Osteoarthritis of KneeNCT02623660
Microcurrent Stimulation Reduces Post-Operative Swelling and Healing Time Following Knee Replacement Surgery
A study testing ODIN1 and Diagnostic Device Testing in people with Osteoarthritis of Knee and Edema, run by Bioelectric Research Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to determine if patients undergoing a total knee arthroplasty (TKA) experience a clinically significant reduction in healing time when treated post operatively with a specific form of micro and nano-ampere current. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of Knee, Edema, Wounds and Injuries
- What is being tested?
- ODIN1 and Diagnostic Device Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Oct 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be scheduled for a primary total knee replacement surgery
- Age: 18 - 80 years old
- Males/Females all ethnicities
- Must have a minimum serum albumin of 4 and a minimum Hgb of 11
- Ability to mark appropriately the visual analog scales, keep a log of symptoms, medication use, and ODIN1® use
- Ability to understand all instructions and the informed consent document before signing it
Who cannot join
- Subject younger than 18 years of age
- Any patient with an electrically implanted device such as a pacemaker, neural stimulator, etc.
- Subject has any known neoplasms
- A demonstrated lack of compliance as determined by the Principal Investigator, nurse, or wound care specialist
- Current participation in another clinical study of an investigational device or drug.
- Any other condition or finding, which in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the protocol
Show all 19Show fewer
- Subject unwilling or unable to provide informed consent
- Subjects receiving any medication or having any condition that significantly interferes with the healing process such as a patient taking systemic steroids or immune suppressants or patient has diabetes mellitus with an HbA1c of greater than 7.5, etc.
- Any female who has experienced menstruation and is less than 5 years postmenopausal shall have a urine pregnancy test before the initial treatment. An additional test will be performed at 3 weeks from the initial treatment date. Any subject with a positive pregnancy test shall be excluded
- Subjects with significant peripheral extremity lymph edema
- Subjects with Stage III or IV peripheral vascular disease, as defined by the Fontaine stages
- Subjects with venous insufficiencies of Class III or greater, as defined by the Comprehensive Classification System for Chronic Venous Disorders (CEAP)
- Subjects with muscle skeletal disorders that are not related to the knee
- Subjects with uncontrolled Blood Pressure
- Subjects with neurological disease affecting locomotion
- Subjects with BMI > 35
- Subjects that are active smokers
- Subjects that live on the second floor or higher without elevator access
- Subjects must not have had a prior TKA. This study is for Primary TKA patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nevada Orthopedic and Spine Center
Las Vegas, Nevada, 89128
Centennial Hills Hospital
Las Vegas, Nevada, 89149
About this study
Official title: Accelerated Reduction of Post-operative Edema and Early Return to Function Following Total Knee Arthroplasty (TKA)
The purpose of this study is to determine if patients undergoing a total knee arthroplasty (TKA) experience a clinically significant reduction in healing time when treated post operatively with a specific form of micro and nano-ampere current. The results of this trial will provide a basis for generalizing its outcomes to apply to other joint replacements and revisions by reducing edema and inflammation and therefore will result in a shorter time to heal.
The study will compare electrically treated and non electrically treated patients by using digitally based measurements to determine objective reductions of lower extremity edema including intra and inter cellular shifts in fluid distribution, increased range of motion (ROM) and muscle strength, and improved functional tests of ambulation.
Read the detailed description
This study is intended to assess the efficiency and efficacy of the ODIN1® microcurrent generating device to reduce post-operative edema, shorten the time to heal and regain maximum function in total knee replacement patients. Changes in swelling will be documented by utilizing a 3D scanning device (Perometer) and a Bio-Impedance Spectroscopy (BIS) device (Impedimed SFB7). These instruments quantitate limb volume and inter and intra-cellular fluid respectively with a high degree of accuracy. Measurements will be made from the first post-operative day until the completion of rehabilitation therapy several months later.
Edema volume and fluid distribution data collected from both control and experimental groups will be compared to determine the statistical significance of the difference between these groups. An additional analysis will be performed on data collected from the non-operated lower limb of each patient.
The second primary objective is to determine the time to complete post-op rehabilitation. Completion will be determined by the ability of the patient to experience an optimal outcome by utilizing performance based measurements of knee function including quadriceps strength and range of motion. The time from surgery to optimal post-op rehabilitation will be recorded.
The determinations of statistical significance between the electrically treated and non-electrically treated groups will be made by analysts on a blind basis. They will not know whether a sample data set is from an experimental or control patient. The codes that document which group the set belongs to will be opened after all analysis is completed by an independent analyst.
- Conditions
- Osteoarthritis of Knee, Edema, Wounds and Injuries
- Being tested
- ODIN1, Standard Care, Diagnostic Device Testing
- Keywords
- Inflammation, Edema, Arthroplasty, Rehabilitation, Replacement, Knee, Total Knee Replacement, Pain, Postoperative, Exercise Therapy, Therapeutics, Early Ambulation, Myofunctional Therapy, Electric Stimulation Therapy, Orthopedic Procedures, Wound Healing, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Edema, Wounds and Injuries, Inflammation, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODIN1Device
Shortly after surgery, electrodes will be applied to the lower extremity in such a way that the current will flow from the ankle through the knee replacement and pass through the thigh. The frequency of the treatments will vary over the period of time from post-op recovery to end of rehab.
All treatments are applying current that consists of different combinations of intensities within the micro to nano ampere ranges.
Standard CareOther
Anti-thrombotic medication. Elevation and ice. Pain medications as needed. Dressings changes. Topical antibiotics. Progressive physical therapy.
Diagnostic Device TestingDevice
Diagnostic interventions include: the Perometer which scans the lower extremity and determines its volume to a high degree of accuracy; the Impedimed Bioimpedance Spectroscopy (BIS) device that measures intra and intercellular fluid movement; the Microfet muscle force testing device that provides a digital output of the number of pounds exerted by the quadriceps upon extension; the Acumar digital digital Inclinometer that accurately measures the ROM of the knee; and the K.I.S.S. wound measuring system to measure rate of incision healing.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | This group will receive treatment from the ODIN1 device in conjunction with standard care and diagnostic device testing. Receives: Device: ODIN1; Other: Standard Care; Device: Diagnostic Device Testing |
| Control | Active comparator | This group will receive the standard care and the diagnostic device testing. Receives: Other: Standard Care; Device: Diagnostic Device Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Reduction of post-operative edema
Determine the rate of reduction in edema by measuring the volume changes in the operated lower extremity over time
Measured: 120 days
Decrease in time to heal
Determine the rate of healing by measuring the time elapsed from surgery to reach optimal function by measuring muscle strength, range of knee motion, standardized rehabilitation testing designed to quantitatively measure ambulation. When these measurements show no signs of improvement for a period of 30 days or greater, then the time elapsed after surgery until the beginning of this 30 day or greater period will be recorded and used as a measure of time to heal.
Measured: 120 Days
Secondary outcomes (4)
Reduction of pain
Record the degree of pain experienced by measuring the pain level on the universal pain scale of 1-10 over time elapsed since surgery.
Measured: 90 days
Reduction of bacterial infections
Compare the incidence of TKA related infections in all participants. The measurement will be the number of recorded infections, related to the surgery, that has occurred within the first 60 days of that surgery in all participants. That number will be compared between the experimental and the control groups.
Measured: 60 Days
Increased healing of the surgical incision
Photograph and rate incision healing from 1st post-op day through day 60 comparing all participants.
Measured: From the 1st post-op day until 60 Days post-op
Reduction of Pain Medication Usage
Record the consumption of all pain medications consumed to mitigate post-operative pain. A total dosage will be calculated in terms of morphine equivalent strengths and compared between the groups.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (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 Osteoarthritis of KneeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioelectric Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Hillock, M.D., Principal investigator, Centennial Hills Hospital & University of Nevada School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623660
- Sponsor's protocol ID
- BRC-001
- Status last verified
- Jan 2016
- First submitted
- 1 Dec 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shi R, Borgens RB. Three-dimensional gradients of voltage during development of the nervous system as invisible coordinates for the establishment of embryonic pattern. Dev Dyn. 1995 Feb;202(2):101-14. doi: 10.1002/aja.1002020202.
PubMed 7734729Hotary KB, Robinson KR. Endogenous electrical currents and voltage gradients in Xenopus embryos and the consequences of their disruption. Dev Biol. 1994 Dec;166(2):789-800. doi: 10.1006/dbio.1994.1357.
PubMed 7813796Soong HK, Parkinson WC, Bafna S, Sulik GL, Huang SC. Movements of cultured corneal epithelial cells and stromal fibroblasts in electric fields. Invest Ophthalmol Vis Sci. 1990 Nov;31(11):2278-82.
PubMed 2242993Zhao M, Dick A, Forrester JV, McCaig CD. Electric field-directed cell motility involves up-regulated expression and asymmetric redistribution of the epidermal growth factor receptors and is enhanced by fibronectin and laminin. Mol Biol Cell. 1999 Apr;10(4):1259-76. doi: 10.1091/mbc.10.4.1259.
PubMed 10198071Lin F, Baldessari F, Gyenge CC, Sato T, Chambers RD, Santiago JG, Butcher EC. Lymphocyte electrotaxis in vitro and in vivo. J Immunol. 2008 Aug 15;181(4):2465-71. doi: 10.4049/jimmunol.181.4.2465.
PubMed 18684937McCaig CD, Rajnicek AM, Song B, Zhao M. Controlling cell behavior electrically: current views and future potential. Physiol Rev. 2005 Jul;85(3):943-78. doi: 10.1152/physrev.00020.2004.
PubMed 15987799Sato MJ, Kuwayama H, van Egmond WN, Takayama AL, Takagi H, van Haastert PJ, Yanagida T, Ueda M. Switching direction in electric-signal-induced cell migration by cyclic guanosine monophosphate and phosphatidylinositol signaling. Proc Natl Acad Sci U S A. 2009 Apr 21;106(16):6667-72. doi: 10.1073/pnas.0809974106. Epub 2009 Apr 3.
PubMed 19346484Li L, Gu W, Du J, Reid B, Deng X, Liu Z, Zong Z, Wang H, Yao B, Yang C, Yan J, Zeng L, Chalmers L, Zhao M, Jiang J. Electric fields guide migration of epidermal stem cells and promote skin wound healing. Wound Repair Regen. 2012 Nov-Dec;20(6):840-51. doi: 10.1111/j.1524-475X.2012.00829.x. Epub 2012 Oct 19.
PubMed 23082865Man IO, Markland KL, Morrissey MC. The validity and reliability of the Perometer in evaluating human knee volume. Clin Physiol Funct Imaging. 2004 Nov;24(6):352-8. doi: 10.1111/j.1475-097X.2004.00577.x.
PubMed 15522044Pichonnaz C, Bassin JP, Currat D, Martin E, Jolles BM. Bioimpedance for oedema evaluation after total knee arthroplasty. Physiother Res Int. 2013 Sep;18(3):140-7. doi: 10.1002/pri.1540. Epub 2012 Nov 27.
PubMed 23188719
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Reduction of Post-operative Edema and Early Return to Function Following Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT02623660
- Acronym / sponsor ID
- BRC-001
- Conditions
- Osteoarthritis of Knee, Edema, Wounds and Injuries
- Keywords
- Inflammation, Edema, Arthroplasty, Rehabilitation, Replacement, Knee, Total Knee Replacement, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bioelectric Research CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 8 Dec 2015 (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.
The purpose of this study is to determine if patients undergoing a total knee arthroplasty (TKA) experience a clinically significant reduction in healing time when treated post operatively with a specific form of micro and nano-ampere current. The results of this trial will provide a basis for generalizing its outcomes to apply to other joint replacements and revisions by reducing edema and inflammation and therefore will result in a shorter time to heal.
The study will compare electrically treated and non electrically treated patients by using digitally based measurements to determine objective reductions of lower extremity edema including intra and inter cellular shifts in fluid distribution, increased range of motion (ROM) and muscle strength, and improved functional tests of ambulation.
Detailed description
This study is intended to assess the efficiency and efficacy of the ODIN1® microcurrent generating device to reduce post-operative edema, shorten the time to heal and regain maximum function in total knee replacement patients. Changes in swelling will be documented by utilizing a 3D scanning device (Perometer) and a Bio-Impedance Spectroscopy (BIS) device (Impedimed SFB7). These instruments quantitate limb volume and inter and intra-cellular fluid respectively with a high degree of accuracy. Measurements will be made from the first post-operative day until the completion of rehabilitation therapy several months later.
Edema volume and fluid distribution data collected from both control and experimental groups will be compared to determine the statistical significance of the difference between these groups. An additional analysis will be performed on data collected from the non-operated lower limb of each patient.
The second primary objective is to determine the time to complete post-op rehabilitation. Completion will be determined by the ability of the patient to experience an optimal outcome by utilizing performance based measurements of knee function including quadriceps strength and range of motion. The time from surgery to optimal post-op rehabilitation will be recorded.
The determinations of statistical significance between the electrically treated and non-electrically treated groups will be made by analysts on a blind basis. They will not know whether a sample data set is from an experimental or control patient. The codes that document which group the set belongs to will be opened after all analysis is completed by an independent analyst.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: ODIN1, Other: Standard Care, Device: Diagnostic Device TestingThis group will receive treatment from the ODIN1 device in conjunction with standard care and diagnostic device testing. |
| Control | Active comparator | Other: Standard Care, Device: Diagnostic Device TestingThis group will receive the standard care and the diagnostic device testing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be scheduled for a primary total knee replacement surgery
- Age: 18 - 80 years old
- Males/Females all ethnicities
- Must have a minimum serum albumin of 4 and a minimum Hgb of 11
- Ability to mark appropriately the visual analog scales, keep a log of symptoms, medication use, and ODIN1® use
Key exclusion criteria (19 listed)
- Subject younger than 18 years of age
- Any patient with an electrically implanted device such as a pacemaker, neural stimulator, etc.
- Subject has any known neoplasms
- A demonstrated lack of compliance as determined by the Principal Investigator, nurse, or wound care specialist
- Current participation in another clinical study of an investigational device or drug.
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 |
|---|---|---|
| ODIN1Shortly after surgery, electrodes will be applied to the lower extremity in such a way that the current will flow from the ankle through the knee replacement and pass through the thigh. The frequency of the treatments will vary over the period of time from post-op recovery to end of rehab. All treatments are applying current that consists of different combinations of intensities within the micro to nano ampere ranges. | Device | Experimental |
| Standard CareAnti-thrombotic medication. Elevation and ice. Pain medications as needed. Dressings changes. Topical antibiotics. Progressive physical therapy. | Other | Control, Experimental |
| Diagnostic Device TestingDiagnostic interventions include: the Perometer which scans the lower extremity and determines its volume to a high degree of accuracy; the Impedimed Bioimpedance Spectroscopy (BIS) device that measures intra and intercellular fluid movement; the Microfet muscle force testing device that provides a digital output of the number of pounds exerted by the quadriceps upon extension; the Acumar digital digital Inclinometer that accurately measures the ROM of the knee; and the K.I.S.S. wound measuring system to measure rate of incision healing. | Device | Control, Experimental |
Primary outcome
Rate of Reduction of post-operative edema
Time frame: 120 days
Determine the rate of reduction in edema by measuring the volume changes in the operated lower extremity over time
Decrease in time to heal
Time frame: 120 Days
Determine the rate of healing by measuring the time elapsed from surgery to reach optimal function by measuring muscle strength, range of knee motion, standardized rehabilitation testing designed to quantitatively measure ambulation. When these measurements show no signs of improvement for a period of 30 days or greater, then the time elapsed after surgery until the beginning of this 30 day or greater period will be recorded and used as a measure of time to heal.
4 secondary outcomes
Reduction of pain
Time frame: 90 days
Reduction of bacterial infections
Time frame: 60 Days
Increased healing of the surgical incision
Time frame: From the 1st post-op day until 60 Days post-op
Reduction of Pain Medication Usage
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Background: PubMed 7734729Shi R, Borgens RB. Three-dimensional gradients of voltage during development of the nervous system as invisible coordinates for the establishment of embryonic pattern. Dev Dyn. 1995 Feb;202(2):101-14. doi: 10.1002/aja.1002020202.
- Background: PubMed 7813796Hotary KB, Robinson KR. Endogenous electrical currents and voltage gradients in Xenopus embryos and the consequences of their disruption. Dev Biol. 1994 Dec;166(2):789-800. doi: 10.1006/dbio.1994.1357.
- Background: PubMed 2242993Soong HK, Parkinson WC, Bafna S, Sulik GL, Huang SC. Movements of cultured corneal epithelial cells and stromal fibroblasts in electric fields. Invest Ophthalmol Vis Sci. 1990 Nov;31(11):2278-82.
- Background: PubMed 10198071Zhao M, Dick A, Forrester JV, McCaig CD. Electric field-directed cell motility involves up-regulated expression and asymmetric redistribution of the epidermal growth factor receptors and is enhanced by fibronectin and laminin. Mol Biol Cell. 1999 Apr;10(4):1259-76. doi: 10.1091/mbc.10.4.1259.
- Background: PubMed 18684937Lin F, Baldessari F, Gyenge CC, Sato T, Chambers RD, Santiago JG, Butcher EC. Lymphocyte electrotaxis in vitro and in vivo. J Immunol. 2008 Aug 15;181(4):2465-71. doi: 10.4049/jimmunol.181.4.2465.
- Background: PubMed 15987799McCaig CD, Rajnicek AM, Song B, Zhao M. Controlling cell behavior electrically: current views and future potential. Physiol Rev. 2005 Jul;85(3):943-78. doi: 10.1152/physrev.00020.2004.
- Background: PubMed 19346484Sato MJ, Kuwayama H, van Egmond WN, Takayama AL, Takagi H, van Haastert PJ, Yanagida T, Ueda M. Switching direction in electric-signal-induced cell migration by cyclic guanosine monophosphate and phosphatidylinositol signaling. Proc Natl Acad Sci U S A. 2009 Apr 21;106(16):6667-72. doi: 10.1073/pnas.0809974106. Epub 2009 Apr 3.
- Background: PubMed 23082865Li L, Gu W, Du J, Reid B, Deng X, Liu Z, Zong Z, Wang H, Yao B, Yang C, Yan J, Zeng L, Chalmers L, Zhao M, Jiang J. Electric fields guide migration of epidermal stem cells and promote skin wound healing. Wound Repair Regen. 2012 Nov-Dec;20(6):840-51. doi: 10.1111/j.1524-475X.2012.00829.x. Epub 2012 Oct 19.
- Background: PubMed 15522044Man IO, Markland KL, Morrissey MC. The validity and reliability of the Perometer in evaluating human knee volume. Clin Physiol Funct Imaging. 2004 Nov;24(6):352-8. doi: 10.1111/j.1475-097X.2004.00577.x.
- Background: PubMed 23188719Pichonnaz C, Bassin JP, Currat D, Martin E, Jolles BM. Bioimpedance for oedema evaluation after total knee arthroplasty. Physiother Res Int. 2013 Sep;18(3):140-7. doi: 10.1002/pri.1540. Epub 2012 Nov 27.
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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.
Ron Hillock, M.D. principal investigator
Centennial Hills Hospital & University of Nevada School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ODIN1 and Diagnostic Device Testing in people with Osteoarthritis of Knee and Edema, run by Bioelectric Research Corporation 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 6 inclusion and 19 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 12 Jan 2016. 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?
Rate of Reduction of post-operative edema (time frame: 120 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02623660, 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 12 Jan 2016; AzTrials last refreshed its copy on 1 Nov 2026.