RSD (Reflex Sympathetic Dystrophy)Phase 1/2ADcSVF-CRPSNCT02987855
Adipose Stem/Stromal Cells in RSD, CRPS, Fibromyalgia
A Phase 1/2 study testing Lipoaspiration, ADcSVF isolation and Normal Saline IV in people with RSD (Reflex Sympathetic Dystrophy) and CRPS - Complex Regional Pain Syndrome Type I, run by Healeon Medical Inc at 2 sites in 2 countries.
Trial summary
Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), Causalgia, and Fibromyalgia represent progressive systemic pain conditions which often worsen over time. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- RSD (Reflex Sympathetic Dystrophy), CRPS - Complex Regional Pain Syndrome Type I, Fibromyalgia
- What is being tested?
- Lipoaspiration, ADcSVF isolation and Normal Saline IV
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Dec 2018to Jun 2024
- Phase
- Phase 1/2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with confirmed diagnosis of RSD, CRPS, and severe Fibromyalgia
- Ability to provide Informed Consent (or as parent or legal guardian)
Who cannot join
- Patients with severe comorbidities which, in opinion of PI or provider associates. would be unsafe or not advised to be able to comply with study or follow up requirements
- Patients with documented Opiate abuse
- Patient taking corticosteroid therapy, immune suppression, or chemotherapeutic regimen within 6 months of entry
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), and Fibromyalgia
Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), Causalgia, and Fibromyalgia represent progressive systemic pain conditions which often worsen over time. They appear to be dysregulation of the central nervous system (CNS) and the autonomic system (sympathetic/parasympathetic) which cause extensive functional losses, impairment, and disabilities. They are often associated with injury sites (including surgical) which produce constant, often disabling pain and motor-sensory losses.
Treatments are often ineffective and include medications (often high dose opiates), Physical Therapy (PT), and surgical interventions (sympathectomy, ablation) or insertion stimulators of the CNS.
Study is an interventional study to document the safety and efficacy of use of adipose-derived cellular stromal vascular fraction (AD-cSVF) in chronic pain and dysfunction disease groups.
Read the detailed description
Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), Causalgia, and Fibromyalgia represent progressive systemic pain conditions which often worsen over time. They appear to be dysregulation of the central nervous system (CNS) and the autonomic system (sympathetic/parasympathetic) which cause extensive functional losses, impairment, and disabilities. They are often associated with injury sites (including surgical) which produce constant, often disabling pain and motor-sensory losses.
Treatments are often ineffective and include medications (often high dose opiates), physical therapy (PT(, and surgical interventions (sympathectomy, ablation) or insertion stimulators of the CNS.
Clinical Features include neurogenic inflammation, nociceptive sensitization, vasomotor dysfunction and maladaptive neuroplasticity. As these often seem related to specific injury sites (trauma, surgical, etc.) which are followed with severe pain sensations such as stabbing, burning, throbbing, and local muscular spasms or hemiparesis. In addition, there are many reports of visual change, dropping attacks (sudden falling), joint soreness, and other systemic symptoms associated with potentially any organ in the body.
Diagnosis typically recognizes 3 distinct "types" which do not appear to be sequential in nature. Type 1 characterization is severe, burning sensory change near an injury site, musculoskeletal and joint stiffness. Type 2 demonstrates very high pain levels, swelling, muscular atrophy, joint degeneration, depression, and other concomitant dysfunctions. Type 3 features irreversible changes to skin/bone, and extreme loss of function of muscle (atrophic primarily) and tendons. A significant percentage (13-70 ) are felt to be at risk if neurological injuries, hemiplegia, enhanced vasomotor issues due to enhanced sympathetic actions and neurotransmission issues.
This study includes microcannula harvesting of subdermal adipose tissues, incubation, digestion and isolation of AD-cSVF. This stromal cellular pellet (without actual extracellular matrix or stromal elements) is then suspended in 500 cc sterile Normal Saline (NS) and deployed via peripheral intravenous route. Evaluations of safety issues are measured at intervals (both severe and non-severe categories) and by repeated pulmonary function studies.
- Conditions
- RSD (Reflex Sympathetic Dystrophy), CRPS - Complex Regional Pain Syndrome Type I, Fibromyalgia
- Being tested
- Lipoaspiration, ADcSVF isolation, Normal Saline IV
- Medical subject headings
- Complex Regional Pain Syndromes, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoaspirationProcedure or surgery
Closed syringe harvesting subdermal fat
ADcSVF isolationProcedure or surgery
Isolation of AD-cSVF from lipoaspirate via enzymatic digestion
Normal Saline IVProcedure or surgery
Normal Saline IV containing autologous AD-cSVF
| Study group | Role | What they receive |
|---|---|---|
| Lipoaspiration Arm 1 | Experimental | Acquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe lipoaspiration harvest of subdermal fat Receives: Procedure: Lipoaspiration |
| AD-cSVF Arm 2 | Experimental | ADcSVF Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction Receives: Procedure: ADcSVF isolation |
| Normal Saline IV Arm 3 | Experimental | Normal Saline IV with AD-cSVF cells Receives: Procedure: Normal Saline IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse and Severe Adverse Reaction Report
Evaluate any Adverse or Severe Adverse Reactions
Measured: 12 months
Secondary outcomes (3)
Change from Baseline Pain Levels
Pain Scale Questionnaire 1-10
Measured: 1 month, 6 month, 1 year
Change in Quality of Life from Baseline
Quality of Life Questionnaire (QoL)
Measured: 6 months, 12 months
Change from Baseline of Lifestyle
Fibromyalgia Impact Questionnaire (FIQR)
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start15 Dec 2018
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: Withdrawn \[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for RSD (Reflex Sympathetic Dystrophy)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healeon Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Robert W. Alexander, MD, FICS, Healeon Medical Inc
- Investigators
- Glenn C Terry, MD, Principal investigator, Global Alliance for Regenerative Medicine (GARM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987855
- Sponsor's protocol ID
- RSD-CRPS
- Acronym
- ADcSVF-CRPS
- Status last verified
- Feb 2021
- First submitted
- 5 Dec 2016
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwartzman RJ, Erwin KL, Alexander GM. The natural history of complex regional pain syndrome. Clin J Pain. 2009 May;25(4):273-80. doi: 10.1097/AJP.0b013e31818ecea5.
PubMed 19590474Marinus J, Moseley GL, Birklein F, Baron R, Maihofner C, Kingery WS, van Hilten JJ. Clinical features and pathophysiology of complex regional pain syndrome. Lancet Neurol. 2011 Jul;10(7):637-48. doi: 10.1016/S1474-4422(11)70106-5.
PubMed 21683929Veldman PH, Reynen HM, Arntz IE, Goris RJ. Signs and symptoms of reflex sympathetic dystrophy: prospective study of 829 patients. Lancet. 1993 Oct 23;342(8878):1012-6. doi: 10.1016/0140-6736(93)92877-v.
PubMed 8105263Maihofner C, Forster C, Birklein F, Neundorfer B, Handwerker HO. Brain processing during mechanical hyperalgesia in complex regional pain syndrome: a functional MRI study. Pain. 2005 Mar;114(1-2):93-103. doi: 10.1016/j.pain.2004.12.001. Epub 2005 Jan 26.
PubMed 15733635Watkins LR, Maier SF. Immune regulation of central nervous system functions: from sickness responses to pathological pain. J Intern Med. 2005 Feb;257(2):139-55. doi: 10.1111/j.1365-2796.2004.01443.x.
PubMed 15656873Birklein F. Complex regional pain syndrome. J Neurol. 2005 Feb;252(2):131-8. doi: 10.1007/s00415-005-0737-8.
PubMed 15729516Lee BH, Scharff L, Sethna NF, McCarthy CF, Scott-Sutherland J, Shea AM, Sullivan P, Meier P, Zurakowski D, Masek BJ, Berde CB. Physical therapy and cognitive-behavioral treatment for complex regional pain syndromes. J Pediatr. 2002 Jul;141(1):135-40. doi: 10.1067/mpd.2002.124380.
PubMed 12091866van de Meent H, Oerlemans M, Bruggeman A, Klomp F, van Dongen R, Oostendorp R, Frolke JP. Safety of "pain exposure" physical therapy in patients with complex regional pain syndrome type 1. Pain. 2011 Jun;152(6):1431-1438. doi: 10.1016/j.pain.2011.02.032. Epub 2011 Apr 6.
PubMed 21474244Swart CM, Stins JF, Beek PJ. Cortical changes in complex regional pain syndrome (CRPS). Eur J Pain. 2009 Oct;13(9):902-7. doi: 10.1016/j.ejpain.2008.11.010. Epub 2008 Dec 19.
PubMed 19101181Chopra P, Cooper MS. Treatment of Complex Regional Pain Syndrome (CRPS) using low dose naltrexone (LDN). J Neuroimmune Pharmacol. 2013 Jun;8(3):470-6. doi: 10.1007/s11481-013-9451-y. Epub 2013 Apr 2.
PubMed 23546884Azari P, Lindsay DR, Briones D, Clarke C, Buchheit T, Pyati S. Efficacy and safety of ketamine in patients with complex regional pain syndrome: a systematic review. CNS Drugs. 2012 Mar 1;26(3):215-28. doi: 10.2165/11595200-000000000-00000.
PubMed 22136149Opal SM, Wiest PM, Olds GR. Traveler's diarrhea: methods of prevention and treatment. R I Med J (1976). 1990 May;73(5):199-204.
PubMed 2343234Varenna M, Adami S, Rossini M, Gatti D, Idolazzi L, Zucchi F, Malavolta N, Sinigaglia L. Treatment of complex regional pain syndrome type I with neridronate: a randomized, double-blind, placebo-controlled study. Rheumatology (Oxford). 2013 Mar;52(3):534-42. doi: 10.1093/rheumatology/kes312. Epub 2012 Nov 30.
PubMed 23204550Gainer MJ. Hypnotherapy for reflex sympathetic dystrophy. Am J Clin Hypn. 1992 Apr;34(4):227-32. doi: 10.1080/00029157.1992.10402852.
PubMed 1349789Hamdi TN. The Copeland intraocular lens: five to ten years later. Ophthalmology. 1979 Jun;86(6):984-96. doi: 10.1016/s0161-6420(79)35409-4.
PubMed 534104
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), and Fibromyalgia
- ClinicalTrials.gov ID
- NCT02987855
- Acronym / sponsor ID
- ADcSVF-CRPS / RSD-CRPS
- Conditions
- RSD (Reflex Sympathetic Dystrophy), CRPS - Complex Regional Pain Syndrome Type I, Fibromyalgia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn \[COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform\]
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Healeon Medical IncIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- 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.
Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), Causalgia, and Fibromyalgia represent progressive systemic pain conditions which often worsen over time. They appear to be dysregulation of the central nervous system (CNS) and the autonomic system (sympathetic/parasympathetic) which cause extensive functional losses, impairment, and disabilities. They are often associated with injury sites (including surgical) which produce constant, often disabling pain and motor-sensory losses.
Treatments are often ineffective and include medications (often high dose opiates), Physical Therapy (PT), and surgical interventions (sympathectomy, ablation) or insertion stimulators of the CNS.
Study is an interventional study to document the safety and efficacy of use of adipose-derived cellular stromal vascular fraction (AD-cSVF) in chronic pain and dysfunction disease groups.
Detailed description
Reflex Sympathetic Dystrophy (RSD), Complex Regional Pain Syndrome (CRPS), Causalgia, and Fibromyalgia represent progressive systemic pain conditions which often worsen over time. They appear to be dysregulation of the central nervous system (CNS) and the autonomic system (sympathetic/parasympathetic) which cause extensive functional losses, impairment, and disabilities. They are often associated with injury sites (including surgical) which produce constant, often disabling pain and motor-sensory losses.
Treatments are often ineffective and include medications (often high dose opiates), physical therapy (PT(, and surgical interventions (sympathectomy, ablation) or insertion stimulators of the CNS.
Clinical Features include neurogenic inflammation, nociceptive sensitization, vasomotor dysfunction and maladaptive neuroplasticity. As these often seem related to specific injury sites (trauma, surgical, etc.) which are followed with severe pain sensations such as stabbing, burning, throbbing, and local muscular spasms or hemiparesis. In addition, there are many reports of visual change, dropping attacks (sudden falling), joint soreness, and other systemic symptoms associated with potentially any organ in the body.
Diagnosis typically recognizes 3 distinct "types" which do not appear to be sequential in nature. Type 1 characterization is severe, burning sensory change near an injury site, musculoskeletal and joint stiffness. Type 2 demonstrates very high pain levels, swelling, muscular atrophy, joint degeneration, depression, and other concomitant dysfunctions. Type 3 features irreversible changes to skin/bone, and extreme loss of function of muscle (atrophic primarily) and tendons. A significant percentage (13-70 ) are felt to be at risk if neurological injuries, hemiplegia, enhanced vasomotor issues due to enhanced sympathetic actions and neurotransmission issues.
This study includes microcannula harvesting of subdermal adipose tissues, incubation, digestion and isolation of AD-cSVF. This stromal cellular pellet (without actual extracellular matrix or stromal elements) is then suspended in 500 cc sterile Normal Saline (NS) and deployed via peripheral intravenous route. Evaluations of safety issues are measured at intervals (both severe and non-severe categories) and by repeated pulmonary function studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lipoaspiration Arm 1 | Experimental | Procedure: LipoaspirationAcquisition of Adipose-Derived tissue Stromal Vascular Fraction (AD-tSVF) via closed syringe lipoaspiration harvest of subdermal fat |
| AD-cSVF Arm 2 | Experimental | Procedure: ADcSVF isolationADcSVF Isolation of cellular stem/stromal cells from subdermal adipose-derived cellular stromal vascular fraction |
| Normal Saline IV Arm 3 | Experimental | Procedure: Normal Saline IVNormal Saline IV with AD-cSVF cells |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with confirmed diagnosis of RSD, CRPS, and severe Fibromyalgia
- Ability to provide Informed Consent (or as parent or legal guardian)
Key exclusion criteria (3 listed)
- Patients with severe comorbidities which, in opinion of PI or provider associates. would be unsafe or not advised to be able to comply with study or follow up requirements
- Patients with documented Opiate abuse
- Patient taking corticosteroid therapy, immune suppression, or chemotherapeutic regimen within 6 months of entry
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 |
|---|---|---|
| LipoaspirationClosed syringe harvesting subdermal fat | Procedure or surgery | Lipoaspiration Arm 1 |
| ADcSVF isolationIsolation of AD-cSVF from lipoaspirate via enzymatic digestion | Procedure or surgery | AD-cSVF Arm 2 |
| Normal Saline IVNormal Saline IV containing autologous AD-cSVF | Procedure or surgery | Normal Saline IV Arm 3 |
Primary outcome
Adverse and Severe Adverse Reaction Report
Time frame: 12 months
Evaluate any Adverse or Severe Adverse Reactions
3 secondary outcomes
Change from Baseline Pain Levels
Time frame: 1 month, 6 month, 1 year
Change in Quality of Life from Baseline
Time frame: 6 months, 12 months
Change from Baseline of Lifestyle
Time frame: 6 months, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 19590474Schwartzman RJ, Erwin KL, Alexander GM. The natural history of complex regional pain syndrome. Clin J Pain. 2009 May;25(4):273-80. doi: 10.1097/AJP.0b013e31818ecea5.
- Background: PubMed 21683929Marinus J, Moseley GL, Birklein F, Baron R, Maihofner C, Kingery WS, van Hilten JJ. Clinical features and pathophysiology of complex regional pain syndrome. Lancet Neurol. 2011 Jul;10(7):637-48. doi: 10.1016/S1474-4422(11)70106-5.
- Background: PubMed 8105263Veldman PH, Reynen HM, Arntz IE, Goris RJ. Signs and symptoms of reflex sympathetic dystrophy: prospective study of 829 patients. Lancet. 1993 Oct 23;342(8878):1012-6. doi: 10.1016/0140-6736(93)92877-v.
- Background: PubMed 15733635Maihofner C, Forster C, Birklein F, Neundorfer B, Handwerker HO. Brain processing during mechanical hyperalgesia in complex regional pain syndrome: a functional MRI study. Pain. 2005 Mar;114(1-2):93-103. doi: 10.1016/j.pain.2004.12.001. Epub 2005 Jan 26.
- Background: PubMed 15656873Watkins LR, Maier SF. Immune regulation of central nervous system functions: from sickness responses to pathological pain. J Intern Med. 2005 Feb;257(2):139-55. doi: 10.1111/j.1365-2796.2004.01443.x.
- Background: PubMed 15729516Birklein F. Complex regional pain syndrome. J Neurol. 2005 Feb;252(2):131-8. doi: 10.1007/s00415-005-0737-8.
- Background: PubMed 12091866Lee BH, Scharff L, Sethna NF, McCarthy CF, Scott-Sutherland J, Shea AM, Sullivan P, Meier P, Zurakowski D, Masek BJ, Berde CB. Physical therapy and cognitive-behavioral treatment for complex regional pain syndromes. J Pediatr. 2002 Jul;141(1):135-40. doi: 10.1067/mpd.2002.124380.
- Background: PubMed 21474244van de Meent H, Oerlemans M, Bruggeman A, Klomp F, van Dongen R, Oostendorp R, Frolke JP. Safety of "pain exposure" physical therapy in patients with complex regional pain syndrome type 1. Pain. 2011 Jun;152(6):1431-1438. doi: 10.1016/j.pain.2011.02.032. Epub 2011 Apr 6.
- Background: PubMed 19101181Swart CM, Stins JF, Beek PJ. Cortical changes in complex regional pain syndrome (CRPS). Eur J Pain. 2009 Oct;13(9):902-7. doi: 10.1016/j.ejpain.2008.11.010. Epub 2008 Dec 19.
- Background: PubMed 23546884Chopra P, Cooper MS. Treatment of Complex Regional Pain Syndrome (CRPS) using low dose naltrexone (LDN). J Neuroimmune Pharmacol. 2013 Jun;8(3):470-6. doi: 10.1007/s11481-013-9451-y. Epub 2013 Apr 2.
- Background: PubMed 22136149Azari P, Lindsay DR, Briones D, Clarke C, Buchheit T, Pyati S. Efficacy and safety of ketamine in patients with complex regional pain syndrome: a systematic review. CNS Drugs. 2012 Mar 1;26(3):215-28. doi: 10.2165/11595200-000000000-00000.
- Background: PubMed 2343234Opal SM, Wiest PM, Olds GR. Traveler's diarrhea: methods of prevention and treatment. R I Med J (1976). 1990 May;73(5):199-204.
- Individual participant dataSharing planned: No
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.
Glenn C Terry, MD principal investigator
Global Alliance for Regenerative Medicine (GARM)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lipoaspiration, ADcSVF isolation and Normal Saline IV in people with RSD (Reflex Sympathetic Dystrophy) and CRPS - Complex Regional Pain Syndrome Type I, run by Healeon Medical Inc at 2 sites in 2 countries.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 16 Feb 2021. 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, Honduras. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Adverse and Severe Adverse Reaction Report (time frame: 12 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 NCT02987855, which also lists 15 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 16 Feb 2021.