Cystic FibrosisPhase 4HyPOINTNCT04259970
Hyperpolarized Imaging for New Treatments
A Phase 4 study testing Initiation of CFTR Modulator in people with Cystic Fibrosis, run by Children's Hospital Medical Center, Cincinnati at 4 sites in 2 countries.
Trial summary
The introduction of triple combination CFTR modulator therapy for patients with Cystic Fibrosis (CF) with at least one copy of the deltaF508 mutation is expected to provide major health benefits, but will also require novel outcome measures that can detect CF lung disease at an early stage, capture the efficacy of new… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Initiation of CFTR Modulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 13 Jan 2020to 1 May 2026
- Phase
- Phase 4
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.
- Willingness and ability to adhere to the study visit schedule and other protocol requirements.
- Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- Sweat chloride equal to or greater than 60 mEq/liter by quantitative pilocarpine iontophoresis test
- Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- Phase 1 only: Age 6 to 18 years, inclusive, at the time of consent.
Show all 13Show fewer
- Phase 2 only: Ages 9 to 18 years, inclusive, at the time of consent.
- Clinically stable with no acute antibiotic usage in the 14 days prior to the first visit.
- Genotype with F508del on at least one allele.
- No change in chronic pulmonary medications or therapies in the 28 days prior to the first visit.
- Stable CFTR modulator therapy (TEZ/IVA or LUM/IVA) for at least 28 days prior to the first visit or currently not receiving CFTR modulator therapy.
- Ability to cooperate with MRI procedures.
- Phase 1 only: FEV1 greater than or equal to 80% predicted based on GLI reference equations.
Who cannot join
- Standard MRI exclusions (Metal implants, claustrophobia).
- For females of childbearing potential: Positive urine pregnancy test at Screening or Visit 1 or Lactating.
- Any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Virginia School of Medicine
Charlottesville, Virginia, 22908
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3019
University of Wisconsin
Madison, Wisconsin, 53792
About this study
Official title: Hyperpolarized Imaging for New Treatments (HyPOINT) Study
The introduction of triple combination CFTR modulator therapy for patients with Cystic Fibrosis (CF) with at least one copy of the deltaF508 mutation is expected to provide major health benefits, but will also require novel outcome measures that can detect CF lung disease at an early stage, capture the efficacy of new therapies when disease manifestations are limited, as well as determine whether stopping existing chronic maintenance therapies does not have negative effects.
In the past decade, research has focused on the multiple breath washout (MBW) test, as a sensitive outcome measure, especially if highly-effective modulator therapies are initiated in early childhood. Even LCI, however, may not adequately capture early lung function changes, thus warranting investigation of even more sensitive outcome measures.
Read more
Magnetic resonance imaging (MRI) has the advantage of being a radiation-free modality, making it more suitable for assessing response to therapy in a shorter time frame with repeated imaging. Inhalation of a hyperpolarized gas enables the visualization and quantification of regional ventilation in the lung and can be combined with structural MRI to assess both structure and function in parallel.
The main Investigator and others have recently formed an international consortium (the 129Xe MRI Clinical Trial Consortium), comprised of both imaging experts and pulmonary clinicians to standardize imaging procedures, thus facilitating multi-site implementations. Data from this proposed study (HyPOINT; Hyperpolarized Imaging for New Treatments) will inform the future utility of MRI for both longitudinal studies to track disease progression over time as well as for future interventional trials. Further, the current study could inform the design of future trials of interventions of patients for whom currently no effective CFTR modulator therapy is available and for patients with rare genotypes thus laying the groundwork for a more personalized medicine approach in the near-term future.
Read the detailed description
The HyPOINT (HyperPOlarized Imaging for New Therapies) trial is a multicenter prospective, two phase study involving four sites with proven expertise 129Xe MRI and CF clinical care. The study sites are: University of Virginia, University of Wisconsin, and SickKids in Toronto, Canada. University of Virginia and University of Wisconsin sites will be reliant on CCHMC's IRB. SickKids in Toronto, Canada, will submit their review through their institution's Research Ethics Board (REB).
Phase 1 will include implementation of a centralized analysis program of repeated 129Xe MRI scanning in CF patients with mild lung disease to define the intra-subject variability of the primary outcome ventilation defect percentage (VDP). Patients will undergo baseline 129Xe MRI scanning and repeated measurements the same day, as well as at 28 days (± 7 days). Phase 1 will establish the intra-subject reproducibility to facilitate future use of 129Xe MRI in multi-site studies. Furthermore, the reproducibility limits defined will inform the overall design of future studies and will compare to established pulmonary function and multiple-breath washout testing (via measurement of the lung clearance index, LCI).
Safety of 129Xe MRI will be assessed by recording adverse events during the study visit (see 8.3 Adverse Events and Serious Adverse Events), which will be followed until resolved. Vital signs (heart rate, SPO2) will be recorded before, immediately following inhalation, and 2 minutes after each 129Xe inhalation; O2 saturation will be monitored continuously throughout the 129Xe portion of the MRI, and the time and duration of nadir will be recorded.
Phase 2 will be an observational study of patients assessed before and after the clinical initiation of triple-combination modulator therapy (after presumed FDA and Health Canada approval). The primary endpoint for Phase 2 is the change of VDP after 28 days of triple-combination modulator therapy. Within Phase 2, this study will also address how highly-effective modulator therapies affect lung function trajectories by measuring 129Xe MRI at 28 days (± 7 days), 6 months (± 28 days), and 12 months (± 28 days) after start of therapy (paralleling time points of the PROMISE study). Finally, to understand how 129Xe MRI can be used in combination with existing measures of lung function (e.g. spirometry, multiple breath washout), Investigators will directly compare the repeated data collected in both Phase 1 and Phase 2 to these established measures of lung function that are currently used in observational and interventional studies.
The overarching goal of this study is to define the role of structural and functional MRI imaging to facilitate future CF research studies.
- Conditions
- Cystic Fibrosis
- Being tested
- Initiation of CFTR Modulator
- Keywords
- Cystic Fibrosis, CFTR modulator therapy, 129Xe MRI, hyperpolarized xenon, LCI
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initiation of CFTR ModulatorDrug
Also called 129Xe
Inhaled contrast for MRI occurring at each 4 visits.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Phase 1 will include implementation of a centralized analysis program of repeated 129Xe MRI scanning in CF patients with mild lung disease to define the intra-subject variability of the primary outcome ventilation defect percentage (VDP). Patients will undergo baseline 129Xe MRI scanning and repeated measurements the same day, as well as at 28 days (± 7 days). Phase 1 will establish the intra-subject reproducibility to facilitate future use of 129Xe MRI in multi-site studies. Furthermore, the reproducibility limits defined will inform the overall design of future studies and will compare to established pulmonary function and multiple-breath washout testing (via measurement of the lung clearance index, LCI). Receives: Drug: Initiation of CFTR Modulator |
| Initiation of CFTR Modulator | Experimental | Phase 2 will be an observational study of patients assessed before and after the clinical initiation of triple-combination modulator therapy (after presumed FDA and Health Canada approval). The primary endpoint for Phase 2 is the change of VDP after 28 days of triple-combination modulator therapy. Within Phase 2, this study will also address how highly-effective modulator therapies affect lung function trajectories by measuring 129Xe MRI at 28 days (± 7 days), 6 months (± 28 days), and 12 months (± 28 days) after start of therapy (paralleling time points of the PROMISE study). Finally, to understand how 129Xe MRI can be used in combination with existing measures of lung function (e.g. spirometry, multiple breath washout), the investigators will directly compare the repeated data collected in both Phase 1 and Phase 2 to these established measures of lung function that are currently used in observational and interventional studies. Receives: Drug: Initiation of CFTR Modulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xe VDP Assessment
The primary analysis will use a paired, non-parametric test (e.g., Wilcoxson Rank sum) to determine if the change in VDP from baseline to 28 days is statistically different from no change in VDP.
Measured: 28 days
The change in Xe VDP after 28 days of triple modulator CFTR therapy
To understand how triple combination therapy affects lung function in the long term, we will compare the changes in VDP (summarized as the average change from baseline at 6 months and 12 months), using the same non-parametric matched analysis. This will inform the natural history of VDP and whether future studies of hyperpolarized 129Xe MRI should be designed to show an improvement in VDP or maintenance of VDP. Exploratory analyses using a mixed-effects regression model will be done to define the rate of change of VDP over the 12-month study period.
Measured: 28 days
Secondary outcomes (3)
Overall UTE MRI reader score analysis
The primary analysis will use a paired, non-parametric test (e.g., Wilcoxson Rank sum) to determine if the change in VDP from baseline to 28 days is statistically different from no change in VDP.
Measured: 28 days
The change in overall MRI reader score for UTE MRI 28 days after triple combination therapy is initiated
To understand how triple combination therapy affects lung function in the long term, we will compare the changes in VDP (summarized as the average change from baseline at 6 months and 12 months), using the same non-parametric matched analysis. This will inform the natural history of VDP and whether future studies of hyperpolarized 129Xe MRI should be designed to show an improvement in VDP or maintenance of VDP. Exploratory analyses using a mixed-effects regression model will be done to define the rate of change of VDP over the 12-month study period.
Measured: 28 days
Fev1 and LCI Correlation
A Spearman correlation will be used to determine the correlation between VDP and LCI at each study time points. A similar correlation analysis will be repeated for the change in LCI from baseline and change in VDP from baseline at each of the study time-points. With the treatment data, we will determine the concordance between the two outcomes at detecting an improvement in lung function and investigate where the two tests are discordant. A receiver operator characteristic curve will compare the diagnostic accuracy of the 129Xe MRI, and LCI. Similar analysis will be performed comparing VDP to the FEV1 and comparing the UTE MRI reader score to both LCI and FEV1. Secondary analysis will compare these changes in PFTs and LCI to changes in UTE MRI reader score and to sub-categories of regional ventilation using 129Xe MRI.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start13 Jan 2020
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, University of Wisconsin, Madison, The Hospital for Sick Children
- Responsible party
- Sponsor
- Investigators
- Jason Woods, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259970
- Sponsor's protocol ID
- 2019-1051
- Acronym
- HyPOINT
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wielputz MO, Puderbach M, Kopp-Schneider A, Stahl M, Fritzsching E, Sommerburg O, Ley S, Sumkauskaite M, Biederer J, Kauczor HU, Eichinger M, Mall MA. Magnetic resonance imaging detects changes in structure and perfusion, and response to therapy in early cystic fibrosis lung disease. Am J Respir Crit Care Med. 2014 Apr 15;189(8):956-65. doi: 10.1164/rccm.201309-1659OC.
PubMed 24564281
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized Imaging for New Treatments (HyPOINT) Study
- ClinicalTrials.gov ID
- NCT04259970
- Acronym / sponsor ID
- HyPOINT / 2019-1051
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, CFTR modulator therapy, 129Xe MRI, hyperpolarized xenon, LCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of Virginia, University of Wisconsin, Madison, The Hospital for Sick Children
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 7 Feb 2020 (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 introduction of triple combination CFTR modulator therapy for patients with Cystic Fibrosis (CF) with at least one copy of the deltaF508 mutation is expected to provide major health benefits, but will also require novel outcome measures that can detect CF lung disease at an early stage, capture the efficacy of new therapies when disease manifestations are limited, as well as determine whether stopping existing chronic maintenance therapies does not have negative effects.
In the past decade, research has focused on the multiple breath washout (MBW) test, as a sensitive outcome measure, especially if highly-effective modulator therapies are initiated in early childhood. Even LCI, however, may not adequately capture early lung function changes, thus warranting investigation of even more sensitive outcome measures.
Magnetic resonance imaging (MRI) has the advantage of being a radiation-free modality, making it more suitable for assessing response to therapy in a shorter time frame with repeated imaging. Inhalation of a hyperpolarized gas enables the visualization and quantification of regional ventilation in the lung and can be combined with structural MRI to assess both structure and function in parallel.
The main Investigator and others have recently formed an international consortium (the 129Xe MRI Clinical Trial Consortium), comprised of both imaging experts and pulmonary clinicians to standardize imaging procedures, thus facilitating multi-site implementations. Data from this proposed study (HyPOINT; Hyperpolarized Imaging for New Treatments) will inform the future utility of MRI for both longitudinal studies to track disease progression over time as well as for future interventional trials. Further, the current study could inform the design of future trials of interventions of patients for whom currently no effective CFTR modulator therapy is available and for patients with rare genotypes thus laying the groundwork for a more personalized medicine approach in the near-term future.
Detailed description
The HyPOINT (HyperPOlarized Imaging for New Therapies) trial is a multicenter prospective, two phase study involving four sites with proven expertise 129Xe MRI and CF clinical care. The study sites are: University of Virginia, University of Wisconsin, and SickKids in Toronto, Canada. University of Virginia and University of Wisconsin sites will be reliant on CCHMC's IRB. SickKids in Toronto, Canada, will submit their review through their institution's Research Ethics Board (REB).
Phase 1 will include implementation of a centralized analysis program of repeated 129Xe MRI scanning in CF patients with mild lung disease to define the intra-subject variability of the primary outcome ventilation defect percentage (VDP). Patients will undergo baseline 129Xe MRI scanning and repeated measurements the same day, as well as at 28 days (± 7 days). Phase 1 will establish the intra-subject reproducibility to facilitate future use of 129Xe MRI in multi-site studies. Furthermore, the reproducibility limits defined will inform the overall design of future studies and will compare to established pulmonary function and multiple-breath washout testing (via measurement of the lung clearance index, LCI).
Safety of 129Xe MRI will be assessed by recording adverse events during the study visit (see 8.3 Adverse Events and Serious Adverse Events), which will be followed until resolved. Vital signs (heart rate, SPO2) will be recorded before, immediately following inhalation, and 2 minutes after each 129Xe inhalation; O2 saturation will be monitored continuously throughout the 129Xe portion of the MRI, and the time and duration of nadir will be recorded.
Phase 2 will be an observational study of patients assessed before and after the clinical initiation of triple-combination modulator therapy (after presumed FDA and Health Canada approval). The primary endpoint for Phase 2 is the change of VDP after 28 days of triple-combination modulator therapy. Within Phase 2, this study will also address how highly-effective modulator therapies affect lung function trajectories by measuring 129Xe MRI at 28 days (± 7 days), 6 months (± 28 days), and 12 months (± 28 days) after start of therapy (paralleling time points of the PROMISE study). Finally, to understand how 129Xe MRI can be used in combination with existing measures of lung function (e.g. spirometry, multiple breath washout), Investigators will directly compare the repeated data collected in both Phase 1 and Phase 2 to these established measures of lung function that are currently used in observational and interventional studies.
The overarching goal of this study is to define the role of structural and functional MRI imaging to facilitate future CF research studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Drug: Initiation of CFTR ModulatorPhase 1 will include implementation of a centralized analysis program of repeated 129Xe MRI scanning in CF patients with mild lung disease to define the intra-subject variability of the primary outcome ventilation defect percentage (VDP). Patients will undergo baseline 129Xe MRI scanning and repeated measurements the same day, as well as at 28 days (± 7 days). Phase 1 will establish the intra-subject reproducibility to facilitate future use of 129Xe MRI in multi-site studies. Furthermore, the reproducibility limits defined will inform the overall design of future studies and will compare to established pulmonary function and multiple-breath washout testing (via measurement of the lung clearance index, LCI). |
| Initiation of CFTR Modulator | Experimental | Drug: Initiation of CFTR ModulatorPhase 2 will be an observational study of patients assessed before and after the clinical initiation of triple-combination modulator therapy (after presumed FDA and Health Canada approval). The primary endpoint for Phase 2 is the change of VDP after 28 days of triple-combination modulator therapy. Within Phase 2, this study will also address how highly-effective modulator therapies affect lung function trajectories by measuring 129Xe MRI at 28 days (± 7 days), 6 months (± 28 days), and 12 months (± 28 days) after start of therapy (paralleling time points of the PROMISE study). Finally, to understand how 129Xe MRI can be used in combination with existing measures of lung function (e.g. spirometry, multiple breath washout), the investigators will directly compare the repeated data collected in both Phase 1 and Phase 2 to these established measures of lung function that are currently used in observational and interventional studies. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.
- Willingness and ability to adhere to the study visit schedule and other protocol requirements.
- Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- Phase 1 only: Age 6 to 18 years, inclusive, at the time of consent.
- Phase 2 only: Ages 9 to 18 years, inclusive, at the time of consent.
Key exclusion criteria (3 listed)
- Standard MRI exclusions (Metal implants, claustrophobia).
- For females of childbearing potential: Positive urine pregnancy test at Screening or Visit 1 or Lactating.
- Any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
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 |
|---|---|---|
| Initiation of CFTR ModulatorAlso: 129XeInhaled contrast for MRI occurring at each 4 visits. | Drug | Initiation of CFTR Modulator, Phase 1 |
Primary outcome
Xe VDP Assessment
Time frame: 28 days
The primary analysis will use a paired, non-parametric test (e.g., Wilcoxson Rank sum) to determine if the change in VDP from baseline to 28 days is statistically different from no change in VDP.
The change in Xe VDP after 28 days of triple modulator CFTR therapy
Time frame: 28 days
To understand how triple combination therapy affects lung function in the long term, we will compare the changes in VDP (summarized as the average change from baseline at 6 months and 12 months), using the same non-parametric matched analysis. This will inform the natural history of VDP and whether future studies of hyperpolarized 129Xe MRI should be designed to show an improvement in VDP or maintenance of VDP. Exploratory analyses using a mixed-effects regression model will be done to define the rate of change of VDP over the 12-month study period.
3 secondary outcomes
Overall UTE MRI reader score analysis
Time frame: 28 days
The change in overall MRI reader score for UTE MRI 28 days after triple combination therapy is initiated
Time frame: 28 days
Fev1 and LCI Correlation
Time frame: 28 days
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 7 Oct 2026.
- Background: PubMed 24564281Wielputz MO, Puderbach M, Kopp-Schneider A, Stahl M, Fritzsching E, Sommerburg O, Ley S, Sumkauskaite M, Biederer J, Kauczor HU, Eichinger M, Mall MA. Magnetic resonance imaging detects changes in structure and perfusion, and response to therapy in early cystic fibrosis lung disease. Am J Respir Crit Care Med. 2014 Apr 15;189(8):956-65. doi: 10.1164/rccm.201309-1659OC.
- 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.
Jason Woods, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Initiation of CFTR Modulator in people with Cystic Fibrosis, run by Children's Hospital Medical Center, Cincinnati at 4 sites in 2 countries.
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 13 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Xe VDP Assessment (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT04259970, 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 7 Oct 2026.