AchalasiaNCT03702647
Ropivacaine For Post-POEM Pain Control
A study testing Ropivacaine and Normal saline in people with Achalasia and Esophageal Achalasia, run by Lawrence Charles Hookey at 1 site in Canada.
Trial summary
POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax.The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia, Esophageal Achalasia
- What is being tested?
- Ropivacaine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2019to 18 Jan 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older undergoing POEM procedure
- Able to provide written informed consent
- Fluent and literate in English
Who cannot join
- Patients with known adverse reactions to local anesthetics and NSAIDs (GFR<50)
- Patients with chronic pain taking regular analgesics or narcotics (requiring daily opioid therapy > 30 mg morphine or equivalents)
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax.The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms.This study seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications.
Read the detailed description
POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax. Consequently, patients experience difficulty swallowing, reflux, and weight loss. Treatment options for achalasia are generally divided into 2 categories: A) treatment with medication, or B) treatment via a procedure. Medical treatment is generally reserved for patients to unwell to undergo procedures as the efficacy is low. Additionally, patients tend to experience many side-effects. There are also procedural options used to treat achalasia which include surgical myotomy and POEM. The POEM procedure is advantageous because it is less invasive, but is at least as equally effective for symptomatic relief when compared to the surgical myotomy. The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms. At the conclusion of the procedure, clips are placed in the esophagus to close the incision. Currently, patients are given intravenous ketorolac, oral viscous lidocaine and narcotic analgesics as needed to manage post-operative pain. This study, however, seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications. Patients consented to participate in the study will be randomized to receive either ropivacaine (intervention group) or saline (control group). Pain will be assessed at 0.5, 1, 2, 4, and 6 hours post-admission to the recovery unit using validated pain scales. Additionally, the Quality of Recovery (QoR-15) patient survey, will be completed prior to discharge. This measure will capture the patient's initial post-operative health condition and help capture the overall patient experience.
- Conditions
- Achalasia, Esophageal Achalasia
- Being tested
- Ropivacaine, Normal saline
- Keywords
- Peroral Endoscopic Myotomy, Ropivacaine, Post-procedure pain control
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
30mL of 0.2% Ropivacaine placed in the POEM tunnel
Normal salineDrug
30mL of normal saline placed in the POEM tunnel
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | 30mL of 0.2% Ropivacaine placed in the POEM tunnel Receives: Drug: Ropivacaine |
| Normal Saline | Placebo comparator | 30mL of normal saline placed in the POEM tunnel Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-POEM pain level
To assess the effect of the intervention/placebo on pain 6-hours post-POEM as assessed via the Numeric Rating Scale (NRS): The patient will be asked to rate their pain on a scale of 0-10, 0 representing no pain, and 10 representing the worst pain they have ever felt in their life.
Measured: 6 hours post-POEM procedure
Secondary outcomes (6)
Post-POEM pain level
Assessing pain scores at 0, 0.5, 1, 2, 4 hours post-POEM and on discharge
Measured: 0, 0.5, 1, 2, 4 hours post-POEM procedure
Quality of Recovery (QoR-15) score on the day of discharge
Quality of Recovery-15 score: This survey captures patient's initial post-operative health condition and their overall patient experience. The patient will be asked to rate various emotional and physical aspects of their post-operative condition on a scale of 0-10. 0 will represent an emotion or activity experienced or accomplished none of the time, and 10 will represent an emotion or activity accomplished all of the time. Scores are summed; higher scores indicate a more optimal post-operative condition.
Measured: Assessed up to 24 hours post-POEM procedure
Post-POEM analgesic
The requirement of post-POEM analgesic
Measured: 0 -6 hours post-procedure
Adverse Events
Adverse events in hospital
Measured: Assessed up to 24 hours post-POEM procedure
Fentanyl consumption
Intraprocedural fentanyl consumption
Measured: Intra-procedure
Repeatability of procedure
Patient's willingness to have the procedure done on an outpatient basis: Patients will be asked if they are "willing" or "not willing" to have the procedure done on an outpatient basis.
Measured: Assessed 24 hours post-POEM procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Jun 2019
- Primary completion1 Dec 2020
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled in the study will be randomized to receive either 30mL of normal saline (placebo), or 30mL of 0.2% ropivacaine in the POEM tunnel.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lawrence Charles Hookey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lawrence Charles Hookey, Queen's University
- Investigators
- Robert Bechara, M.D., Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702647
- Sponsor's protocol ID
- DMED -2186-18
- Status last verified
- Jan 2021
- First submitted
- 4 Oct 2018
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sadowski DC, Ackah F, Jiang B, Svenson LW. Achalasia: incidence, prevalence and survival. A population-based study. Neurogastroenterol Motil. 2010 Sep;22(9):e256-61. doi: 10.1111/j.1365-2982.2010.01511.x. Epub 2010 May 11.
PubMed 20465592Samo S, Carlson DA, Gregory DL, Gawel SH, Pandolfino JE, Kahrilas PJ. Incidence and Prevalence of Achalasia in Central Chicago, 2004-2014, Since the Widespread Use of High-Resolution Manometry. Clin Gastroenterol Hepatol. 2017 Mar;15(3):366-373. doi: 10.1016/j.cgh.2016.08.030. Epub 2016 Aug 28.
PubMed 27581064Goyal RK, Chaudhury A. Physiology of normal esophageal motility. J Clin Gastroenterol. 2008 May-Jun;42(5):610-9. doi: 10.1097/MCG.0b013e31816b444d.
PubMed 18364578Goyal RK, Chaudhury A. Pathogenesis of achalasia: lessons from mutant mice. Gastroenterology. 2010 Oct;139(4):1086-90. doi: 10.1053/j.gastro.2010.08.013. Epub 2010 Aug 25. No abstract available.
PubMed 20800108Clark SB, Rice TW, Tubbs RR, Richter JE, Goldblum JR. The nature of the myenteric infiltrate in achalasia: an immunohistochemical analysis. Am J Surg Pathol. 2000 Aug;24(8):1153-8. doi: 10.1097/00000478-200008000-00014.
PubMed 10935657Robertson CS, Martin BA, Atkinson M. Varicella-zoster virus DNA in the oesophageal myenteric plexus in achalasia. Gut. 1993 Mar;34(3):299-302. doi: 10.1136/gut.34.3.299.
PubMed 8386130Castagliuolo I, Brun P, Costantini M, Rizzetto C, Palu G, Costantino M, Baldan N, Zaninotto G. Esophageal achalasia: is the herpes simplex virus really innocent? J Gastrointest Surg. 2004 Jan;8(1):24-30; discussion 30. doi: 10.1016/j.gassur.2003.10.004.
PubMed 14746832Niwamoto H, Okamoto E, Fujimoto J, Takeuchi M, Furuyama J, Yamamoto Y. Are human herpes viruses or measles virus associated with esophageal achalasia? Dig Dis Sci. 1995 Apr;40(4):859-64. doi: 10.1007/BF02064992.
PubMed 7720482Birgisson S, Galinski MS, Goldblum JR, Rice TW, Richter JE. Achalasia is not associated with measles or known herpes and human papilloma viruses. Dig Dis Sci. 1997 Feb;42(2):300-6. doi: 10.1023/a:1018805600276.
PubMed 9052510Verne GN, Sallustio JE, Eaker EY. Anti-myenteric neuronal antibodies in patients with achalasia. A prospective study. Dig Dis Sci. 1997 Feb;42(2):307-13. doi: 10.1023/a:1018857617115.
PubMed 9052511Kallel-Sellami M, Karoui S, Romdhane H, Laadhar L, Serghini M, Boubaker J, Lahmar H, Filali A, Makni S. Circulating antimyenteric autoantibodies in Tunisian patients with idiopathic achalasia. Dis Esophagus. 2013 Nov-Dec;26(8):782-7. doi: 10.1111/j.1442-2050.2012.01398.x. Epub 2012 Sep 4.
PubMed 22947106Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol. 2013 Aug;108(8):1238-49; quiz 1250. doi: 10.1038/ajg.2013.196. Epub 2013 Jul 23.
PubMed 23877351Schlottmann F, Herbella F, Allaix ME, Patti MG. Modern management of esophageal achalasia: From pathophysiology to treatment. Curr Probl Surg. 2018 Jan;55(1):10-37. doi: 10.1067/j.cpsurg.2018.01.001. Epub 2018 Jan 31. No abstract available.
PubMed 29548347Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
PubMed 20354937Schlottmann F, Luckett DJ, Fine J, Shaheen NJ, Patti MG. Laparoscopic Heller Myotomy Versus Peroral Endoscopic Myotomy (POEM) for Achalasia: A Systematic Review and Meta-analysis. Ann Surg. 2018 Mar;267(3):451-460. doi: 10.1097/SLA.0000000000002311.
PubMed 28549006
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ropivacaine For Post-POEM Pain Control
- ClinicalTrials.gov ID
- NCT03702647
- Acronym / sponsor ID
- DMED -2186-18
- Conditions
- Achalasia, Esophageal Achalasia
- Keywords
- Peroral Endoscopic Myotomy, Ropivacaine, Post-procedure pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lawrence Charles HookeyUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 11 Oct 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.
POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax.The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms.This study seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications.
Detailed description
POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax. Consequently, patients experience difficulty swallowing, reflux, and weight loss. Treatment options for achalasia are generally divided into 2 categories: A) treatment with medication, or B) treatment via a procedure. Medical treatment is generally reserved for patients to unwell to undergo procedures as the efficacy is low. Additionally, patients tend to experience many side-effects. There are also procedural options used to treat achalasia which include surgical myotomy and POEM. The POEM procedure is advantageous because it is less invasive, but is at least as equally effective for symptomatic relief when compared to the surgical myotomy. The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms. At the conclusion of the procedure, clips are placed in the esophagus to close the incision. Currently, patients are given intravenous ketorolac, oral viscous lidocaine and narcotic analgesics as needed to manage post-operative pain. This study, however, seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications. Patients consented to participate in the study will be randomized to receive either ropivacaine (intervention group) or saline (control group). Pain will be assessed at 0.5, 1, 2, 4, and 6 hours post-admission to the recovery unit using validated pain scales. Additionally, the Quality of Recovery (QoR-15) patient survey, will be completed prior to discharge. This measure will capture the patient's initial post-operative health condition and help capture the overall patient experience.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients enrolled in the study will be randomized to receive either 30mL of normal saline (placebo), or 30mL of 0.2% ropivacaine in the POEM tunnel.
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: Ropivacaine30mL of 0.2% Ropivacaine placed in the POEM tunnel |
| Normal Saline | Placebo comparator | Drug: Normal saline30mL of normal saline placed in the POEM tunnel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older undergoing POEM procedure
- Able to provide written informed consent
- Fluent and literate in English
Key exclusion criteria (3 listed)
- Patients with known adverse reactions to local anesthetics and NSAIDs (GFR<50)
- Patients with chronic pain taking regular analgesics or narcotics (requiring daily opioid therapy > 30 mg morphine or equivalents)
- Patients unable to give informed consent
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 |
|---|---|---|
| Ropivacaine30mL of 0.2% Ropivacaine placed in the POEM tunnel | Drug | Ropivacaine |
| Normal saline30mL of normal saline placed in the POEM tunnel | Drug | Normal Saline |
Primary outcome
Post-POEM pain level
Time frame: 6 hours post-POEM procedure
To assess the effect of the intervention/placebo on pain 6-hours post-POEM as assessed via the Numeric Rating Scale (NRS): The patient will be asked to rate their pain on a scale of 0-10, 0 representing no pain, and 10 representing the worst pain they have ever felt in their life.
6 secondary outcomes
Post-POEM pain level
Time frame: 0, 0.5, 1, 2, 4 hours post-POEM procedure
Quality of Recovery (QoR-15) score on the day of discharge
Time frame: Assessed up to 24 hours post-POEM procedure
Post-POEM analgesic
Time frame: 0 -6 hours post-procedure
Adverse Events
Time frame: Assessed up to 24 hours post-POEM procedure
Fentanyl consumption
Time frame: Intra-procedure
Repeatability of procedure
Time frame: Assessed 24 hours post-POEM procedure
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 26 Jan 2021.
- Background: PubMed 20465592Sadowski DC, Ackah F, Jiang B, Svenson LW. Achalasia: incidence, prevalence and survival. A population-based study. Neurogastroenterol Motil. 2010 Sep;22(9):e256-61. doi: 10.1111/j.1365-2982.2010.01511.x. Epub 2010 May 11.
- Background: PubMed 27581064Samo S, Carlson DA, Gregory DL, Gawel SH, Pandolfino JE, Kahrilas PJ. Incidence and Prevalence of Achalasia in Central Chicago, 2004-2014, Since the Widespread Use of High-Resolution Manometry. Clin Gastroenterol Hepatol. 2017 Mar;15(3):366-373. doi: 10.1016/j.cgh.2016.08.030. Epub 2016 Aug 28.
- Background: PubMed 18364578Goyal RK, Chaudhury A. Physiology of normal esophageal motility. J Clin Gastroenterol. 2008 May-Jun;42(5):610-9. doi: 10.1097/MCG.0b013e31816b444d.
- Background: PubMed 20800108Goyal RK, Chaudhury A. Pathogenesis of achalasia: lessons from mutant mice. Gastroenterology. 2010 Oct;139(4):1086-90. doi: 10.1053/j.gastro.2010.08.013. Epub 2010 Aug 25. No abstract available.
- Background: PubMed 10935657Clark SB, Rice TW, Tubbs RR, Richter JE, Goldblum JR. The nature of the myenteric infiltrate in achalasia: an immunohistochemical analysis. Am J Surg Pathol. 2000 Aug;24(8):1153-8. doi: 10.1097/00000478-200008000-00014.
- Background: PubMed 8386130Robertson CS, Martin BA, Atkinson M. Varicella-zoster virus DNA in the oesophageal myenteric plexus in achalasia. Gut. 1993 Mar;34(3):299-302. doi: 10.1136/gut.34.3.299.
- Background: PubMed 14746832Castagliuolo I, Brun P, Costantini M, Rizzetto C, Palu G, Costantino M, Baldan N, Zaninotto G. Esophageal achalasia: is the herpes simplex virus really innocent? J Gastrointest Surg. 2004 Jan;8(1):24-30; discussion 30. doi: 10.1016/j.gassur.2003.10.004.
- Background: PubMed 7720482Niwamoto H, Okamoto E, Fujimoto J, Takeuchi M, Furuyama J, Yamamoto Y. Are human herpes viruses or measles virus associated with esophageal achalasia? Dig Dis Sci. 1995 Apr;40(4):859-64. doi: 10.1007/BF02064992.
- Background: PubMed 9052510Birgisson S, Galinski MS, Goldblum JR, Rice TW, Richter JE. Achalasia is not associated with measles or known herpes and human papilloma viruses. Dig Dis Sci. 1997 Feb;42(2):300-6. doi: 10.1023/a:1018805600276.
- Background: PubMed 9052511Verne GN, Sallustio JE, Eaker EY. Anti-myenteric neuronal antibodies in patients with achalasia. A prospective study. Dig Dis Sci. 1997 Feb;42(2):307-13. doi: 10.1023/a:1018857617115.
- Background: PubMed 22947106Kallel-Sellami M, Karoui S, Romdhane H, Laadhar L, Serghini M, Boubaker J, Lahmar H, Filali A, Makni S. Circulating antimyenteric autoantibodies in Tunisian patients with idiopathic achalasia. Dis Esophagus. 2013 Nov-Dec;26(8):782-7. doi: 10.1111/j.1442-2050.2012.01398.x. Epub 2012 Sep 4.
- Background: PubMed 23877351Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol. 2013 Aug;108(8):1238-49; quiz 1250. doi: 10.1038/ajg.2013.196. Epub 2013 Jul 23.
- Individual participant dataSharing planned: No
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Achalasia
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.
Robert Bechara, M.D. principal investigator
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine and Normal saline in people with Achalasia and Esophageal Achalasia, run by Lawrence Charles Hookey at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 26 Jan 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Post-POEM pain level (time frame: 6 hours post-POEM procedure). 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 NCT03702647, which also lists 18 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 26 Jan 2021.