Venomous SnakebitesPhase 2/3TLE-RCTNCT04733781
Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine by Laypersons
A Phase 2/3 study testing Tumescent Lidocaine and Epinephrine in people with Venomous Snakebites and Local Anesthesia, run by Jeffrey Alan Klein, MD at 1 site in United States.
Trial summary
This research is intended to show that it is safe and not difficult for nearly anyone to inject at least 125ml of a dilute solution of tumescent lidocaine and epinephrine (TLE), where a TLE solution consists of lidocaine (1gm/L) and epinephrine (1mg/L) in normal saline. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venomous Snakebites, Local Anesthesia, Painless Injection
- What is being tested?
- Tumescent Lidocaine and Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 7 Jun 2021
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All volunteer subjects will be healthy, mature in behavior and temperament, without mental impairment and at least 16 years of age.
- A volunteer TLE research subject must be a non-medical-professional layperson and must have signed an IRB-approved informed consent form prior to participation.
- All subjects must weigh at least 40kg = 88lb
Who cannot join
- Anyone who has a significant fear of needles or fear of injections
- A history of lidocaine allergy.
- A significant history of epinephrine hypersensitivity.
- History of an adverse reaction to percutaneous injections, such as fainting and lightheadedness (vasovagal reactions, near syncope).
- Significant needle phobia or anxiety.
- Vasovagal reaction associated with any medical procedures or the sight of blood.
Show all 19Show fewer
- Uncontrolled or labile hypertension.
- Hyperthyroidism, thyroid medications.
- Recent phenylephrine (Actifed®) or pseudoephedrine use.
- Any significant cardiac arrhythmia including controlled atrial fibrillation tachycardia, mitral valve prolapse.
- Significant chronic renal impairment.
- Significant liver function abnormalities.
- History of having or having had a blood born infection with HIV, Hepatitis B, Hepatitis C.
- Evidence of active skin infection.
- Pregnant women are excluded.
- Subject has recently taken any drug(s) known to interfere with the metabolism of lidocaine such as erythromycin, clarithromycin, ketoconazole, fluconazole, sertraline (Zoloft), or ciprofloxacin.
- Subject has recently taken any drug known to interact adversely with epinephrine such as pseudoephedrine, ephedrine, or beta-blocker.
- History of radiation therapy or surgery involving the area near the proposed injection site.
- Pre-existing or concurrent infections (cutaneous, urinary, pneumonia are exclusionary).
Trial locations and contacts
1 site in 1 country.
United States1 site
HK Dermatology Care Center
San Juan Capistrano, California, 92675
Michele Horwich, RN, 949-248-1632, michele@kleinmd.com
Elena Novak, PA, (949) 248-1632, elena@kleinmd.com
About this study
Official title: Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine (TLE) by Laypersons: a Double-blind, Non-inferiority, Randomized Clinical Trial
This research is intended to show that it is safe and not difficult for nearly anyone to inject at least 125ml of a dilute solution of tumescent lidocaine and epinephrine (TLE), where a TLE solution consists of lidocaine (1gm/L) and epinephrine (1mg/L) in normal saline.
Read the detailed description
The primary aim of this research is to demonstrate that of subcutaneous injection of tumescent (dilute) lidocaine and epinephrine (TLE) is safe, well tolerated, and easily performed by nearly anyone who is at least 16 years old. The primary aim will be achieved by conducting an IRB-approved double-blind, non-inferiority, randomized clinical trial (RCT).
The indications for TLE when injected into subcutaneous tissue are
- Pre-hospital treatment of a snakebite envenomation (SBE)
- Dermatologic surgical procedures totally by local anesthesia
- Pure sensory regional anesthesia for significant cutaneous and musculoskeletal pain.
The present TLE-RCT has three research Arms, which are as follows:
Injection of 125ml by a physician and self-injection of 125ml by a volunteer (Arm I): A volunteer layperson (research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. Then the subject will self-inject a second 125ml of TLE into his/her right anterior thigh.
Injection of 125ml by a physician and 125ml by another volunteer (Arm II): A volunteer layperson (primary research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. The primary research subject will then receive a second 125ml of TLE injected into his/her right anterior thigh by a second adult volunteer who is at least 16 years old and not a medical professional.
Injection of 250ml by a physician into a volunteer (Arm III) : A volunteer layperson (research subject), at least 16 years of age, will receive 250ml of TLE injected subcutaneously into the one anterior thigh by a physician.
There will be two TLE formulations, F1 and F2.
- F1 contains epinephrine 1mg/L = 1:1,000,000, or 0.25mg/250ml.
- F2 contains epinephrine 2mg/L = 1:500,000, or 0.5mg/250ml. F1 and F2 will both contain lidocaine 1gm/L = 0.1gm/100ml = 0.1% The maximum dose of dilute tumescent epinephrine in F1 and F2 is 0.25mg and 0.5mg, respectively. An EpiPen® contains 0.3mg of epinephrine. The concentration of epinephrine in an EpiPen® is 1:1000, which is 1000 and 500 times greater than the concentration of epinephrine in F1 and F2, respectively.
Individual subjects will be randomly assigned to receive either F1 or F2. The maximum dosage of tumescent lidocaine is 5mg/kg, which is clearly a safe dosage given that the risk of mild lidocaine toxicity at 28mg/kg of 0.1% TLE is 1 per 5,000,000
- Conditions
- Venomous Snakebites, Local Anesthesia, Painless Injection, Regional Anesthesia, Dermatologic Surgery, Cutaneous Pain
- Being tested
- Tumescent Lidocaine and Epinephrine
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumescent Lidocaine and EpinephrineDrug
Also called Tumescent Local Anesthesia
Subcutaneous injection of a relatively large volume (125ml to 250ml) of a relatively dilute solution of lidocaine (1gm/L) and epinephrine (1mg/L or 2mg/L).
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous injection of 125ml by a physician and self-injection of 125ml by a volunteer (Arm I): | Active comparator | A volunteer layperson (research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. Then the subject will self-inject a second 125ml of TLE into his/her right anterior thigh. Receives: Drug: Tumescent Lidocaine and Epinephrine |
| Subcutaneous injection of 125ml by a physician and 125ml by another volunteer (Arm II): | Active comparator | A volunteer layperson (primary research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. The primary research subject will then receive a second 125ml of TLE injected into his/her right anterior thigh by a second adult volunteer who is at least 16 years old and not a medical professional. Receives: Drug: Tumescent Lidocaine and Epinephrine |
| Subcutaneous injection of 250ml by a physician into a volunteer (Arm III) | Active comparator | A volunteer layperson (research subject), at least 16 years old, will receive 250ml of TLE injected subcutaneously into the one anterior thigh by a physician. Receives: Drug: Tumescent Lidocaine and Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
the incidence of any clinically significant adverse event associated with TLE injection, such as pain at injection site, vasovagal event, tachycardia, infection
Measured: up to 24 hours
Secondary outcomes (5)
Numerical Pain Scale (NPS)
Numerical Pain Scale (NPS) score following each injection, where the range of he scale is 0 to 10, and where 0= "no pain" and 10="worst imaginable pain"
Measured: immediately after intervention
Pulse Rate
Measure difference between pulse rates before and after subcutaneous injection of 250ml of TLE.
Measured: up to 30 minutes after intervention
Blood Pressure Changes
Measure the differences between systolic and diastolic blood pressures before and after subcutaneous injection of 250ml of TLE.
Measured: up to 30 minutes after intervention
EKG rhythm changes
EKG rhythm strips will be recorded before and after 250ml of TLE and any significant changes will be documented. Prior to the initial subcutaneous injection of the TLE solution, the EKG rhythm will be noted and recorded. For example, if the "pre-TLE" rhythm is "Normal Sinus Rhythm (NSR)" this observation will be recorded. After the subcutaneous TLE injection, a second EKG rhythm will be recorded. The analysis of the these two EKG rhythm strips will provide a dichotomous outcome variable: "no clinically significant EKG change" or "potentially significant EKG change." If there is a significant EKG rhythm strip change, then any relevant clinical details or observations will be recorded.
Measured: up to 30 minutes after intervention
Human-Factors Associated with subcutaneous injection of a largfe volume of a TLE solution.
Human-factor, or user interface difficulties encountered during the TLE injection process will be observed and a narrative of the observations will be recorded. The TLE-RCT is intended to demonstrate that any layperson can give a 125ml subcutaneous injection of a TLE in a manner that is safe and effective and essentially non-inferior to a similar injection administered by a physician. We will observe and record an apparent difficulties experience by the layperson when giving the injection. We will ask questions of the layperson to determine if the "instructions for use" are sufficient, and if not, we will record their suggestions for improvement.
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start22 Feb 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion7 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Venomous SnakebitesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- double-blind, non-inferiority, randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeffrey Alan Klein, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Jeffrey Alan Klein, MD, HK Surgical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733781
- Sponsor's protocol ID
- TLE-RCT
- Acronym
- TLE-RCT
- Status last verified
- Feb 2021
- First submitted
- 24 Jan 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researcher, who wish to replicate our RCT-TLE trial will be provided with de-identified data upon request.
Publications
Makdisi JR, Kim DP, Klein PA, Klein JA. Tumescent contravenom: murine model for prehospital treatment of Naja naja neurotoxic snake envenomation. Int J Dermatol. 2018 May;57(5):605-610. doi: 10.1111/ijd.13877. Epub 2018 Feb 20.
PubMed 29460967Klein JA, Jeske DR. Estimated Maximal Safe Dosages of Tumescent Lidocaine. Anesth Analg. 2016 May;122(5):1350-9. doi: 10.1213/ANE.0000000000001119.
PubMed 26895001Klein JA, Langman LJ. Prevention of Surgical Site Infections and Biofilms: Pharmacokinetics of Subcutaneous Cefazolin and Metronidazole in a Tumescent Lidocaine Solution. Plast Reconstr Surg Glob Open. 2017 May 30;5(5):e1351. doi: 10.1097/GOX.0000000000001351. eCollection 2017 May.
PubMed 28607871Klein JA. Tumescent technique for local anesthesia improves safety in large-volume liposuction. Plast Reconstr Surg. 1993 Nov;92(6):1085-98; discussion 1099-100.
PubMed 8234507Klein JA. The tumescent technique for liposuction surgery. J Am Acad Cosmetic Surg, 1987; 4:263-267.
US Patent 10,786,483 B2. JA Klein, PA Klein, BA Klein. Tumescent Contravenom Drug Delivery (Sep 29, 2020).
US Patent 10,493,024 B2. Klein. Tumescent infiltration drug delivery of high subcutaneous drug concentrations with prolonged local and systemic effects and minimal local or systemic toxicity (Dec 3, 2019).
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Injection of Large Volumes of Tumescent Lidocaine and Epinephrine (TLE) by Laypersons: a Double-blind, Non-inferiority, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04733781
- Acronym / sponsor ID
- TLE-RCT / TLE-RCT
- Conditions
- Venomous Snakebites, Local Anesthesia, Painless Injection, Regional Anesthesia, Dermatologic Surgery, Cutaneous Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Jeffrey Alan Klein, MDIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 7 Jun 2021 (estimated)
- First posted
- 2 Feb 2021 (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 research is intended to show that it is safe and not difficult for nearly anyone to inject at least 125ml of a dilute solution of tumescent lidocaine and epinephrine (TLE), where a TLE solution consists of lidocaine (1gm/L) and epinephrine (1mg/L) in normal saline.
Detailed description
The primary aim of this research is to demonstrate that of subcutaneous injection of tumescent (dilute) lidocaine and epinephrine (TLE) is safe, well tolerated, and easily performed by nearly anyone who is at least 16 years old. The primary aim will be achieved by conducting an IRB-approved double-blind, non-inferiority, randomized clinical trial (RCT).
The indications for TLE when injected into subcutaneous tissue are
- Pre-hospital treatment of a snakebite envenomation (SBE)
- Dermatologic surgical procedures totally by local anesthesia
- Pure sensory regional anesthesia for significant cutaneous and musculoskeletal pain.
The present TLE-RCT has three research Arms, which are as follows:
Injection of 125ml by a physician and self-injection of 125ml by a volunteer (Arm I): A volunteer layperson (research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. Then the subject will self-inject a second 125ml of TLE into his/her right anterior thigh.
Injection of 125ml by a physician and 125ml by another volunteer (Arm II): A volunteer layperson (primary research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. The primary research subject will then receive a second 125ml of TLE injected into his/her right anterior thigh by a second adult volunteer who is at least 16 years old and not a medical professional.
Injection of 250ml by a physician into a volunteer (Arm III) : A volunteer layperson (research subject), at least 16 years of age, will receive 250ml of TLE injected subcutaneously into the one anterior thigh by a physician.
There will be two TLE formulations, F1 and F2.
- F1 contains epinephrine 1mg/L = 1:1,000,000, or 0.25mg/250ml.
- F2 contains epinephrine 2mg/L = 1:500,000, or 0.5mg/250ml. F1 and F2 will both contain lidocaine 1gm/L = 0.1gm/100ml = 0.1% The maximum dose of dilute tumescent epinephrine in F1 and F2 is 0.25mg and 0.5mg, respectively. An EpiPen® contains 0.3mg of epinephrine. The concentration of epinephrine in an EpiPen® is 1:1000, which is 1000 and 500 times greater than the concentration of epinephrine in F1 and F2, respectively.
Individual subjects will be randomly assigned to receive either F1 or F2. The maximum dosage of tumescent lidocaine is 5mg/kg, which is clearly a safe dosage given that the risk of mild lidocaine toxicity at 28mg/kg of 0.1% TLE is 1 per 5,000,000
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- double-blind, non-inferiority, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous injection of 125ml by a physician and self-injection of 125ml by a volunteer (Arm I): | Active comparator | Drug: Tumescent Lidocaine and EpinephrineA volunteer layperson (research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. Then the subject will self-inject a second 125ml of TLE into his/her right anterior thigh. |
| Subcutaneous injection of 125ml by a physician and 125ml by another volunteer (Arm II): | Active comparator | Drug: Tumescent Lidocaine and EpinephrineA volunteer layperson (primary research subject), at least 16 years of age, will first receive 125ml of TLE injected subcutaneously into the left anterior thigh by a physician. The primary research subject will then receive a second 125ml of TLE injected into his/her right anterior thigh by a second adult volunteer who is at least 16 years old and not a medical professional. |
| Subcutaneous injection of 250ml by a physician into a volunteer (Arm III) | Active comparator | Drug: Tumescent Lidocaine and EpinephrineA volunteer layperson (research subject), at least 16 years old, will receive 250ml of TLE injected subcutaneously into the one anterior thigh by a physician. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All volunteer subjects will be healthy, mature in behavior and temperament, without mental impairment and at least 16 years of age.
- A volunteer TLE research subject must be a non-medical-professional layperson and must have signed an IRB-approved informed consent form prior to participation.
- All subjects must weigh at least 40kg = 88lb
Key exclusion criteria (19 listed)
- Anyone who has a significant fear of needles or fear of injections
- A history of lidocaine allergy.
- A significant history of epinephrine hypersensitivity.
- History of an adverse reaction to percutaneous injections, such as fainting and lightheadedness (vasovagal reactions, near syncope).
- Significant needle phobia or anxiety.
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 |
|---|---|---|
| Tumescent Lidocaine and EpinephrineAlso: Tumescent Local AnesthesiaSubcutaneous injection of a relatively large volume (125ml to 250ml) of a relatively dilute solution of lidocaine (1gm/L) and epinephrine (1mg/L or 2mg/L). | Drug | Subcutaneous injection of 125ml by a physician and 125ml by another volunteer (Arm II):, Subcutaneous injection of 125ml by a physician and self-injection of 125ml by a volunteer (Arm I):, Subcutaneous injection of 250ml by a physician into a volunteer (Arm III) |
Primary outcome
Adverse Events
Time frame: up to 24 hours
the incidence of any clinically significant adverse event associated with TLE injection, such as pain at injection site, vasovagal event, tachycardia, infection
5 secondary outcomes
Numerical Pain Scale (NPS)
Time frame: immediately after intervention
Pulse Rate
Time frame: up to 30 minutes after intervention
Blood Pressure Changes
Time frame: up to 30 minutes after intervention
EKG rhythm changes
Time frame: up to 30 minutes after intervention
Human-Factors Associated with subcutaneous injection of a largfe volume of a TLE solution.
Time frame: during the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Background: PubMed 29460967Makdisi JR, Kim DP, Klein PA, Klein JA. Tumescent contravenom: murine model for prehospital treatment of Naja naja neurotoxic snake envenomation. Int J Dermatol. 2018 May;57(5):605-610. doi: 10.1111/ijd.13877. Epub 2018 Feb 20.
- Background: PubMed 26895001Klein JA, Jeske DR. Estimated Maximal Safe Dosages of Tumescent Lidocaine. Anesth Analg. 2016 May;122(5):1350-9. doi: 10.1213/ANE.0000000000001119.
- Background: PubMed 28607871Klein JA, Langman LJ. Prevention of Surgical Site Infections and Biofilms: Pharmacokinetics of Subcutaneous Cefazolin and Metronidazole in a Tumescent Lidocaine Solution. Plast Reconstr Surg Glob Open. 2017 May 30;5(5):e1351. doi: 10.1097/GOX.0000000000001351. eCollection 2017 May.
- Background: PubMed 8234507Klein JA. Tumescent technique for local anesthesia improves safety in large-volume liposuction. Plast Reconstr Surg. 1993 Nov;92(6):1085-98; discussion 1099-100.
- BackgroundKlein JA. The tumescent technique for liposuction surgery. J Am Acad Cosmetic Surg, 1987; 4:263-267.
- BackgroundUS Patent 10,786,483 B2. JA Klein, PA Klein, BA Klein. Tumescent Contravenom Drug Delivery (Sep 29, 2020).
- BackgroundUS Patent 10,493,024 B2. Klein. Tumescent infiltration drug delivery of high subcutaneous drug concentrations with prolonged local and systemic effects and minimal local or systemic toxicity (Dec 3, 2019).
- Individual participant dataSharing planned: Yes. Other researcher, who wish to replicate our RCT-TLE trial will be provided with de-identified data upon request.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tumescent Lidocaine and Epinephrine in people with Venomous Snakebites and Local Anesthesia, run by Jeffrey Alan Klein, MD 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 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 8 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jeffrey A Klein, MD ((949) 283-1070, jeff@kleinmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: up to 24 hours). 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 NCT04733781, which also lists 7 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 8 Feb 2021.