Knee OsteoarthritisPANDORA1NCT05414617
Safety of Use of Pandora for Patients Suffering From Gonarthrosis
A study testing Intra-articular single injection and Intra-articular three injections in people with Knee Osteoarthritis, run by Labrha at 2 sites in France.
Trial summary
The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intra-articular single injection and Intra-articular three injections
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Jun 2022to 14 Jun 2023
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged between 35 and 85 years.
- Body mass index (BMI) < 30 kg.m^2.
- Medial or lateral femoro-tibial knee osteoarthritis, diagnosed according to the American College of Rheumatology criteria, radiological stage 2 and 3 according to the Kellgren-Lawrence criteria modified by Felson on an X-ray, of the knee in extension, less than 12 months old.
- Knee osteoarthritis responsible for walking pain in the target knee, assessed between 4 and 8 inclusive on an 11 points numerical scale (0 = none to 10 = extreme).
- Ambulatory patient able to walk 50 meters without a cane, crutch or walker.
- Patient able to read, understand, sign and date the patient information sheet.
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- Patient agreeing to follow-up study visits.
- Patient affiliated to the health social security system.
- Patient requiring viscosupplementation according to the investigator.
Who cannot join
- Patient presenting knee osteoarthritis without impingement joint space narrowing of the femoro-tibial compartment (modified Kellgren stage 0-1) or with complete impingement joint space narrowing on the knee weight-bearing radiograph in extension (modified Kellgren stage 4).
- Walking pain in the target knee, rated less than 4 or more than 8 on an 11-point numerical scale (0 = none to 10 = extreme).
- Patient with a flare of osteoarthritis of the target or contralateral knee attested by KOFUS criteria ≥ 7.
- Patient who received viscosupplementation or Platelet Rich Plasma (PRP) injection in the 6 months prior to inclusion.
- Patient who received an intra-articular injection of corticosteroids in the target knee in the 2 months prior to inclusion.
- Patients with a skin condition or a wound next to or near the injection site.
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- Patients refusing to discontinue treatment with NSAIDs or cox-2 inhibitors during the follow-up period.
- Patient receiving treatment with level III analgesics (strong opioids).
- Patients receiving treatment with diacerhein, avocado and soy unsaponifiables, glucosamine or chondroitin initiated less than 2 months prior to inclusion.
- Patient with hypersensitivity to hyaluronic acid or tranexamic acid.
- Patient with a history of seizures.
- Patient who had arthroscopy of the target knee or major trauma to the target knee during the 3 months preceding inclusion.
- Patient scheduled to undergo surgery, for any cause, of the target knee or other joint of the lower limbs, planned within 6 months of inclusion, likely to interfere with follow-up or evaluation of the patient in the study.
- Patient with Fibromyalgia.
- Patient with an active neurological or vascular musculoskeletal disorder (such as rheumatoid arthritis, lupus, psoriatic arthritis, spondyloarthritis or any other autoimmune disease, Paget's disease, gout, coxopathy, tendinopathy of the lower limb, sciatic or crural radiculalgia) that could interfere with the measurement of the effectiveness of the treatment of the knee evaluated.
- Patient with hemostasis disorders, venous or lymphatic stenosis of the lower limbs, history of thromboembolic disease - phlebitis or pulmonary embolism - or a high risk of thromboembolism.
- Patients with an evolving general cardiac, digestive, endocrine, haematological or broncho-pulmonary condition which, in the opinion of the investigator, would be likely to disrupt regular monitoring and/or interfere with the measurement of treatment efficacy .
- Breastfeeding patient, pregnant or wishing to be during the 6 months of the study.
- Patient unable to give personal consent.
- Patient with renal insufficiency.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Nord Franche-Comté, HNFC
Belfort
Groupe Hospitalier de la Région Mulhouse Sud-Alsace, GHRMSA
Mulhouse
About this study
Official title: Prospective, Multicenter, Open Study Evaluating the Short-term Safety of Use of Pandora Administered in the Form of 1 Intra-articular Injection of Happyone or 3 Intra-articular Injections of Happysoft in Patients Suffering From Gonarthrosis
The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies.
The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve mobility. In practice, there are two protocols to administer viscosupplementation : in a single injection or in three injections performed weekly.
The present clinical investigation has the objective to evaluate the safety of use of Pandora in a single injection or in three injections performed weekly.
Read the detailed description
This clinical investigation is a multicenter, prospective, open study of a class III Medical Device.
This study is designed to evaluate the safety of use of Pandora in its two forms : in a single injection or in three injections.
A descriptive analysis will be carried out to characterize the demographic data, the history of the disease and its treatments, the clinical and radiological data of the patients at inclusion.
The security of use of Pandora will be demonstrated by describing the proportion of patients with at least one adverse event attributable to the treatment, occurring during the week following each injection.
In total, 20 participants will be enrolled across two study centers in France, 10 participants in each centers.
The total duration of subjects participation is 6 months ; overall study duration including the enrollment period is expected to take approximately 9 months.
- Conditions
- Knee Osteoarthritis
- Being tested
- Intra-articular single injection, Intra-articular three injections
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular single injectionDevice
Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment.
The injection will be performed at Day 1.
Intra-articular three injectionsDevice
Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment.
The injections will be performed at Days 1, 8 and 15.
| Study group | Role | What they receive |
|---|---|---|
| Medical Device : Happyone | Experimental | Hyaluronic acid associated with tranexamic acid ; 4.8 ml will be injected in one time Receives: Device: Intra-articular single injection |
| Medical Device : Happysoft | Experimental | Hyaluronic acid associated with tranexamic acid ; 2.2 ml will be injected in three times (one injection per week) Receives: Device: Intra-articular three injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse event attributable to the investigational Medical Device during the week following each injection.
Adverse events will be collected at :
- Day 8 for Happyone arm (single injection) ;
- Days 8, 15 and 22 for Happysoft arm (three injections).
Measured: 1 month
Secondary outcomes (4)
Number of adverse events during the month following the first injection for immediate and delayed local tolerance evaluation.
All adverse events will be collected at :
- Days 3, 8, 22 and 29 for Happyone arm (single injection) ;
- Days 3, 8, 10, 15, 17, 22 and 29 for Happysoft arm (three injections). Number of adverse events occurring beyond the week following each injection from Day 1 to D29.
Measured: 1 month
Patient self-assesment of the overall tolerance of the treatment based on a 5-point scale, from "Very bad" to "Very good".
This questionnaire will be completed at :
- Days 3, 8, 22 and 29 for Happyone arm (single injection) ;
- Days 3, 8, 10, 15, 17, 22 and 29 for Happysoft arm (three injections).
Measured: 1 month
Variation over time of the WOMAC score, between time of injection and end point, and the WOMAC subscores A (pain) and C (function). The WOMAC-Questionnaire is based on a 11 points scale, from 0 = None to 10 = Extreme.
This questionnaire will be completed at :
- Day 1, Day 8, Month 1, Month 3 and Month 6 for Happyone arm (single injection) ;
- Day 1, Day 8, Day 15, Month 1, Month 3 and Month 6 for Happysoft arm (three injections).
Measured: 6 months
Patient self-assesment of the effectiveness of the treatment based on a 11 points numeric scale, from 0 = None to 10 = Total.
This questionnaire will be completed at Months 1, 3 and 6 for both groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start8 Jun 2022
- Primary completion18 Jan 2023
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Multi-center, Open Clinical Investigation. Two facilities are participating ; each facility will be in charge and perform a type of viscosupplementation procedure : single injection or three injections. Subjects will received one or the other viscosupplementation depending of the facility in which they will be included.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labrha
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Statitec
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Balblanc, MD, Principal investigator, Hôpital Nord Franche-Comté, HNFC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414617
- Sponsor's protocol ID
- 2021-A01153-38
- Acronym
- PANDORA1
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sellam J, Courties A, Eymard F, Ferrero S, Latourte A, Ornetti P, Bannwarth B, Baumann L, Berenbaum F, Chevalier X, Ea HK, Fabre MC, Forestier R, Grange L, Lellouche H, Maillet J, Mainard D, Perrot S, Rannou F, Rat AC, Roux CH, Senbel E, Richette P; French Society of Rheumatology. Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis. Joint Bone Spine. 2020 Dec;87(6):548-555. doi: 10.1016/j.jbspin.2020.09.004. Epub 2020 Sep 12.
PubMed 32931933Balazs EA. Viscosupplementation for treatment of osteoarthritis: from initial discovery to current status and results. Surg Technol Int. 2004;12:278-89.
PubMed 15455338Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542. doi: 10.1186/s12891-017-1897-2.
PubMed 29268731Diracoglu D, Tuncay TB, Sahbaz T, Aksoy C. Single versus multiple dose hyaluronic acid: Comparison of the results. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):881-886. doi: 10.3233/BMR-160714.
PubMed 27257981Bhadra AK, Altman R, Dasa V, Myrick K, Rosen J, Vad V, Vitanzo P Jr, Bruno M, Kleiner H, Just C. Appropriate Use Criteria for Hyaluronic Acid in the Treatment of Knee Osteoarthritis in the United States. Cartilage. 2017 Jul;8(3):234-254. doi: 10.1177/1947603516662503. Epub 2016 Aug 10.
PubMed 28618868Li J, Liu R, Rai S, Ze R, Tang X, Hong P. Intra-articular vs. intravenous administration: a meta-analysis of tranexamic acid in primary total knee arthroplasty. J Orthop Surg Res. 2020 Dec 2;15(1):581. doi: 10.1186/s13018-020-02119-1.
PubMed 33267906Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23.
PubMed 25797505Jules-Elysee KM, Tseng A, Sculco TP, Baaklini LR, McLawhorn AS, Pickard AJ, Qin W, Cross JR, Su EP, Fields KG, Mayman DJ. Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels. J Bone Joint Surg Am. 2019 Dec 4;101(23):2120-2128. doi: 10.2106/JBJS.19.00258.
PubMed 31800425
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Open Study Evaluating the Short-term Safety of Use of Pandora Administered in the Form of 1 Intra-articular Injection of Happyone or 3 Intra-articular Injections of Happysoft in Patients Suffering From Gonarthrosis
- ClinicalTrials.gov ID
- NCT05414617
- Acronym / sponsor ID
- PANDORA1 / 2021-A01153-38
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- LabrhaIndustry (pharma, biotech, devices)
- Collaborators
- Statitec
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 10 Jun 2022 (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.
The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies.
The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve mobility. In practice, there are two protocols to administer viscosupplementation : in a single injection or in three injections performed weekly.
The present clinical investigation has the objective to evaluate the safety of use of Pandora in a single injection or in three injections performed weekly.
Detailed description
This clinical investigation is a multicenter, prospective, open study of a class III Medical Device.
This study is designed to evaluate the safety of use of Pandora in its two forms : in a single injection or in three injections.
A descriptive analysis will be carried out to characterize the demographic data, the history of the disease and its treatments, the clinical and radiological data of the patients at inclusion.
The security of use of Pandora will be demonstrated by describing the proportion of patients with at least one adverse event attributable to the treatment, occurring during the week following each injection.
In total, 20 participants will be enrolled across two study centers in France, 10 participants in each centers.
The total duration of subjects participation is 6 months ; overall study duration including the enrollment period is expected to take approximately 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Multi-center, Open Clinical Investigation. Two facilities are participating ; each facility will be in charge and perform a type of viscosupplementation procedure : single injection or three injections. Subjects will received one or the other viscosupplementation depending of the facility in which they will be included.
| Arm | Type | Receives |
|---|---|---|
| Medical Device : Happyone | Experimental | Device: Intra-articular single injectionHyaluronic acid associated with tranexamic acid ; 4.8 ml will be injected in one time |
| Medical Device : Happysoft | Experimental | Device: Intra-articular three injectionsHyaluronic acid associated with tranexamic acid ; 2.2 ml will be injected in three times (one injection per week) |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient aged between 35 and 85 years.
- Body mass index (BMI) < 30 kg.m^2.
- Medial or lateral femoro-tibial knee osteoarthritis, diagnosed according to the American College of Rheumatology criteria, radiological stage 2 and 3 according to the Kellgren-Lawrence criteria modified by Felson on an X-ray, of the knee in extension, less than 12 months old.
- Knee osteoarthritis responsible for walking pain in the target knee, assessed between 4 and 8 inclusive on an 11 points numerical scale (0 = none to 10 = extreme).
- Ambulatory patient able to walk 50 meters without a cane, crutch or walker.
Key exclusion criteria (20 listed)
- Patient presenting knee osteoarthritis without impingement joint space narrowing of the femoro-tibial compartment (modified Kellgren stage 0-1) or with complete impingement joint space narrowing on the knee weight-bearing radiograph in extension (modified Kellgren stage 4).
- Walking pain in the target knee, rated less than 4 or more than 8 on an 11-point numerical scale (0 = none to 10 = extreme).
- Patient with a flare of osteoarthritis of the target or contralateral knee attested by KOFUS criteria ≥ 7.
- Patient who received viscosupplementation or Platelet Rich Plasma (PRP) injection in the 6 months prior to inclusion.
- Patient who received an intra-articular injection of corticosteroids in the target knee in the 2 months prior to inclusion.
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 |
|---|---|---|
| Intra-articular single injectionBoth groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. The injection will be performed at Day 1. | Device | Medical Device : Happyone |
| Intra-articular three injectionsBoth groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment. The injections will be performed at Days 1, 8 and 15. | Device | Medical Device : Happysoft |
Primary outcome
Number of adverse event attributable to the investigational Medical Device during the week following each injection.
Time frame: 1 month
Adverse events will be collected at : * Day 8 for Happyone arm (single injection) ; * Days 8, 15 and 22 for Happysoft arm (three injections).
4 secondary outcomes
Number of adverse events during the month following the first injection for immediate and delayed local tolerance evaluation.
Time frame: 1 month
Patient self-assesment of the overall tolerance of the treatment based on a 5-point scale, from "Very bad" to "Very good".
Time frame: 1 month
Variation over time of the WOMAC score, between time of injection and end point, and the WOMAC subscores A (pain) and C (function). The WOMAC-Questionnaire is based on a 11 points scale, from 0 = None to 10 = Extreme.
Time frame: 6 months
Patient self-assesment of the effectiveness of the treatment based on a 11 points numeric scale, from 0 = None to 10 = Total.
Time frame: 6 months
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 22 Jun 2023.
- Background: PubMed 32931933Sellam J, Courties A, Eymard F, Ferrero S, Latourte A, Ornetti P, Bannwarth B, Baumann L, Berenbaum F, Chevalier X, Ea HK, Fabre MC, Forestier R, Grange L, Lellouche H, Maillet J, Mainard D, Perrot S, Rannou F, Rat AC, Roux CH, Senbel E, Richette P; French Society of Rheumatology. Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis. Joint Bone Spine. 2020 Dec;87(6):548-555. doi: 10.1016/j.jbspin.2020.09.004. Epub 2020 Sep 12.
- Background: PubMed 15455338Balazs EA. Viscosupplementation for treatment of osteoarthritis: from initial discovery to current status and results. Surg Technol Int. 2004;12:278-89.
- Background: PubMed 29268731Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542. doi: 10.1186/s12891-017-1897-2.
- Background: PubMed 27257981Diracoglu D, Tuncay TB, Sahbaz T, Aksoy C. Single versus multiple dose hyaluronic acid: Comparison of the results. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):881-886. doi: 10.3233/BMR-160714.
- Background: PubMed 28618868Bhadra AK, Altman R, Dasa V, Myrick K, Rosen J, Vad V, Vitanzo P Jr, Bruno M, Kleiner H, Just C. Appropriate Use Criteria for Hyaluronic Acid in the Treatment of Knee Osteoarthritis in the United States. Cartilage. 2017 Jul;8(3):234-254. doi: 10.1177/1947603516662503. Epub 2016 Aug 10.
- Background: PubMed 33267906Li J, Liu R, Rai S, Ze R, Tang X, Hong P. Intra-articular vs. intravenous administration: a meta-analysis of tranexamic acid in primary total knee arthroplasty. J Orthop Surg Res. 2020 Dec 2;15(1):581. doi: 10.1186/s13018-020-02119-1.
- Background: PubMed 25797505Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23.
- Background: PubMed 31800425Jules-Elysee KM, Tseng A, Sculco TP, Baaklini LR, McLawhorn AS, Pickard AJ, Qin W, Cross JR, Su EP, Fields KG, Mayman DJ. Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels. J Bone Joint Surg Am. 2019 Dec 4;101(23):2120-2128. doi: 10.2106/JBJS.19.00258.
- Individual participant dataSharing planned: No
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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.
Jean-Charles Balblanc, MD principal investigator
Hôpital Nord Franche-Comté, HNFC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular single injection and Intra-articular three injections in people with Knee Osteoarthritis, run by Labrha 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 9 inclusion and 20 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 22 Jun 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?
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?
Number of adverse event attributable to the investigational Medical Device during the week following each injection. (time frame: 1 month). 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 NCT05414617, which also lists 8 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 22 Jun 2023.