PainNCT03467230
Performance Assessment of the PMD-200 Under General Anesthesia
An observational study of Pain and Opioid Use, run by University of Vermont at 1 site in United States.
Trial summary
A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a combination of nociception-related physiologic variables, which estimates the nociceptive/antinociceptive state. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Opioid Use, Intraoperative Complications
- What is being tested?
- NoL Index
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 12 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients ASA I-III scheduled for general anesthesia for laparoscopic GI or GU procedures.
Who may be able to join
- Age > 18 years old.
- Requiring laparoscopic gastrointestinal or laparoscopic hysterectomy under general anesthesia (without regional anesthesia)
- Patient provides informed consent
Who cannot join
- History of severe cardiac arrhythmias within the last 12 months
- Chronic pain conditions or analgesic usage (>1 month of large doses of opioids: more than 30mg oral equivalent of morphine)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Performance Assessment of the PMD-200 in Subjects Requiring Surgery Under General Anesthesia
A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a combination of nociception-related physiologic variables, which estimates the nociceptive/antinociceptive state.
The purpose of this project is to conduct an observational study of the PMD-200 noninvasive monitor (Medasense Biometrics Ltd., Ramat Gan, Israel), As this is an observational study, this monitor will not be used for clinical decision making, and the point of the study is to assess what happens with the NoL index during routine care. After thorough discussion with patients and written informed consent is provided in the pre-operative unit, patients will be transferred to the operating room. Patients will be connected to a vital sign monitor and any other medical equipment needed for the surgical procedure, as required by the standard of practice. The PMD-200 finger probe will be connected to the left hand middle finger (or right). The PMD-200 will be activated after the induction of general anesthesia. A calibration period of 1-2 minutes will be performed. At the conclusion of the surgical procedure, the PMD200 will be disconnected from the patient.
All the phases of anesthetic care are performed at the discretion of the anesthesiologist, but the time of administration of analgesics, muscle relaxants and other medications during anesthetic care will be recorded. The investigators will also record the time point of intubation (placement of breathing tube), extubation (removal of breathing tube), skin incision and any other significant surgical stimulation or noxious stimulation during the procedure. The investigators will be comparing NOL values prior to and following noxious stimuli, administration of analgesic agents and during non-noxious periods.
Read the detailed description
The primary efficacy objective of this study is to demonstrate that the NOL Index of the PMD-200 monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) is correlated with the responses to noxious stimuli and analgesic administration during the surgical procedure (prior and following a stimuli or titration), and the secondary efficacy objective of the study is to determine whether the NOL values can be correlated to other nociception predictors (e.g., increase in heart rate or blood pressure) following a noxious stimuli. The primary safety objective of this study is to assess the rate of any adverse reaction related to the study device. This device will not be used to make any clinical decision.
General anesthesia is the combination of various components including lack of movement, hypnosis, amnesia, control of autonomic responses, and attenuation of the response to noxious stimulation. Some anesthetic components, such as muscle relaxation and absence of movement are easy to assess with a twitch monitor. Similarly, hypnotic state can be estimated using processed electroencephalographic signals, but the anesthetic component that remains the most challenging to assess is the nociceptive/antinociceptive state. Typically, intraoperative nociception is estimated from autonomic responses (such as change in blood pressure and heart rate) and clinical signs such as tearing and sweating, but these variables can be very unreliable in predicting pain such as in patients who take beta blockers for treatment of high blood pressure whose heart rate may not increase in response to pain, patients with significant bleeding during surgery whose blood pressure may not increase in response to pain, etc. Effective antinociception is an important component of balanced anesthesia and appears to enhance postoperative outcomes. The most obvious potential consequence of insufficient intraoperative antinociceptive treatment is excessive postoperative pain, but inadequate treatment may also promote inflammatory, hormonal, and immunologic imbalances.
A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a nonlinear combination of nociception-related physiologic variables, specifically heart rate (HR), heart rate variability at the 0.15- to 0.4-Hz band power, photoplethysmograph wave amplitude (PPGA), skin conductance level, number of skin conductance fluctuations, and their time derivatives. The NoL index estimates the nociceptive/antinociceptive state from these components measures using random forest regression. Previous experimental work on a small number of patients showed that the NoL index is superior to each individual component and to a linear combination of the components. However, it remains unknown whether the NoL index accurately quantifies patients' intraoperative responses to noxious stimuli of varying intensities. The investigators therefore wish to evaluate the ability of the NoL index to discriminate noxious from nonnoxious stimuli, respond to analgesic administration, and progressively increase in response to increasing intensity of noxious stimulation.
In this observational study, The investigators attempt to learn the proper use of the PMD-200 and assess safety and efficacy of this device as mentioned above; however, no clinical decision will be based on the NoL index obtained.
- Conditions
- Pain, Opioid Use, Intraoperative Complications
- Being tested
- NoL Index
- Medical subject headings
- Pain, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoL IndexDevice
Use of the PMD-200 in an observational study
| Study group | Role | What they receive |
|---|---|---|
| NoL Index | All patients will be monitored by PMD-200 device Receives: Device: NoL Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy objective: Correlation of NoL Index with noxious stimulation/analgesic use
To demonstrate that the NOL Index of the PMD-200 monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) is correlated with the responses to noxious stimuli and analgesic administration during the surgical procedure (prior and following a stimuli or titration). Specifically, the investigators will assess the % change from baseline-steady state NoL Index value with the NoL Index value during surgical stimulation (increased noxious stimulation) as well as the NoL Index value after administration of analgesics (decreased noxious stimulation).
Measured: Intraoperatively
Secondary outcomes (3)
the secondary efficacy objective: Correlation of NoL Index with changes in heart rate
To determine whether the NOL values can be correlated to other nociception predictors (increase in heart rate) following a noxious stimuli.
Measured: Intraoperatively
the secondary efficacy objective: Correlation of NoL Index with blood pressure
To determine whether the NOL values can be correlated to other nociception predictors (increase in blood pressure) following a noxious stimuli.
Measured: Intraoperatively
Safety objective: Any adverse reaction related to device
To assess the rate of any adverse reaction related to the study device, any skin irritation or other unforeseen adverse reactions will be recorded.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start15 Mar 2018
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borzoo Farhang, University of Vermont
- Investigators
- Borzoo Farhang, DO, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467230
- Sponsor's protocol ID
- 18-0302
- Status last verified
- Apr 2019
- First submitted
- 27 Feb 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
PubMed 23835792Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.
PubMed 26154185Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
PubMed 27171828Rantanen M, Yli-Hankala A, van Gils M, Ypparila-Wolters H, Takala P, Huiku M, Kymalainen M, Seitsonen E, Korhonen I. Novel multiparameter approach for measurement of nociception at skin incision during general anaesthesia. Br J Anaesth. 2006 Mar;96(3):367-76. doi: 10.1093/bja/ael005. Epub 2006 Jan 23.
PubMed 16431883Loeser JD, Treede RD. The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008 Jul 31;137(3):473-477. doi: 10.1016/j.pain.2008.04.025. Epub 2008 Jun 25. No abstract available.
PubMed 18583048Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.
PubMed 23223772Salo M. Effects of anaesthesia and surgery on the immune response. Acta Anaesthesiol Scand. 1992 Apr;36(3):201-20. doi: 10.1111/j.1399-6576.1992.tb03452.x.
PubMed 1574967Libby P. Inflammation in atherosclerosis. Nature. 2002 Dec 19-26;420(6917):868-74. doi: 10.1038/nature01323.
PubMed 12490960Vallejo R, Hord ED, Barna SA, Santiago-Palma J, Ahmed S. Perioperative immunosuppression in cancer patients. J Environ Pathol Toxicol Oncol. 2003;22(2):139-46. doi: 10.1615/jenvpathtoxoncol.v22.i2.70.
PubMed 14533877Tsuchiya Y, Sawada S, Yoshioka I, Ohashi Y, Matsuo M, Harimaya Y, Tsukada K, Saiki I. Increased surgical stress promotes tumor metastasis. Surgery. 2003 May;133(5):547-55. doi: 10.1067/msy.2003.141.
PubMed 12773983Page GG, Ben-Eliyahu S. The immune-suppressive nature of pain. Semin Oncol Nurs. 1997 Feb;13(1):10-5. doi: 10.1016/s0749-2081(97)80044-7.
PubMed 9048431Crozier TA, Muller JE, Quittkat D, Sydow M, Wuttke W, Kettler D. Effect of anaesthesia on the cytokine responses to abdominal surgery. Br J Anaesth. 1994 Mar;72(3):280-5. doi: 10.1093/bja/72.3.280.
PubMed 8130044Corsi M, Mariconti P, Calvillo L, Falchi M, Tiengo M, Ferrero ME. Influence of inhalational, neuroleptic and local anaesthesia on lymphocyte subset distribution. Int J Tissue React. 1995;17(5-6):211-7.
PubMed 8835632
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of the PMD-200 in Subjects Requiring Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03467230
- Acronym / sponsor ID
- 18-0302
- Conditions
- Pain, Opioid Use, Intraoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 15 Mar 2018 (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.
A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a combination of nociception-related physiologic variables, which estimates the nociceptive/antinociceptive state.
The purpose of this project is to conduct an observational study of the PMD-200 noninvasive monitor (Medasense Biometrics Ltd., Ramat Gan, Israel), As this is an observational study, this monitor will not be used for clinical decision making, and the point of the study is to assess what happens with the NoL index during routine care. After thorough discussion with patients and written informed consent is provided in the pre-operative unit, patients will be transferred to the operating room. Patients will be connected to a vital sign monitor and any other medical equipment needed for the surgical procedure, as required by the standard of practice. The PMD-200 finger probe will be connected to the left hand middle finger (or right). The PMD-200 will be activated after the induction of general anesthesia. A calibration period of 1-2 minutes will be performed. At the conclusion of the surgical procedure, the PMD200 will be disconnected from the patient.
All the phases of anesthetic care are performed at the discretion of the anesthesiologist, but the time of administration of analgesics, muscle relaxants and other medications during anesthetic care will be recorded. The investigators will also record the time point of intubation (placement of breathing tube), extubation (removal of breathing tube), skin incision and any other significant surgical stimulation or noxious stimulation during the procedure. The investigators will be comparing NOL values prior to and following noxious stimuli, administration of analgesic agents and during non-noxious periods.
Detailed description
The primary efficacy objective of this study is to demonstrate that the NOL Index of the PMD-200 monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) is correlated with the responses to noxious stimuli and analgesic administration during the surgical procedure (prior and following a stimuli or titration), and the secondary efficacy objective of the study is to determine whether the NOL values can be correlated to other nociception predictors (e.g., increase in heart rate or blood pressure) following a noxious stimuli. The primary safety objective of this study is to assess the rate of any adverse reaction related to the study device. This device will not be used to make any clinical decision.
General anesthesia is the combination of various components including lack of movement, hypnosis, amnesia, control of autonomic responses, and attenuation of the response to noxious stimulation. Some anesthetic components, such as muscle relaxation and absence of movement are easy to assess with a twitch monitor. Similarly, hypnotic state can be estimated using processed electroencephalographic signals, but the anesthetic component that remains the most challenging to assess is the nociceptive/antinociceptive state. Typically, intraoperative nociception is estimated from autonomic responses (such as change in blood pressure and heart rate) and clinical signs such as tearing and sweating, but these variables can be very unreliable in predicting pain such as in patients who take beta blockers for treatment of high blood pressure whose heart rate may not increase in response to pain, patients with significant bleeding during surgery whose blood pressure may not increase in response to pain, etc. Effective antinociception is an important component of balanced anesthesia and appears to enhance postoperative outcomes. The most obvious potential consequence of insufficient intraoperative antinociceptive treatment is excessive postoperative pain, but inadequate treatment may also promote inflammatory, hormonal, and immunologic imbalances.
A novel measure of nociception is the nociception level (NoL) index. The NoL index ranges from 0 to 100 and is based on a nonlinear combination of nociception-related physiologic variables, specifically heart rate (HR), heart rate variability at the 0.15- to 0.4-Hz band power, photoplethysmograph wave amplitude (PPGA), skin conductance level, number of skin conductance fluctuations, and their time derivatives. The NoL index estimates the nociceptive/antinociceptive state from these components measures using random forest regression. Previous experimental work on a small number of patients showed that the NoL index is superior to each individual component and to a linear combination of the components. However, it remains unknown whether the NoL index accurately quantifies patients' intraoperative responses to noxious stimuli of varying intensities. The investigators therefore wish to evaluate the ability of the NoL index to discriminate noxious from nonnoxious stimuli, respond to analgesic administration, and progressively increase in response to increasing intensity of noxious stimulation.
In this observational study, The investigators attempt to learn the proper use of the PMD-200 and assess safety and efficacy of this device as mentioned above; however, no clinical decision will be based on the NoL index obtained.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NoL Index | – | Device: NoL IndexAll patients will be monitored by PMD-200 device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients ASA I-III scheduled for general anesthesia for laparoscopic GI or GU procedures.
Key inclusion criteria (3 listed)
- Age > 18 years old.
- Requiring laparoscopic gastrointestinal or laparoscopic hysterectomy under general anesthesia (without regional anesthesia)
- Patient provides informed consent
Key exclusion criteria (2 listed)
- History of severe cardiac arrhythmias within the last 12 months
- Chronic pain conditions or analgesic usage (>1 month of large doses of opioids: more than 30mg oral equivalent of morphine)
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 |
|---|---|---|
| NoL IndexUse of the PMD-200 in an observational study | Device | NoL Index |
Primary outcome
The primary efficacy objective: Correlation of NoL Index with noxious stimulation/analgesic use
Time frame: Intraoperatively
To demonstrate that the NOL Index of the PMD-200 monitor (Medasense Biometrics Ltd., Ramat Gan, Israel) is correlated with the responses to noxious stimuli and analgesic administration during the surgical procedure (prior and following a stimuli or titration). Specifically, the investigators will assess the % change from baseline-steady state NoL Index value with the NoL Index value during surgical stimulation (increased noxious stimulation) as well as the NoL Index value after administration of analgesics (decreased noxious stimulation).
3 secondary outcomes
the secondary efficacy objective: Correlation of NoL Index with changes in heart rate
Time frame: Intraoperatively
the secondary efficacy objective: Correlation of NoL Index with blood pressure
Time frame: Intraoperatively
Safety objective: Any adverse reaction related to device
Time frame: Intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 23835792Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
- Background: PubMed 26154185Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.
- Background: PubMed 27171828Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
- Background: PubMed 16431883Rantanen M, Yli-Hankala A, van Gils M, Ypparila-Wolters H, Takala P, Huiku M, Kymalainen M, Seitsonen E, Korhonen I. Novel multiparameter approach for measurement of nociception at skin incision during general anaesthesia. Br J Anaesth. 2006 Mar;96(3):367-76. doi: 10.1093/bja/ael005. Epub 2006 Jan 23.
- Background: PubMed 18583048Loeser JD, Treede RD. The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008 Jul 31;137(3):473-477. doi: 10.1016/j.pain.2008.04.025. Epub 2008 Jun 25. No abstract available.
- Background: PubMed 23223772Le Guen M, Liu N, Bourgeois E, Chazot T, Sessler DI, Rouby JJ, Fischler M. Automated sedation outperforms manual administration of propofol and remifentanil in critically ill patients with deep sedation: a randomized phase II trial. Intensive Care Med. 2013 Mar;39(3):454-62. doi: 10.1007/s00134-012-2762-2. Epub 2012 Dec 6.
- Background: PubMed 1574967Salo M. Effects of anaesthesia and surgery on the immune response. Acta Anaesthesiol Scand. 1992 Apr;36(3):201-20. doi: 10.1111/j.1399-6576.1992.tb03452.x.
- Background: PubMed 12490960Libby P. Inflammation in atherosclerosis. Nature. 2002 Dec 19-26;420(6917):868-74. doi: 10.1038/nature01323.
- Background: PubMed 14533877Vallejo R, Hord ED, Barna SA, Santiago-Palma J, Ahmed S. Perioperative immunosuppression in cancer patients. J Environ Pathol Toxicol Oncol. 2003;22(2):139-46. doi: 10.1615/jenvpathtoxoncol.v22.i2.70.
- Background: PubMed 12773983Tsuchiya Y, Sawada S, Yoshioka I, Ohashi Y, Matsuo M, Harimaya Y, Tsukada K, Saiki I. Increased surgical stress promotes tumor metastasis. Surgery. 2003 May;133(5):547-55. doi: 10.1067/msy.2003.141.
- Background: PubMed 9048431Page GG, Ben-Eliyahu S. The immune-suppressive nature of pain. Semin Oncol Nurs. 1997 Feb;13(1):10-5. doi: 10.1016/s0749-2081(97)80044-7.
- Background: PubMed 8130044Crozier TA, Muller JE, Quittkat D, Sydow M, Wuttke W, Kettler D. Effect of anaesthesia on the cytokine responses to abdominal surgery. Br J Anaesth. 1994 Mar;72(3):280-5. doi: 10.1093/bja/72.3.280.
- Individual participant dataSharing planned: Undecided
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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.
Borzoo Farhang, DO principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Opioid Use, run by University of Vermont 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 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy objective: Correlation of NoL Index with noxious stimulation/analgesic use (time frame: Intraoperatively). 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 NCT03467230, which also lists 13 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 17 Apr 2019.