Olfactory ImpairmentNCT06082193
Olfactory Cleft Stenosis and Obstruction on Paranasal Sinus CT Scan in Pre Septo Rhinoplasty Patients Without Respiratory Mucosa Pathology : Normal Variants or Pathologic Findings ?
An observational study of Olfactory Impairment, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
This retrospective studed included patients referred to our institution between December 2013 and december 2021 for septoplasty or septorhinoplasty. All patients underwent pre operatory paranasal sinus CT scan and olfactory test. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Olfactory Impairment
- How many people
- 75 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Aug 2023to 25 Oct 2023
- 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: - Patients over 18 years old who underwent paranasal sinus CT and olfactory test before septoplasty or septorhinoplasty without respiratory mucosa pathology Sex, mean age Olfactory test threshold and identification using sniffin stick test. Classification normosmic or hyposmic using Hummel table.
Who may be able to join
- Patients over 18 years old who underwent paranasal sinus CT and olfactory test before septoplasty or septorhinoplasty
Who cannot join
- Respiratory mucosa pathology on CT (polyposis, opacification of the maxillary sinuses, ethmoid cells, frontal sinus, sphenoidal sinus, sinonasal tumor)
- septal perforation
- chronic respiratory rhinitis (allergic, vasomotor, mucoviscidosis)
- pathologie that can alter olfaction (multiple sclerosis, meningioma, post infection such as COVID)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Jankowski Roger
Nancy, 54000
baptiste deyrail, 0765692558, baptiste.deyrail1@gmail.com
- Recruiting
Centre Hospitalier Régional Universitaire - Service ORL
Nancy
Roger Jankowski, MD/PhD, 0383155408, r.jankowski@chru-nancy.fr
About this study
This retrospective studed included patients referred to our institution between December 2013 and december 2021 for septoplasty or septorhinoplasty. All patients underwent pre operatory paranasal sinus CT scan and olfactory test. Olfacory cleft stenosis will be quoted as none (less than 1/3 contact between nasal septum and ethmoïd turbinates), partial (1/3-2/3 contact between nasal septum and turbinates) or total (more than 2/3 contact between nasal septum and turbinates), as well as Olfactory Cleft obstruction as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).
Read the detailed description
In this retrospective study, We will include every patients over 18 years old who had a septoplasty or septorhinoplasty between December 2013 and December 2021 and who underwent paranasal CT scan and olfactory test (sniffin stick test).
The patients will be find thanks to social security code GAMA007 for septoplastie, GAMA 004, 010 for septorhinoplasty and olfactometry GJQP001.
The patients with mucosa pathology on CT scan or with record of chronic respiratory rhinitis, septum perforation or a pathology that can alter the olfaction on the consultation report will be excluded.
Olfactory measurements were performed before surgery using the threshold and identification subtests of Sniffin Stick Test. Olfactory status will be classified by taking into account the normative data provided by Hummel et al and the real identification score. The patients will be classified as normosmic if the threshold and the identification score is superior the tenth percentile. If not, they will be classified as anosmic if both score are 0 and hyposmic otherwise.
2 experienced radiologists will perform the measures on paranasal sinus CT. They will be blinded to olfactory results.
The olfactory cleft boundaries were determined in the coronal plane : Anterior boundary was defined by the anterior attachment of the middle turbinate; the posterior boundary corresponding to the anterior face of the sphenoid sinus; the lateral boundaries were defined as the attachment of the middle and/or superior turbinate laterally and the nasal septum medially. Olfactory clefts were divided into an anterior and a posterior compartment, defined as "middle olfactory recess" and "superior olfactory recess", laterally bounded by the middle and the superior turbinate lamella, respectively.
Each olfactory recess width, global olfactory Cleft width and cribriform plate width will be measured in the coronal plane, at the level of the cribriform plate and 5mm underneath at 5 different sites :
- - First slice depicting the cribriform plate (entry of the middle olfactory recess)
- - Middle of the middle olfactory recess (halfway throuh 1 and 3)
- - First slice depicting the head of the superior turbinate (entry of the superior olfactory recess)
- - Middle of the superior olfactory recess (halfway through 3 and 5)
- - Anterior face of sphenoid sinus Olfactory cleft length will be determined in the sagittal plane as length of the cribriform plate.
Olfacory cleft stenosis will be quoted as none (less than 1/3 contact between nasal septum and ethmoïd turbinates), partial (1/3-2/3 contact between nasal septum and turbinates) or total (more than 2/3 contact between nasal septum and turbinates), A global olfactory cleft status will be obtained : no significant or partial stenosis in any compartment, total stenosis in case of complete stenosis in every compartment and intermediate stenosis in any other situation.
Olfactory Cleft obstruction will be classified as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).
Olfactory cleft lateral boundaries will be evaluated for the presence of a lamellar pneumatization (superior, middle or lamellar concha bullosa).
Olfactory groove depth was classified according to the Keros classification in regard of the middle and superior olfactory recess.
as well as Olfactory Cleft obstruction as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).
- Conditions
- Olfactory Impairment
- Keywords
- Olfactory Cleft stenosis, Sniffin stick test, Non mucosa pathology, Olfactory recess, Olfactory Cleft Obstruction, Olfactory normal variant
- Medical subject headings
- Olfaction Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Olfactory cleft stenosis or obstruction
Measures will classify as none, partial or total stenosis or obstruction
Measured: 1 day
Secondary outcomes (1)
Impact of olfactory cleft stenosis or obstruction
Are patients with stenosis or obstruction hypsomic or anosmic
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Aug 2023
- Primary completion8 Oct 2023 (estimated)
- Study completion25 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Olfactory ImpairmentStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JANKOWSKI Roger, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082193
- Sponsor's protocol ID
- 2023PI023
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The initial database of patients with olfactory measure and septoplasty or septorhinoplasty can be used for other research as well the one with the patients included (without mucosa pathology)
Publications
Jafek BW, Murrow B, Michaels R, Restrepo D, Linschoten M. Biopsies of human olfactory epithelium. Chem Senses. 2002 Sep;27(7):623-8. doi: 10.1093/chemse/27.7.623.
PubMed 12200342Leboucq N, Menjot de Champfleur N, Menjot de Champfleur S, Bonafe A. The olfactory system. Diagn Interv Imaging. 2013 Oct;94(10):985-91. doi: 10.1016/j.diii.2013.06.006. Epub 2013 Aug 7.
PubMed 23932763Biacabe B, Faulcon P, Amanou L, Bonfils P. Olfactory cleft disease: an analysis of 13 cases. Otolaryngol Head Neck Surg. 2004 Feb;130(2):202-8. doi: 10.1016/j.otohns.2003.09.002.
PubMed 14990917Jankowski R, Rumeau C, Gallet P, Nguyen DT, Russel A, Toussaint B. Endoscopic surgery of the olfactory cleft. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Apr;135(2):137-141. doi: 10.1016/j.anorl.2017.09.005. Epub 2017 Oct 23.
PubMed 29074286Jankowski R, Nguyen DT, Gallet P, Rumeau C. Olfactory cleft dilatation. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Dec;135(6):437-441. doi: 10.1016/j.anorl.2018.05.008. Epub 2018 Jun 20.
PubMed 29934261Jiang RS, Liang KL. The Effect of Endoscopic Olfactory Cleft Opening on Obstructed Olfactory Cleft Disease. Int J Otolaryngol. 2020 Mar 27;2020:8073726. doi: 10.1155/2020/8073726. eCollection 2020.
PubMed 32292482Kuperan AB, Lieberman SM, Jourdy DN, Al-Bar MH, Goldstein BJ, Casiano RR. The effect of endoscopic olfactory cleft polyp removal on olfaction. Am J Rhinol Allergy. 2015 Jul-Aug;29(4):309-13. doi: 10.2500/ajra.2015.29.4191.
PubMed 26163252Nguyen DT, Bey A, Arous F, Nguyen-Thi PL, Felix-Ravelo M, Jankowski R. Can surgeons predict the olfactory outcomes after endoscopic surgery for nasal polyposis? Laryngoscope. 2015 Jul;125(7):1535-40. doi: 10.1002/lary.25223. Epub 2015 Mar 5.
PubMed 25752823Nguyen DT, Gauchotte G, Nguyen-Thi PL, Jankowski R. Does surgery of the olfactory clefts modify the sense of smell? Am J Rhinol Allergy. 2013 Jul-Aug;27(4):317-21. doi: 10.2500/ajra.2013.27.3907.
PubMed 23883814Chang H, Lee HJ, Mo JH, Lee CH, Kim JW. Clinical implication of the olfactory cleft in patients with chronic rhinosinusitis and olfactory loss. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):988-92. doi: 10.1001/archoto.2009.140.
PubMed 19841336Kohli P, Schlosser RJ, Storck K, Soler ZM. Olfactory cleft computed tomography analysis and olfaction in chronic rhinosinusitis. Am J Rhinol Allergy. 2016 Nov 1;30(6):402-406. doi: 10.2500/ajra.2016.30.4365.
PubMed 28124650Loftus C, Schlosser RJ, Smith TL, Alt JA, Ramakrishnan VR, Mattos JL, Mappus E, Storck K, Yoo F, Soler ZM. Olfactory cleft and sinus opacification differentially impact olfaction in chronic rhinosinusitis. Laryngoscope. 2020 Oct;130(10):2311-2318. doi: 10.1002/lary.28332. Epub 2019 Oct 11.
PubMed 31603563Soler ZM, Pallanch JF, Sansoni ER, Jones CS, Lawrence LA, Schlosser RJ, Mace JC, Smith TL. Volumetric computed tomography analysis of the olfactory cleft in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2015 Sep;5(9):846-54. doi: 10.1002/alr.21552. Epub 2015 May 26.
PubMed 26010298Eliezer M, Hamel AL, Houdart E, Herman P, Housset J, Jourdaine C, Eloit C, Verillaud B, Hautefort C. Loss of smell in patients with COVID-19: MRI data reveal a transient edema of the olfactory clefts. Neurology. 2020 Dec 8;95(23):e3145-e3152. doi: 10.1212/WNL.0000000000010806. Epub 2020 Sep 11.
PubMed 32917809Altundag A, Yildirim D, Tekcan Sanli DE, Cayonu M, Kandemirli SG, Sanli AN, Arici Duz O, Saatci O. Olfactory Cleft Measurements and COVID-19-Related Anosmia. Otolaryngol Head Neck Surg. 2021 Jun;164(6):1337-1344. doi: 10.1177/0194599820965920. Epub 2020 Oct 13.
PubMed 33045908
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Cleft Stenosis and Obstruction on Paranasal Sinus CT Scan in Pre Septo Rhinoplasty Patients Without Respiratory Mucosa Pathology : Normal Variants or Pathologic Findings ?
- ClinicalTrials.gov ID
- NCT06082193
- Acronym / sponsor ID
- 2023PI023
- Conditions
- Olfactory Impairment
- Keywords
- Olfactory Cleft stenosis, Sniffin stick test, Non mucosa pathology, Olfactory recess, Olfactory Cleft Obstruction, Olfactory normal variant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 8 Oct 2023 (estimated)
- Study completion
- 25 Oct 2023 (estimated)
- First posted
- 13 Oct 2023 (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 retrospective studed included patients referred to our institution between December 2013 and december 2021 for septoplasty or septorhinoplasty. All patients underwent pre operatory paranasal sinus CT scan and olfactory test. Olfacory cleft stenosis will be quoted as none (less than 1/3 contact between nasal septum and ethmoïd turbinates), partial (1/3-2/3 contact between nasal septum and turbinates) or total (more than 2/3 contact between nasal septum and turbinates), as well as Olfactory Cleft obstruction as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).
Detailed description
In this retrospective study, We will include every patients over 18 years old who had a septoplasty or septorhinoplasty between December 2013 and December 2021 and who underwent paranasal CT scan and olfactory test (sniffin stick test).
The patients will be find thanks to social security code GAMA007 for septoplastie, GAMA 004, 010 for septorhinoplasty and olfactometry GJQP001.
The patients with mucosa pathology on CT scan or with record of chronic respiratory rhinitis, septum perforation or a pathology that can alter the olfaction on the consultation report will be excluded.
Olfactory measurements were performed before surgery using the threshold and identification subtests of Sniffin Stick Test. Olfactory status will be classified by taking into account the normative data provided by Hummel et al and the real identification score. The patients will be classified as normosmic if the threshold and the identification score is superior the tenth percentile. If not, they will be classified as anosmic if both score are 0 and hyposmic otherwise.
2 experienced radiologists will perform the measures on paranasal sinus CT. They will be blinded to olfactory results.
The olfactory cleft boundaries were determined in the coronal plane : Anterior boundary was defined by the anterior attachment of the middle turbinate; the posterior boundary corresponding to the anterior face of the sphenoid sinus; the lateral boundaries were defined as the attachment of the middle and/or superior turbinate laterally and the nasal septum medially. Olfactory clefts were divided into an anterior and a posterior compartment, defined as "middle olfactory recess" and "superior olfactory recess", laterally bounded by the middle and the superior turbinate lamella, respectively.
Each olfactory recess width, global olfactory Cleft width and cribriform plate width will be measured in the coronal plane, at the level of the cribriform plate and 5mm underneath at 5 different sites :
- - First slice depicting the cribriform plate (entry of the middle olfactory recess)
- - Middle of the middle olfactory recess (halfway throuh 1 and 3)
- - First slice depicting the head of the superior turbinate (entry of the superior olfactory recess)
- - Middle of the superior olfactory recess (halfway through 3 and 5)
- - Anterior face of sphenoid sinus Olfactory cleft length will be determined in the sagittal plane as length of the cribriform plate.
Olfacory cleft stenosis will be quoted as none (less than 1/3 contact between nasal septum and ethmoïd turbinates), partial (1/3-2/3 contact between nasal septum and turbinates) or total (more than 2/3 contact between nasal septum and turbinates), A global olfactory cleft status will be obtained : no significant or partial stenosis in any compartment, total stenosis in case of complete stenosis in every compartment and intermediate stenosis in any other situation.
Olfactory Cleft obstruction will be classified as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).
Olfactory cleft lateral boundaries will be evaluated for the presence of a lamellar pneumatization (superior, middle or lamellar concha bullosa).
Olfactory groove depth was classified according to the Keros classification in regard of the middle and superior olfactory recess.
as well as Olfactory Cleft obstruction as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Patients over 18 years old who underwent paranasal sinus CT and olfactory test before septoplasty or septorhinoplasty without respiratory mucosa pathology Sex, mean age Olfactory test threshold and identification using sniffin stick test. Classification normosmic or hyposmic using Hummel table.
Key inclusion criteria (1 listed)
- Patients over 18 years old who underwent paranasal sinus CT and olfactory test before septoplasty or septorhinoplasty
Key exclusion criteria (4 listed)
- Respiratory mucosa pathology on CT (polyposis, opacification of the maxillary sinuses, ethmoid cells, frontal sinus, sphenoidal sinus, sinonasal tumor)
- septal perforation
- chronic respiratory rhinitis (allergic, vasomotor, mucoviscidosis)
- pathologie that can alter olfaction (multiple sclerosis, meningioma, post infection such as COVID)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Olfactory cleft stenosis or obstruction
Time frame: 1 day
Measures will classify as none, partial or total stenosis or obstruction
1 secondary outcome
Impact of olfactory cleft stenosis or obstruction
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Background: PubMed 12200342Jafek BW, Murrow B, Michaels R, Restrepo D, Linschoten M. Biopsies of human olfactory epithelium. Chem Senses. 2002 Sep;27(7):623-8. doi: 10.1093/chemse/27.7.623.
- Background: PubMed 23932763Leboucq N, Menjot de Champfleur N, Menjot de Champfleur S, Bonafe A. The olfactory system. Diagn Interv Imaging. 2013 Oct;94(10):985-91. doi: 10.1016/j.diii.2013.06.006. Epub 2013 Aug 7.
- Background: PubMed 14990917Biacabe B, Faulcon P, Amanou L, Bonfils P. Olfactory cleft disease: an analysis of 13 cases. Otolaryngol Head Neck Surg. 2004 Feb;130(2):202-8. doi: 10.1016/j.otohns.2003.09.002.
- Background: PubMed 29074286Jankowski R, Rumeau C, Gallet P, Nguyen DT, Russel A, Toussaint B. Endoscopic surgery of the olfactory cleft. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Apr;135(2):137-141. doi: 10.1016/j.anorl.2017.09.005. Epub 2017 Oct 23.
- Background: PubMed 29934261Jankowski R, Nguyen DT, Gallet P, Rumeau C. Olfactory cleft dilatation. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Dec;135(6):437-441. doi: 10.1016/j.anorl.2018.05.008. Epub 2018 Jun 20.
- Background: PubMed 32292482Jiang RS, Liang KL. The Effect of Endoscopic Olfactory Cleft Opening on Obstructed Olfactory Cleft Disease. Int J Otolaryngol. 2020 Mar 27;2020:8073726. doi: 10.1155/2020/8073726. eCollection 2020.
- Background: PubMed 26163252Kuperan AB, Lieberman SM, Jourdy DN, Al-Bar MH, Goldstein BJ, Casiano RR. The effect of endoscopic olfactory cleft polyp removal on olfaction. Am J Rhinol Allergy. 2015 Jul-Aug;29(4):309-13. doi: 10.2500/ajra.2015.29.4191.
- Background: PubMed 25752823Nguyen DT, Bey A, Arous F, Nguyen-Thi PL, Felix-Ravelo M, Jankowski R. Can surgeons predict the olfactory outcomes after endoscopic surgery for nasal polyposis? Laryngoscope. 2015 Jul;125(7):1535-40. doi: 10.1002/lary.25223. Epub 2015 Mar 5.
- Background: PubMed 23883814Nguyen DT, Gauchotte G, Nguyen-Thi PL, Jankowski R. Does surgery of the olfactory clefts modify the sense of smell? Am J Rhinol Allergy. 2013 Jul-Aug;27(4):317-21. doi: 10.2500/ajra.2013.27.3907.
- Background: PubMed 19841336Chang H, Lee HJ, Mo JH, Lee CH, Kim JW. Clinical implication of the olfactory cleft in patients with chronic rhinosinusitis and olfactory loss. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):988-92. doi: 10.1001/archoto.2009.140.
- Background: PubMed 28124650Kohli P, Schlosser RJ, Storck K, Soler ZM. Olfactory cleft computed tomography analysis and olfaction in chronic rhinosinusitis. Am J Rhinol Allergy. 2016 Nov 1;30(6):402-406. doi: 10.2500/ajra.2016.30.4365.
- Background: PubMed 31603563Loftus C, Schlosser RJ, Smith TL, Alt JA, Ramakrishnan VR, Mattos JL, Mappus E, Storck K, Yoo F, Soler ZM. Olfactory cleft and sinus opacification differentially impact olfaction in chronic rhinosinusitis. Laryngoscope. 2020 Oct;130(10):2311-2318. doi: 10.1002/lary.28332. Epub 2019 Oct 11.
- Individual participant dataSharing planned: Undecided. The initial database of patients with olfactory measure and septoplasty or septorhinoplasty can be used for other research as well the one with the patients included (without mucosa pathology)
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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.
Centre Hospitalier Régional Universitaire - Service ORL
Nancy, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Olfactory Impairment, run by Central Hospital, Nancy, France at 2 sites in France.
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 1 inclusion and 4 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 13 Oct 2023. 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory cleft stenosis or obstruction (time frame: 1 day). 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 NCT06082193, which also lists 23 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 13 Oct 2023.