Fused VertebraeNCT04125147
Clinical Investigation of MONTAGE in Adults With Spinal Deformity Undergoing Pedicle Subtraction Osteotomy
A study testing Experimental: Montage Bone Hemostat in people with Fused Vertebrae and Ankylosing Spondylitis, run by Abyrx, Inc. at 1 site in United States.
Trial summary
This study evaluates the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE Settable Resorbable Hemostatic Bone Putty and standard of care (no bone hemostat) during pedicle subtraction osteotomy procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fused Vertebrae, Ankylosing Spondylitis, Sagittal Deformities
- What is being tested?
- Experimental: Montage Bone Hemostat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2019to 20 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of spinal deformity requiring a PSO at a single site level, such as for patients with thoracolumbar kyphotic deformity, sagittal imbalance, and spinal global malalignment.
- Non-smokers (have proven to quit smoking for at least 6 months prior to surgery) and current smokers.
- Female subjects of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). A pregnancy test at the Week 0 visit must be administered, and must be negative, for inclusion into the study.
- Subject understands and is willing to participate in the clinical study and can comply with required visits and the follow-up regimen.
- Subject has read and signed the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form before screening procedures are undertaken.
Who cannot join
- Subjects whose spinal deformity is deemed by the investigator to be of such severity that a possible surgical intervention would be either harmful or not warranted.
- Subjects with morbid obesity (i.e. a Body Mass Index [BMI] ≥ 40).
- Subjects who have a known allergy to the components of MONTAGE.
- Subjects who are non-mobile (i.e. not ambulatory, or have significant impairment of their mobility making them completely bedridden).
- Subjects who, in the opinion of the investigator, show evidence of infection, cellulitis, and/or osteomyelitis.
- Subjects with abnormally low platelets, abnormal coagulation parameters, or with documented bleeding disorders, including a prior history of excessive bleeding during surgery.
Show all 15Show fewer
- Subjects with a history of a malignancy, not in remission for five years or more, or a newly diagnosed malignancy, treated with cytotoxic therapies or radiation therapy.
- Subjects on any investigational drug(s) within 30 days preceding randomization (i.e. Week 0); or subject or physician anticipates use of any of these therapies by the subject during the course of the study.
- Subjects with:
- Alcohol abuse as recorded by an average daily intake of > 4 units in females, > 5 units in males (i.e. 1 oz. of spirit, glass of wine, or can of beer per unit).
- Drug abuse as evidenced by the subject's use of illegal drugs or prescription drugs that have not been prescribed for him/her.
- Subjects with one or more medical conditions, as determined by medical history, including renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this study.
- Subjects with a history of osteoporosis, as defined by imaging, or on medication for osteoporosis or documented fracture of fragility (Hip fracture, osteoporotic compression fracture, distal radius fracture). If there are any concerns these may be arbitrated by the study PI.
- Subject has previously participated in any MONTAGE trial.
- Subjects who are unable to understand the aims and objectives of the trial and/or unwilling to return for the follow-up examinations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Clinical Investigation of MONTAGE in Adults With Spinal Deformity Undergoing Pedicle Subtraction Osteotomy
This study evaluates the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE Settable Resorbable Hemostatic Bone Putty and standard of care (no bone hemostat) during pedicle subtraction osteotomy procedures.
Read the detailed description
Pedicle Subtraction osteotomy (PSO) is a surgical option for treating several spinal deformities. It has been utilized in alignment disorders of the fused spine, in the lumbar spine to treat large sagittal deformities and in patients with ankylosing spondylitis with thoracolumbar kyphotic deformity.
PSO typically results in substantial loss of blood (as much as 2L) with a significant portion of the loss likely occurring at the osteotomy surfaces post-surgically. The control of peri-operative blood loss is considered a critical issue by spine surgeons. A variety of methods have been proposed for the reduction of blood loss during or immediately after spine surgery, including preoperative use of erythropoietin, autologous blood, cell salvage, intra-operative controlled hypotension, and the use of anti-fibrinolytic drugs. Bone hemostats have traditionally not been part of the standard of care to promote hemostasis probably because most traditional options (e.g., bone wax) are nonabsorbable and thus might interfere with fusion at the osteotomy site.
MONTAGE is a settable (hardening) bioabsorbable polymer and hydroxyapatite/beta tricalcium phosphate based putty, used in the control of bleeding from bone during spine, orthopedic, craniomaxillofacial, thoracic and other surgical procedures, and has been FDA cleared.
- Being tested
- Experimental: Montage Bone Hemostat
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Montage Bone HemostatDevice
Use of Montage bone hemostat on the cut surfaces of bone at the osteotomy site
| Study group | Role | What they receive |
|---|---|---|
| Montage Bone Hemostat | Experimental | Use of Montage Settable Resorbable Hemostatic bone putty on the cut surfaces of bleeding bone at the osteotomy site Receives: Device: Experimental: Montage Bone Hemostat |
| Standard of Care: No bone hemostat | No intervention | Use of no bone hemostat on the cut surfaces of bleeding bone at the osteotomy site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis
The primary objective of this study is to evaluate the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE and standard of care (no bone hemostat), and the extent to which any transfusion is needed.
Measured: Week 0
Hemostasis
The primary objective of this study is to evaluate the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE and standard of care (no bone hemostat), with blood loss is measured through drop in hematocrit (HCT).
Measured: Week 0
Hemostasis
The primary objective of this study is to evaluate the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE and standard of care (no bone hemostat) as wound drain output, if utilized.
Measured: Week 0
Secondary outcomes (1)
PSO Stability
The secondary objective is the stability of the construct, as measured by whether the correction has maintained stability at 1-year and 2-years post surgery. Each incidence of instability will be categorized as belonging to one of the following groups: 1) hardware malplacement, 2) loosening or dislodgement, 3) nonunion or nonfusion with hardware fracture 4) nonunion or nonfusion without hardware fracture and 5) perihardware fracture.
Measured: 1-year and 2-years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start5 Dec 2019
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Fused VertebraeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abyrx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Lavelle, MD, Principal investigator, SUNY Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125147
- Sponsor's protocol ID
- 20182341
- Status last verified
- Jul 2023
- First submitted
- 9 Oct 2019
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Cogniet A, Aunoble S, Rigal J, Demezon H, Sadikki R, Le Huec JC. Clinical and radiological outcomes of lumbar posterior subtraction osteotomies are correlated to pelvic incidence and FBI index : Prospective series of 63 cases. Eur Spine J. 2016 Aug;25(8):2657-67. doi: 10.1007/s00586-016-4424-5. Epub 2016 Feb 10.
PubMed 26861730Liu H, Yang C, Zheng Z, Ding W, Wang J, Wang H, Li S. Comparison of Smith-Petersen osteotomy and pedicle subtraction osteotomy for the correction of thoracolumbar kyphotic deformity in ankylosing spondylitis: a systematic review and meta-analysis. Spine (Phila Pa 1976). 2015 Apr 15;40(8):570-9. doi: 10.1097/BRS.0000000000000815.
PubMed 25868095Bridwell KH. Decision making regarding Smith-Petersen vs. pedicle subtraction osteotomy vs. vertebral column resection for spinal deformity. Spine (Phila Pa 1976). 2006 Sep 1;31(19 Suppl):S171-8. doi: 10.1097/01.brs.0000231963.72810.38.
PubMed 16946635Bridwell KH, Lewis SJ, Lenke LG, Baldus C, Blanke K. Pedicle subtraction osteotomy for the treatment of fixed sagittal imbalance. J Bone Joint Surg Am. 2003 Mar;85(3):454-63. doi: 10.2106/00004623-200303000-00009.
PubMed 12637431Hyun SJ, Kim YJ, Rhim SC. Spinal pedicle subtraction osteotomy for fixed sagittal imbalance patients. World J Clin Cases. 2013 Nov 16;1(8):242-8. doi: 10.12998/wjcc.v1.i8.242.
PubMed 24340276Lee EI, Chao AH, Skoracki RJ, Yu P, DeMonte F, Hanasono MM. Outcomes of calvarial reconstruction in cancer patients. Plast Reconstr Surg. 2014 Mar;133(3):675-682. doi: 10.1097/01.prs.0000438061.46290.33.
PubMed 24263391Cheng L, Ye F, Yang R, Lu X, Shi Y, Li L, Fan H, Bu H. Osteoinduction of hydroxyapatite/beta-tricalcium phosphate bioceramics in mice with a fractured fibula. Acta Biomater. 2010 Apr;6(4):1569-74. doi: 10.1016/j.actbio.2009.10.050. Epub 2009 Nov 5.
PubMed 19896564Pripatnanont P, Praserttham P, Suttapreyasri S, Leepong N, Monmaturapoj N. Bone Regeneration Potential of Biphasic Nanocalcium Phosphate with High Hydroxyapatite/Tricalcium Phosphate Ratios in Rabbit Calvarial Defects. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):294-303. doi: 10.11607/jomi.4531.
PubMed 27004276Koshiyama H, Yamazaki K. Absorbable sternal pins improve sternal closure stability within a small deviation. Gen Thorac Cardiovasc Surg. 2015 Jun;63(6):331-4. doi: 10.1007/s11748-015-0533-z. Epub 2015 Feb 27.
PubMed 25720972Baumgart D, Herbon G, Borowski A, de Vivie ER. Primary closure of median sternotomy with interposition of hydroxyapatite blocks. A new approach in pediatric cardiac surgery. Eur J Cardiothorac Surg. 1991;5(7):383-5. doi: 10.1016/1010-7940(91)90057-q.
PubMed 1832549Barbanti Brodano G, Griffoni C, Zanotti B, Gasbarrini A, Bandiera S, Ghermandi R, Boriani S. A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion. Eur Rev Med Pharmacol Sci. 2015 Oct;19(19):3548-55.
PubMed 26502842Yi S, Rim DC, Park SW, Murovic JA, Lim J, Park J. Biomechanical Comparisons of Pull Out Strengths After Pedicle Screw Augmentation with Hydroxyapatite, Calcium Phosphate, or Polymethylmethacrylate in the Cadaveric Spine. World Neurosurg. 2015 Jun;83(6):976-81. doi: 10.1016/j.wneu.2015.01.056. Epub 2015 Mar 10.
PubMed 25769482
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled Clinical Investigation of MONTAGE in Adults With Spinal Deformity Undergoing Pedicle Subtraction Osteotomy
- ClinicalTrials.gov ID
- NCT04125147
- Acronym / sponsor ID
- 20182341
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Abyrx, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 14 Oct 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 evaluates the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE Settable Resorbable Hemostatic Bone Putty and standard of care (no bone hemostat) during pedicle subtraction osteotomy procedures.
Detailed description
Pedicle Subtraction osteotomy (PSO) is a surgical option for treating several spinal deformities. It has been utilized in alignment disorders of the fused spine, in the lumbar spine to treat large sagittal deformities and in patients with ankylosing spondylitis with thoracolumbar kyphotic deformity.
PSO typically results in substantial loss of blood (as much as 2L) with a significant portion of the loss likely occurring at the osteotomy surfaces post-surgically. The control of peri-operative blood loss is considered a critical issue by spine surgeons. A variety of methods have been proposed for the reduction of blood loss during or immediately after spine surgery, including preoperative use of erythropoietin, autologous blood, cell salvage, intra-operative controlled hypotension, and the use of anti-fibrinolytic drugs. Bone hemostats have traditionally not been part of the standard of care to promote hemostasis probably because most traditional options (e.g., bone wax) are nonabsorbable and thus might interfere with fusion at the osteotomy site.
MONTAGE is a settable (hardening) bioabsorbable polymer and hydroxyapatite/beta tricalcium phosphate based putty, used in the control of bleeding from bone during spine, orthopedic, craniomaxillofacial, thoracic and other surgical procedures, and has been FDA cleared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montage Bone Hemostat | Experimental | Device: Experimental: Montage Bone HemostatUse of Montage Settable Resorbable Hemostatic bone putty on the cut surfaces of bleeding bone at the osteotomy site |
| Standard of Care: No bone hemostat | No intervention | –Use of no bone hemostat on the cut surfaces of bleeding bone at the osteotomy site |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of spinal deformity requiring a PSO at a single site level, such as for patients with thoracolumbar kyphotic deformity, sagittal imbalance, and spinal global malalignment.
- Non-smokers (have proven to quit smoking for at least 6 months prior to surgery) and current smokers.
- Female subjects of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). A pregnancy test at the Week 0 visit must be administered, and must be negative, for inclusion into the study.
- Subject understands and is willing to participate in the clinical study and can comply with required visits and the follow-up regimen.
- Subject has read and signed the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form before screening procedures are undertaken.
Key exclusion criteria (15 listed)
- Subjects whose spinal deformity is deemed by the investigator to be of such severity that a possible surgical intervention would be either harmful or not warranted.
- Subjects with morbid obesity (i.e. a Body Mass Index [BMI] ≥ 40).
- Subjects who have a known allergy to the components of MONTAGE.
- Subjects who are non-mobile (i.e. not ambulatory, or have significant impairment of their mobility making them completely bedridden).
- Subjects who, in the opinion of the investigator, show evidence of infection, cellulitis, and/or osteomyelitis.
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: Montage Bone HemostatUse of Montage bone hemostat on the cut surfaces of bone at the osteotomy site | Device | Montage Bone Hemostat |
Primary outcome
Hemostasis
Time frame: Week 0
The primary objective of this study is to evaluate the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE and standard of care (no bone hemostat), and the extent to which any transfusion is needed.
Hemostasis
Time frame: Week 0
The primary objective of this study is to evaluate the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE and standard of care (no bone hemostat), with blood loss is measured through drop in hematocrit (HCT).
Hemostasis
Time frame: Week 0
The primary objective of this study is to evaluate the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE and standard of care (no bone hemostat) as wound drain output, if utilized.
1 secondary outcome
PSO Stability
Time frame: 1-year and 2-years post surgery
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 26861730Cogniet A, Aunoble S, Rigal J, Demezon H, Sadikki R, Le Huec JC. Clinical and radiological outcomes of lumbar posterior subtraction osteotomies are correlated to pelvic incidence and FBI index : Prospective series of 63 cases. Eur Spine J. 2016 Aug;25(8):2657-67. doi: 10.1007/s00586-016-4424-5. Epub 2016 Feb 10.
- Background: PubMed 25868095Liu H, Yang C, Zheng Z, Ding W, Wang J, Wang H, Li S. Comparison of Smith-Petersen osteotomy and pedicle subtraction osteotomy for the correction of thoracolumbar kyphotic deformity in ankylosing spondylitis: a systematic review and meta-analysis. Spine (Phila Pa 1976). 2015 Apr 15;40(8):570-9. doi: 10.1097/BRS.0000000000000815.
- Background: PubMed 16946635Bridwell KH. Decision making regarding Smith-Petersen vs. pedicle subtraction osteotomy vs. vertebral column resection for spinal deformity. Spine (Phila Pa 1976). 2006 Sep 1;31(19 Suppl):S171-8. doi: 10.1097/01.brs.0000231963.72810.38.
- Background: PubMed 12637431Bridwell KH, Lewis SJ, Lenke LG, Baldus C, Blanke K. Pedicle subtraction osteotomy for the treatment of fixed sagittal imbalance. J Bone Joint Surg Am. 2003 Mar;85(3):454-63. doi: 10.2106/00004623-200303000-00009.
- Background: PubMed 24340276Hyun SJ, Kim YJ, Rhim SC. Spinal pedicle subtraction osteotomy for fixed sagittal imbalance patients. World J Clin Cases. 2013 Nov 16;1(8):242-8. doi: 10.12998/wjcc.v1.i8.242.
- Background: PubMed 24263391Lee EI, Chao AH, Skoracki RJ, Yu P, DeMonte F, Hanasono MM. Outcomes of calvarial reconstruction in cancer patients. Plast Reconstr Surg. 2014 Mar;133(3):675-682. doi: 10.1097/01.prs.0000438061.46290.33.
- Background: PubMed 19896564Cheng L, Ye F, Yang R, Lu X, Shi Y, Li L, Fan H, Bu H. Osteoinduction of hydroxyapatite/beta-tricalcium phosphate bioceramics in mice with a fractured fibula. Acta Biomater. 2010 Apr;6(4):1569-74. doi: 10.1016/j.actbio.2009.10.050. Epub 2009 Nov 5.
- Background: PubMed 27004276Pripatnanont P, Praserttham P, Suttapreyasri S, Leepong N, Monmaturapoj N. Bone Regeneration Potential of Biphasic Nanocalcium Phosphate with High Hydroxyapatite/Tricalcium Phosphate Ratios in Rabbit Calvarial Defects. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):294-303. doi: 10.11607/jomi.4531.
- Background: PubMed 25720972Koshiyama H, Yamazaki K. Absorbable sternal pins improve sternal closure stability within a small deviation. Gen Thorac Cardiovasc Surg. 2015 Jun;63(6):331-4. doi: 10.1007/s11748-015-0533-z. Epub 2015 Feb 27.
- Background: PubMed 1832549Baumgart D, Herbon G, Borowski A, de Vivie ER. Primary closure of median sternotomy with interposition of hydroxyapatite blocks. A new approach in pediatric cardiac surgery. Eur J Cardiothorac Surg. 1991;5(7):383-5. doi: 10.1016/1010-7940(91)90057-q.
- Background: PubMed 26502842Barbanti Brodano G, Griffoni C, Zanotti B, Gasbarrini A, Bandiera S, Ghermandi R, Boriani S. A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion. Eur Rev Med Pharmacol Sci. 2015 Oct;19(19):3548-55.
- Background: PubMed 25769482Yi S, Rim DC, Park SW, Murovic JA, Lim J, Park J. Biomechanical Comparisons of Pull Out Strengths After Pedicle Screw Augmentation with Hydroxyapatite, Calcium Phosphate, or Polymethylmethacrylate in the Cadaveric Spine. World Neurosurg. 2015 Jun;83(6):976-81. doi: 10.1016/j.wneu.2015.01.056. Epub 2015 Mar 10.
- Individual participant dataSharing planned: Undecided
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.
William Lavelle, MD principal investigator
SUNY Upstate
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: Montage Bone Hemostat in people with Fused Vertebrae and Ankylosing Spondylitis, run by Abyrx, Inc. 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 1 Aug 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 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 was stopped early (reason given: Low enrollment). 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?
Hemostasis (time frame: Week 0). The study lists 3 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 NCT04125147, which also lists 12 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 1 Aug 2023.