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Emphysema or COPDBREATHE-1NCT05854550

First in Human Study to Assess an Implant to Treat Severe Emphysema

A study testing Apreo Implant Group in people with Emphysema or COPD, run by Apreo Health, Inc. at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants. The main questions it aims to answer are: Is it safe? Does it work? Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed… Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Emphysema or COPD
What is being tested?
Apreo Implant Group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesAustralia
Study dates
5 May 2023to 16 Feb 2026
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 35 and ≤ 80 years old
  • Computed tomography (CT) scan evidence of homogeneous or heterogeneous emphysema
  • At least one target lobe with > 35% destruction (percent of voxels with < -950 Hounsfield units on CT)
  • Post-bronchodilator ratio of FEV1/FVC < 0.7 at screening
  • Post-bronchodilator FEV1 percent predicted ≥20% and ≤50% of predicted at screening
  • Post-bronchodilator RV > 180% predicted
Show all 12Show fewer
  • Post-bronchodilator RV/TLC ≥ 0.55 at screening
  • Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4
  • Cotinine testing at screening indicates nonsmoker and stopped smoking at least 8 weeks before entering the trial and agrees to refrain from smoking for duration of study participation
  • Participation in a pulmonary rehabilitation program and/or confirmed to have been engaged or attempted regular physical activity in the 12 months prior to the first Apreo Procedure and agrees to continue or restart regular physical activity for the duration of the study
  • Fully vaccinated for Covid-19 (up to date per Australian Government Guidelines) and has current pneumococcus and influenza vaccination (or documented clinical intolerance)
  • Cognitively and physically able to provide written informed consent and complete participant questionnaires

Who cannot join

  • Arterial blood PaCO2 > 60 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa)
  • DLCO <20% at screening
  • Steroid therapy of 10 mg prednisolone (prednisone) or more per day
  • Three or more acute exacerbations of COPD in the past year before enrollment
  • Two or more hospitalizations for acute exacerbations of COPD or respiratory infections in the past year before enrollment
  • Any acute exacerbation of COPD or respiratory infection less than 4 weeks before the first Apreo Procedure
Show all 31Show fewer
  • Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant
  • Known history of pulmonary arterial hypertension
  • Presence of a giant bulla (≥ 30% of hemithorax)
  • History of excessive dynamic airway collapse of the trachea or main bronchi
  • History of adult asthma or chronic bronchitis
  • Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up, diagnostics or treatment
  • Unequivocal and symptomatic bronchiectasis
  • Unequivocal lung cancer or other current cancer diagnosis except non-metastasized basal cell skin cancer
  • Uncontrolled hypertension (blood pressure that is inadequately treated or resistant to treatment) with a systolic > 200 mmHg or diastolic > 110 mmHg at screening or prior to first Apreo Procedure
  • Uncorrectable coagulopathy or other condition likely to increase risk of peri- or post- Apreo Procedure bleeding
  • On anticoagulant or antiplatelet therapy and unable or unwilling to hold for Apreo Procedure
  • Coronary artery disease with angina
  • History of myocardial infarction within 6 months
  • History of a stroke less than 1 year before the first Apreo Procedure
  • Clinical history of heart failure with documented LVEF ≤ 40%
  • Clinical history of diabetes with a HbA1c > 9.0%
  • Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 (CKD-EPI) OR participant with kidney failure (Stage 5 kidney disease)
  • Mechanical ventilator dependence except participants using nocturnal bi-level positive airway pressure (biPAP) or continuous positive airway pressure (CPAP) are allowed if it would not preclude safe implantation of the study device
  • Pregnant, lactating, or women of childbearing potential who plan to become pregnant within the study duration
  • Known hypersensitivity to nitinol
  • Significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis
  • Any disease or condition likely to limit survival to less than one year
  • Concomitant illnesses or medications that may pose a significant increased risk for complications following an Apreo Procedure
  • Currently enrolled in another trial and actively receiving experimental treatment
  • Any condition in the opinion of the investigator that would interfere with safe and complete collection of study data including the safe conduction of bronchoscopy procedures

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • Macquarie University Hospital

    Macquarie, New South Wales, 2109

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

About this study

Official title: Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung

The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants. The main questions it aims to answer are:

Is it safe? Does it work?

Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).

Read the detailed description

This is a first-in-human, prospective, multi-center, single-arm study assessing the safety, feasibility and preliminary efficacy of the Apreo Implant for severe emphysema in up to 30 participants. Initially all participants will undergo an Apreo Procedure involving placement of up to three implants in a native bronchial tree of one lung followed by a second Apreo Procedure 30 days later to place up to three implants in the contralateral native lung bronchial tree if indicated.

Once the fifth participant has undergone his or her first implantation procedure, implantations in currently enrolled or new participants will be paused to allow for a Safety Review Committee (SRC) to convene and review safety data once the 5th participant has completed the 7-day phone follow-up after their second Apreo Procedure (or first if only one procedure). This would be at a minimum acute procedural safety for up to 10 implantation procedures conducted in these first 5 participants, 30-day safety assessments for all 5 participants after their first lung implantations, bronchoscopic inspection 30 days after implantation of all implants in the first lung, and 7-day safety data after their first and second lung implantations. The SRC will provide comments and recommendations, including the restart of implantation for new participants, if deemed appropriate.

After the first 10 participants have completed the 7-day phone follow-up after the second Apreo Procedure (or first if only one procedure), their safety data will be reviewed by the SRC. This would include at a minimum acute procedural safety for up to 20 implantation procedures conducted in these first 10 participants, 30-day safety assessments for all 10 participants after their first lung implantations, bronchoscopic inspection 30 days after implantation of all implants in the first lung, and 7-day safety data after their first and second lung implantations. Following the review of the first 10 participants' safety data, the SRC may allow any subsequently enrolled participants to undergo one Apreo Procedure (rather than two separate procedures if appropriate for a participant) to deploy Apreo Implants in both the left and right lung airways as indicated or to continue to have all participants undergo two separate Apreo Procedures if indicated. A total of up to 30 participants will be enrolled overall.

All participants will be followed at 30 days, three, six and twelve months post the first Apreo Procedure.

Being tested
Apreo Implant Group
Keywords
hyperinflation, air-trapping, emphysema, COPD
Medical subject headings
Emphysema, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apreo Implant GroupDevice

    One or two procedures involving placement of up to three Apreo implants in the bronchial tree of each lung.

Study groups in NCT05854550
Study groupRoleWhat they receive
Apreo Implant GroupExperimentalThis group will undergo up to 2 procedures and will receive up to 3 implants during in each lung.
Receives: Device: Apreo Implant Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Serious Adverse Events (SAE) at 6 Months

    Rate of occurrence of serious adverse events related to the study device and/or study procedure through 6 months post-study procedure

    Measured: 6 Months

Secondary outcomes (71)

  1. Device Evaluation: Device Deployment Assessment

    Evaluation of the ability to deploy the Apreo Implant in target airways (There is no scale - questions are assessed individually)

    Measured: During Procedure

  2. Device Evaluation: Device Usability Survey

    Evaluate operator device use challenges (There is no scale - questions are assessed individually)

    Measured: During Procedure

  3. Device Evaluation: Instructions for Use (IFU) Survey

    Evaluate operator understanding of instructions for use (There is no scale - questions are assessed individually)

    Measured: During Procedure

  4. Efficacy Evaluation: Airway Patency at 30 Days

    Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)

    Measured: 30 Days

  5. Efficacy Evaluation: Airway Patency at 3 Months

    Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)

    Measured: 3 Months

  6. Efficacy Evaluation: Airway Patency at 6 Months

    Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)

    Measured: 6 Months

  7. Efficacy Evaluation: Airway Patency at 12 Months

    Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)

    Measured: 12 Months

  8. Efficacy Evaluation: Mucus Assessment at 30 Days

    Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)

    Measured: 30 Days

  9. Efficacy Evaluation: Mucus Assessment at 3 Months

    Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)

    Measured: 3 Months

  10. Efficacy Evaluation: Mucus Assessment at 6 Months

    Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)

    Measured: 6 Months

  11. Efficacy Evaluation: Mucus Assessment at 12 Months

    Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)

    Measured: 12 Months

  12. Efficacy Evaluation: Computed Tomography (CT) Scan at 6 Months

    CT evaluation of Apreo Implant diameter

    Measured: 6 Months

  13. Efficacy Evaluation: CT Scan at 12 Months

    CT evaluation of Apreo Implant diameter

    Measured: 12 Months

  14. Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 1-3 Days

    Change in FEV1 between Baseline and 1-3 days post-procedure

    Measured: 1-3 Days

  15. Efficacy Evaluation: FEV1 at 30 Days

    Change in FEV1 between Baseline and 30 days post-procedure

    Measured: 30 Days

  16. Efficacy Evaluation: FEV1 at 3 Months

    Change in FEV1 between Baseline and 3 months post-procedure

    Measured: 3 Months

  17. Efficacy Evaluation: FEV1 at 6 Months

    Change in FEV1 between Baseline and 6 months post-procedure

    Measured: 6 Months

  18. Efficacy Evaluation: FEV1 at 12 Months

    Change in FEV1 between Baseline and 12 months post-procedure

    Measured: 12 Months

  19. Efficacy Evaluation: Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) at 6 Months

    Change in DLCO between baseline and 6 months post-procedure

    Measured: 6 Months

  20. Efficacy Evaluation: Residual Volume (RV) at 6 Months

    Change in RV between baseline and 6 months as assessed by quantitative CT

    Measured: 6 Months

  21. Efficacy Evaluation: Residual Volume (RV) at 12 Months

    Change in RV between baseline and 12 months as assessed by quantitative CT

    Measured: 12 Months

  22. Efficacy Evaluation: Arterial Blood Gas (ABG): PaO2 at 6 Months

    Change in PaO2 between baseline and 6 months

    Measured: 6 Months

  23. Efficacy Evaluation: Arterial Blood Gas (ABG): PaCO2 at 6 Months

    Change in PaCO2 between baseline and 6 months

    Measured: 6 Months

  24. Safety: Procedural Complications

    Percentage of participants with acute procedural complications within 24 hours of study procedure

    Measured: Through 24 hours post-procedure

  25. Safety: Rate of SAEs

    Rate of occurrence of serious adverse events related to the device and/or Apreo procedure through 12 months

    Measured: Through 12 Months

  26. Safety: Rate of Adverse Device Effects

    Rate of adverse device effects through 12 months post-procedure

    Measured: Through 12 Months

  27. Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 1-3 Days

    Change in FEV1/FVC between Baseline and 1-3 days post-procedure

    Measured: 1-3 Days

  28. Efficacy Evaluation: FEV1/FVC at 30 Days

    Change in FEV1/FVC between Baseline and 30 days post-procedure

    Measured: 30 Days

  29. Efficacy Evaluation: FEV1/FVC at 3 Months

    Change in FEV1/FVC between Baseline and 3 Months post-procedure

    Measured: 3 Months

  30. Efficacy Evaluation: FEV1/FVC at 6 Months

    Change in FEV1/FVC between Baseline and 6 Months post-procedure

    Measured: 6 Months

  31. Efficacy Evaluation: FEV1/FVC at 12 Months

    Change in FEV1/FVC between Baseline and 12 Months post-procedure

    Measured: 12 Months

  32. Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 1-3 Days

    Change in RV between Baseline and 1-3 Days

    Measured: 1-3 Days

  33. Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 30 Days

    Change in RV between Baseline and 30 Days

    Measured: 30 Days

  34. Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 3 Months

    Change in RV between Baseline and 3 Months

    Measured: 3 Months

  35. Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 6 Months

    Change in RV between Baseline and 6 Months

    Measured: 6 Months

  36. Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 12 Months

    Change in RV between Baseline and 12 Months

    Measured: 12 Months

  37. Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 1-3 Days

    Change in RV/TLC between Baseline and 1-3 Days

    Measured: 1-3 Days

  38. Efficacy Evaluation: RV/TLC at 30 Days

    Change in RV/TLC between Baseline and 30 Days

    Measured: 30 Days

  39. Efficacy Evaluation: RV/TLC at 3 Months

    Change in RV/TLC between Baseline and 3 Months

    Measured: 3 Months

  40. Efficacy Evaluation: RV/TLC at 6 Months

    Change in RV/TLC between Baseline and 6 Months

    Measured: 6 Months

  41. Efficacy Evaluation: RV/TLC at 12 Months

    Change in RV/TLC between Baseline and 12 Months

    Measured: 12 Months

  42. Efficacy Evaluation: Forced Vital Capacity (FVC) at 1-3 Days

    Change in FVC between Baseline and 1-3 Days

    Measured: 1-3 Days

  43. Efficacy Evaluation: FVC at 30 Days

    Change in FVC between Baseline and 30 Days

    Measured: 30 Days

  44. Efficacy Evaluation: FVC at 3 Months

    Change in FVC between Baseline and 3 Months

    Measured: 3 Months

  45. Efficacy Evaluation: FVC at 6 Months

    Change in FVC between Baseline and 6 Months

    Measured: 6 Months

  46. Efficacy Evaluation: FVC at 12 Months

    Change in FVC between Baseline and 12 Months

    Measured: 12 Months

  47. Efficacy Evaluation: Six Minute Walk Test (6MWT) at 1-3 Days

    Change in 6MWT between Baseline and 1-3 Days

    Measured: 1-3 Days

  48. Efficacy Evaluation: Six Minute Walk Test (6MWT) at 30 Days

    Change in 6MWT between Baseline and 30 Days

    Measured: 30 Days

  49. Efficacy Evaluation: Six Minute Walk Test (6MWT) at 3 Months

    Change in 6MWT between Baseline and 3 Months

    Measured: 3 Months

  50. Efficacy Evaluation: Six Minute Walk Test (6MWT) at 6 Months

    Change in 6MWT between Baseline and 6 Months

    Measured: 6 Months

  51. Efficacy Evaluation: Six Minute Walk Test (6MWT) at 12 Months

    Change in 6MWT between Baseline and 12 Months

    Measured: 12 Months

  52. Efficacy Evaluation: Modified Borg Dyspnoea Scale at 1-3 Days

    Change in Modified BORG Dyspnea Scale between Baseline and 1-3 Days (scale is 0= no difficulty breathing to 10=maximal difficulty)

    Measured: 1-3 Days

  53. Efficacy Evaluation: Modified Borg Dyspnoea Scale at 30 Days

    Change in Modified BORG Dyspnea Scale between Baseline and 30 Days (scale is 0= no difficulty breathing to 10=maximal difficulty)

    Measured: 30 Days

  54. Efficacy Evaluation: Modified Borg Dyspnoea Scale at 3 Months

    Change in Modified BORG Dyspnea Scale between Baseline and 3 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)

    Measured: 3 Months

  55. Efficacy Evaluation: Modified Borg Dyspnoea Scale at 6 Months

    Change in Modified BORG Dyspnea Scale between Baseline and 6 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)

    Measured: 6 Months

  56. Efficacy Evaluation: Modified Borg Dyspnoea Scale at 12 Months

    Change in Modified BORG Dyspnea Scale between Baseline and 12 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)

    Measured: 12 Months

  57. Efficacy Evaluation: COPD Assessment Test (CAT) at 1-3 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)

    Change in CAT between Baseline and 1-3 Days

    Measured: 1-3 Days

  58. Efficacy Evaluation: COPD Assessment Test (CAT) at 30 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)

    Change in CAT between Baseline and 30 Days

    Measured: 30 Days

  59. Efficacy Evaluation: Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at 3 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)

    Change in CAT between Baseline and 3 Months

    Measured: 3 Months

  60. Efficacy Evaluation: COPD Assessment Test (CAT) at 6 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)

    Change in CAT between Baseline and 6 Months

    Measured: 6 Months

  61. Efficacy Evaluation: COPD Assessment Test (CAT) at 12 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)

    Change in CAT between Baseline and 12 Months

    Measured: 12 Months

  62. Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 1-3 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)

    Change in SGRQ-C between Baseline and 1-3 Days

    Measured: 1-3 Days

  63. Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 30 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)

    Change in SGRQ-C between Baseline and 30 Days

    Measured: 30 Days

  64. Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 3 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)

    Change in SGRQ-C between Baseline and 3 Months

    Measured: 3 Months

  65. Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 6 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)

    Change in SGRQ-C between Baseline and 6 Months

    Measured: 6 Months

  66. Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 12 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)

    Change in SGRQ-C between Baseline and 12 Months

    Measured: 12 Months

  67. Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 1-3 Days

    Change in mMRC between Baseline and 1-3 Days

    Measured: 1-3 Days

  68. Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 30 Days

    Change in mMRC between Baseline and 30 Days

    Measured: 30 Days

  69. Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 3 Months

    Change in mMRC between Baseline and 3 Months

    Measured: 3 Months

  70. Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 6 Months

    Change in mMRC between Baseline and 6 Months

    Measured: 6 Months

  71. Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 12 Months

    Change in mMRC between Baseline and 12 Months

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start5 May 2023
  3. Primary completion8 Oct 2024
  4. Study completion16 Feb 2026

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05854550
Sponsor's protocol ID
CIP-0001
Acronym
BREATHE-1
Status last verified
Jan 2025
First submitted
20 Apr 2023
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tana A, Valipour A, Ing A, Steinfort DP, Orton CM, Klooster K, Klemm T, Williamson JP, Christie JJ, Garner JL, Koster TD, Welz K, van Dijk M, Mayse ML, Shah PL, Slebos DJ; BREATHE Study Group. Airway Scaffolds for Emphysema-related Hyperinflation: Six-Month Results from the BREATHE Trial. Am J Respir Crit Care Med. 2025 Jul;211(7):1175-1184. doi: 10.1164/rccm.202502-0378OC.

    PubMed 40387356

Questions about this trial

What is this clinical trial studying?

A study testing Apreo Implant Group in people with Emphysema or COPD, run by Apreo Health, Inc. at 2 sites in Australia.

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 12 inclusion and 31 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 31 Mar 2026. 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 Australia. 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?

Rate of Serious Adverse Events (SAE) at 6 Months (time frame: 6 Months). 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 NCT05854550, which also lists 1 linked publication.

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 31 Mar 2026.

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