where higher score represents better outcome
Reflexes Score
Time frame: 49 Days
Reflex Score 0-4 where a score of 2 represents best outcome
PROMIS - 29 Profile v2.0 Physical Functioning Subscore
Time frame: 49 Days
Disease non-specific measure of health related physical functioning presented as T-scores with a mean of 50 and standard deviation of 10 with a higher score indicating better outcome
PROMIS - 29 Profile v2.0 Ability to Participate Subscore
Time frame: 49 Days
Disease non-specific measure of health related ability to participate presented as T-scores with a mean of 50 and standard deviation of 10 with a higher score indicating better outcome
PROMIS - 29 Profile v2.0 Anxiety Subscore
Time frame: 49 Days
Disease non-specific measure of health related anxiety presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
PROMIS - 29 Profile v2.0 Depression Subscore
Time frame: 49 Days
Disease non-specific measure of health related depression presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
PROMIS - 29 Profile v2.0 Fatigue Subscore
Time frame: 49 Days
Disease non-specific measure of health related fatigue presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
PROMIS - 29 Profile v2.0 Sleep Subscore
Time frame: 49 Days
Disease non-specific measure of health related sleep presented as T-scores with a mean of 50 and standard deviation of 10 with a higher score indicating better outcome
PROMIS - 29 Profile v2.0 Pain Intensity Subscore
Time frame: 49 Days
Disease non-specific measure of health related pain intensity presented as T-scores with a mean of 50 and standard deviation of 10 with a lower score indicating better outcome
Cervical Sagittal Alignment
Time frame: 49 Days
Cervical Sagittal Alignment measured on pre- and post-operative radiographs
Hoffmann's Response Test
Time frame: 49 Days
Hoffmann's Response Test measured as Positive or Negative with negative representing the better outcome
Spurling's Compression Test
Time frame: 49 Days
Spurling's Compression Test measured a Positive or Negative with negative representing the better outcome
All Adverse Events
Time frame: 49 Days
All Adverse Events and Serious Adverse Events for study duration
8 secondary outcomes
Modified Gerzbein & Robbins Scale
Time frame: 49 Days
Screw Placement Time
Time frame: 49 Days
Screw Intra-op Repositioning Rate
Time frame: 49 Days
Reference Frame Setup (Level of positioning)
Time frame: 49 Days
Perioperative AEs
Time frame: 30 Days
OR Time
Time frame: 30 Days
Blood Loss
Time frame: 30 Days
Length of Stay
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Background: PubMed 23001415Waschke A, Walter J, Duenisch P, Reichart R, Kalff R, Ewald C. CT-navigation versus fluoroscopy-guided placement of pedicle screws at the thoracolumbar spine: single center experience of 4,500 screws. Eur Spine J. 2013 Mar;22(3):654-60. doi: 10.1007/s00586-012-2509-3. Epub 2012 Sep 23.
- Background: PubMed 21253780Silbermann J, Riese F, Allam Y, Reichert T, Koeppert H, Gutberlet M. Computer tomography assessment of pedicle screw placement in lumbar and sacral spine: comparison between free-hand and O-arm based navigation techniques. Eur Spine J. 2011 Jun;20(6):875-81. doi: 10.1007/s00586-010-1683-4. Epub 2011 Jan 21.
- Background: PubMed 23511642Luther N, Iorgulescu JB, Geannette C, Gebhard H, Saleh T, Tsiouris AJ, Hartl R. Comparison of navigated versus non-navigated pedicle screw placement in 260 patients and 1434 screws: screw accuracy, screw size, and the complexity of surgery. J Spinal Disord Tech. 2015 Jun;28(5):E298-303. doi: 10.1097/BSD.0b013e31828af33e.
- Background: PubMed 2326693Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990 Jan;15(1):11-4. doi: 10.1097/00007632-199001000-00004.
- 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.
Andrew Grossbach, MD principal investigator
Ohio State University
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 Degenerative Disc Disease, run by Ohio State University at 1 site 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Related Adverse Events (time frame: 49 Days). The study lists 15 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 NCT04056520, which also lists 4 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 Mar 2025.