MammographyPristina2/TRNCT04009278
Self-compression Mammography in Clinical Practice
A study testing Self compression arm in people with Mammography and Breast Cancer, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
Every year millions of mammograms are performed worldwide, representing the primary examination for the early diagnosis of breast cancer. Despite continuous advances in medicine and technology, an aspect of mammography has not changed in over fifty years: the breast is still compressed on the detector because this… Read more about this study
- Who is it for?
- Ages 18 months and older, women only
- Conditions the study is for
- Mammography, Breast Cancer
- What is being tested?
- Self compression arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jan 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women in follow-up after surgery
- Symptomatic women undergoing mammography
- Early diagnosis in asymptomatic women outside the organized screening program (these women are predominantly aged 40-44 / 75-85)
- Women with familiar risk
Who cannot join
- Augmentation prostheses
- Women in screening with active invitation
- Physical impossibility to use the self-compression command
- Inability to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-compression Mammography in Clinical Practice: A Randomized Clinical Trial Compared to Standard Compression Mammography
Every year millions of mammograms are performed worldwide, representing the primary examination for the early diagnosis of breast cancer. Despite continuous advances in medicine and technology, an aspect of mammography has not changed in over fifty years: the breast is still compressed on the detector because this allows to reduce the thickness of the breast thus improving the quality of the diagnostic image and reducing the dose of radiation necessary to obtain a clear image. Many women perceive as painful this compression, including women who have been treated for breast cancer.
Pain can discourage asymptomatic women to present themselves periodically to screening mammography, while an increasing number of women in follow-up after conservative surgery have to withstand the pain caused by mammography.
Read more
Some studies mention various factors that are responsible for pain when performing mammography: breast sensitivity, anxiety level, expected pain and staff attitude. Some studies have also identified breast density, breast volume and menstrual phase as other influencing factors, although not all studies support these hypothesis. The technical characteristics of the equipment can greatly affect annoyance, sense of oppression, pain. The technological proposals to reduce the discomfort of the patients concern various items: flexible compressors, self-compression devices under the supervision of the technician who performs the positioning and the minimum initial compression, environmental factors such as equipment noise reduction, chromatic, sound and sensory effects (eg: aromatic diffusers).
The aim of our study is to evaluate the effectiveness of the self-compression compared to the standard one, in reducing annoyance, a sense of oppression and pain, and to evaluate the difference of the average glandular dose given to the woman for each projection.
Self-compression may help reaching better compression tolerating the discomfort and pain induced thus allowing to achieve a lower thickness, a lower glandular dose and a better image.
- Conditions
- Mammography, Breast Cancer
- Being tested
- Self compression arm
- Keywords
- Pain and discomfort
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self compression armOther
The optimal compression level up will be under the supervision of the radiographer who will interpose the compression when a level is reached beyond which there is no further reduction in thickness (15 daN). If the woman stops at a compression of less than 10 daN and that the radiographer considers not adequate to perform a quality mammogram, the radiographer will perform the compression in conventional mode and record the passage of compression mode.
| Study group | Role | What they receive |
|---|---|---|
| 1. Self-compression arm | Experimental | Intervention consist in a explanation by the radiographer to the woman how to use the self-compression device, then position the woman's breasts and reach a compression of 5 daN, that this is a minimum but sub-optimal level of compression, and that at that point the woman will have to complete the compression to reach the optimal compression level up to an acceptable pain. Receives: Other: Self compression arm |
| 2. Control arm | No intervention | The mammography will be performed as normal clinical practice, with compression controlled by the radiographer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average glandular dose administered (mSv)
Average glandular dose administered during mammography is automatically computed by the machine according to an algorithm using the data on the quantity of radiation emitted and the radiation captured by the detector.
Measured: This outcome is measured at the baseline mammography.
Image quality: radiographers' scale.
Radiographers evaluate the image quality after exam with a radiographer specific 3-item scale (contrast, resolution, compression) on a 0 to 5 point scale. Higher values mean better quality.
Measured: This outcome is measured at the baseline mammography.
Image quality: radiologists' scale.
Radiologists evaluate the image quality after exam a radiologist specific 3-item scale (contrast, resolution, compression) on a 0 to 5 point scale. Higher values mean better quality.
Measured: This outcome is measured at the baseline mammography.
Secondary outcomes (8)
Breast thickness at the time of exposure (cm)
Breast thickness is measured automatically by the machine. This endpoint will be evaluated using single exposure as statistical unit, taking into account the autocorrelation of the 4 exposures in the same woman.
Measured: This outcome is measured at the baseline mammography.
Maximum compression (daN)
Compression is measured automatically by the machine. This endpoint will be evaluated using single exposure as statistical unit, taking into account the autocorrelation of the 4 exposures in the same woman.
Measured: This outcome is measured at the baseline mammography.
Pain during compression
visual assessment scale
Measured: pain will be evaluated immediately after baseline mammography execution
Memory of pain in previous mammography
visual assessment scale
Measured: before the follow up mammography, i.e. approximately 1 year after baseline mammography
Anxiety
questionnaire: State Trait Anxiety Inventory for adults - form Y (D. Spielberger).
The scale has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety.
Measured: Anxiety will be measured just before the baseline mammography and before the follow up mammography, i.e. approximately 1 year after baseline mammography.
Discomfort
Discomfort will be measured with a one-item scale with five-point range (no, slight, moderate, considerable and severe discomfort).
Measured: Discomfort will be measured just after the baseline mammography.
Execution time of the exam:
We evaluate: - total time (from randomization to close examination). Times are automatically registered by the radiology information system.
- Second breast time (from the acquisition of the second right breast projection to the acquisition of the second left breast projection)
Measured: This outcome is measured at the baseline mammography.
Participation in follow up mammography
Number of women presenting to follow up mammography (1 year +/-2 months)/number of recruited women referred to follow up mammography after 1 year
Measured: 1 year (+/- 2 months) after baseline mammography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start25 Jan 2018
- Primary completion31 Jul 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for MammographyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be proposed to women presenting for a clinical mammography . Randomization will be determined by the machine's order entry system. All women will have a mammogram performed on the Pristina. In the control arm, mammography will be performed as normal clinical practice, with compression controlled by the radiographer. In the experimental arm the radiographer will first explain to the woman how to use the self-compression device, then position the woman's breasts and reach a compression of 5 daN, that this is a minimum but sub-optimal level of compression, and that at that point the woman will have to complete the compression to reach the optimal compression level up to an acceptable pain.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Laura Canovi, RT, Principal investigator, Arcispedale S.Maria Nuova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009278
- Sponsor's protocol ID
- RCT Pristina 2/TR
- Acronym
- Pristina2/TR
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2019
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The differences in average glandular dose between the two groups will be compared with a student test if the distributions can be assimilated to a normal one and with non-parametric test in case of non-normality of the distributions. If the average glandular dose is not lower in the study group (superiority test) and / or the proportion of women with suboptimal compression (\<10daN) and\> = in the experimental group, the image quality measured with a qualitative subjective scale of the radiologist with a non-parametric test (superiority test). For secondary endpoints, the results will be compared between the two arms with student tests for the medium with normal distribution, non-parametric tests for non-normal distributions, while for the proportions a chi-square test will be performed.
Publications
Miller D, Livingstone V, Herbison P. Interventions for relieving the pain and discomfort of screening mammography. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD002942. doi: 10.1002/14651858.CD002942.pub2.
PubMed 18254010Andrews FJ. Pain during mammography: implications for breast screening programmes. Australas Radiol. 2001 May;45(2):113-7. doi: 10.1046/j.1440-1673.2001.00889.x.
PubMed 11380352Poulos A, McLean D, Rickard M, Heard R. Breast compression in mammography: how much is enough? Australas Radiol. 2003 Jun;47(2):121-6. doi: 10.1046/j.0004-8461.2003.01139.x.
PubMed 12780439Mercer CE, Hogg P, Lawson R, Diffey J, Denton ER. Practitioner compression force variability in mammography: a preliminary study. Br J Radiol. 2013 Feb;86(1022):20110596. doi: 10.1259/bjr.20110596.
PubMed 23385990Mendat CC, Mislan D, Hession-Kunz L. Patient comfort from the technologist perspective: factors to consider in mammographic imaging. Int J Womens Health. 2017 May 18;9:359-364. doi: 10.2147/IJWH.S129817. eCollection 2017.
PubMed 28572739Davey B. Pain during mammography: possible risk factors and ways to alleviate pain. Radiography. 2007;13:5
de Groot JE, Branderhorst W, Grimbergen CA, den Heeten GJ, Broeders MJM. Towards personalized compression in mammography: a comparison study between pressure- and force-standardization. Eur J Radiol. 2015 Mar;84(3):384-391. doi: 10.1016/j.ejrad.2014.12.005. Epub 2014 Dec 13.
PubMed 25554008Feder K, Grunert JH. Is Individualizing Breast Compression during Mammography useful? - Investigations of pain indications during mammography relating to compression force and surface area of the compressed breast. Rofo. 2017 Jan;189(1):39-48. doi: 10.1055/s-0042-119450. Epub 2016 Dec 21.
PubMed 28002858Guidelines for Quality Assurance in Mammography Screening, third edition, The National Cancer Screening Service Board 2008
de Groot JE, Broeders MJ, Grimbergen CA, den Heeten GJ. Pain-preventing strategies in mammography: an observational study of simultaneously recorded pain and breast mechanics throughout the entire breast compression cycle. BMC Womens Health. 2015;15:26. doi: 10.1186/s12905-015-0185-2. Epub 2015 Mar 15.
PubMed 25783657Van Goethem M, Mortelmans D, Bruyninckx E, Verslegers I, Biltjes I, Van Hove E, De Schepper A. Influence of the radiographer on the pain felt during mammography. Eur Radiol. 2003 Oct;13(10):2384-9. doi: 10.1007/s00330-002-1686-6. Epub 2002 Nov 14.
PubMed 14534806Lau S, Abdul Aziz YF, Ng KH. Mammographic compression in Asian women. PLoS One. 2017 Apr 18;12(4):e0175781. doi: 10.1371/journal.pone.0175781. eCollection 2017.
PubMed 28419125Taplin SH, Rutter CM, Finder C, Mandelson MT, Houn F, White E. Screening mammography: clinical image quality and the risk of interval breast cancer. AJR Am J Roentgenol. 2002 Apr;178(4):797-803. doi: 10.2214/ajr.178.4.1780797.
PubMed 11906848Shrestha S, Poulos A, The effect of verbal information on the experience of discomfort in mammography, Radiography, Volume 7, Issue 4, Pages 271-277; 2001
Kornguth PJ, Keefe FJ, Wright KR, Delong DM. Mammography pain in women treated conservatively for breast cancer. J Pain. 2000 Winter;1(4):268-74. doi: 10.1054/jpai.2000.7884.
PubMed 14622609
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-compression Mammography in Clinical Practice: A Randomized Clinical Trial Compared to Standard Compression Mammography
- ClinicalTrials.gov ID
- NCT04009278
- Acronym / sponsor ID
- Pristina2/TR / RCT Pristina 2/TR
- Conditions
- Mammography, Breast Cancer
- Keywords
- Pain and discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Jul 2019 (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.
Every year millions of mammograms are performed worldwide, representing the primary examination for the early diagnosis of breast cancer. Despite continuous advances in medicine and technology, an aspect of mammography has not changed in over fifty years: the breast is still compressed on the detector because this allows to reduce the thickness of the breast thus improving the quality of the diagnostic image and reducing the dose of radiation necessary to obtain a clear image. Many women perceive as painful this compression, including women who have been treated for breast cancer.
Pain can discourage asymptomatic women to present themselves periodically to screening mammography, while an increasing number of women in follow-up after conservative surgery have to withstand the pain caused by mammography.
Some studies mention various factors that are responsible for pain when performing mammography: breast sensitivity, anxiety level, expected pain and staff attitude. Some studies have also identified breast density, breast volume and menstrual phase as other influencing factors, although not all studies support these hypothesis. The technical characteristics of the equipment can greatly affect annoyance, sense of oppression, pain. The technological proposals to reduce the discomfort of the patients concern various items: flexible compressors, self-compression devices under the supervision of the technician who performs the positioning and the minimum initial compression, environmental factors such as equipment noise reduction, chromatic, sound and sensory effects (eg: aromatic diffusers).
The aim of our study is to evaluate the effectiveness of the self-compression compared to the standard one, in reducing annoyance, a sense of oppression and pain, and to evaluate the difference of the average glandular dose given to the woman for each projection.
Self-compression may help reaching better compression tolerating the discomfort and pain induced thus allowing to achieve a lower thickness, a lower glandular dose and a better image.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be proposed to women presenting for a clinical mammography . Randomization will be determined by the machine's order entry system. All women will have a mammogram performed on the Pristina. In the control arm, mammography will be performed as normal clinical practice, with compression controlled by the radiographer. In the experimental arm the radiographer will first explain to the woman how to use the self-compression device, then position the woman's breasts and reach a compression of 5 daN, that this is a minimum but sub-optimal level of compression, and that at that point the woman will have to complete the compression to reach the optimal compression level up to an acceptable pain.
| Arm | Type | Receives |
|---|---|---|
| 1. Self-compression arm | Experimental | Other: Self compression armIntervention consist in a explanation by the radiographer to the woman how to use the self-compression device, then position the woman's breasts and reach a compression of 5 daN, that this is a minimum but sub-optimal level of compression, and that at that point the woman will have to complete the compression to reach the optimal compression level up to an acceptable pain. |
| 2. Control arm | No intervention | –The mammography will be performed as normal clinical practice, with compression controlled by the radiographer. |
Who may qualify
- Ages
- 18 months and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women in follow-up after surgery
- Symptomatic women undergoing mammography
- Early diagnosis in asymptomatic women outside the organized screening program (these women are predominantly aged 40-44 / 75-85)
- Women with familiar risk
Key exclusion criteria (4 listed)
- Augmentation prostheses
- Women in screening with active invitation
- Physical impossibility to use the self-compression command
- Inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self compression armThe optimal compression level up will be under the supervision of the radiographer who will interpose the compression when a level is reached beyond which there is no further reduction in thickness (15 daN). If the woman stops at a compression of less than 10 daN and that the radiographer considers not adequate to perform a quality mammogram, the radiographer will perform the compression in conventional mode and record the passage of compression mode. | Other | 1. Self-compression arm |
Primary outcome
Average glandular dose administered (mSv)
Time frame: This outcome is measured at the baseline mammography.
Average glandular dose administered during mammography is automatically computed by the machine according to an algorithm using the data on the quantity of radiation emitted and the radiation captured by the detector.
Image quality: radiographers' scale.
Time frame: This outcome is measured at the baseline mammography.
Radiographers evaluate the image quality after exam with a radiographer specific 3-item scale (contrast, resolution, compression) on a 0 to 5 point scale. Higher values mean better quality.
Image quality: radiologists' scale.
Time frame: This outcome is measured at the baseline mammography.
Radiologists evaluate the image quality after exam a radiologist specific 3-item scale (contrast, resolution, compression) on a 0 to 5 point scale. Higher values mean better quality.
8 secondary outcomes
Breast thickness at the time of exposure (cm)
Time frame: This outcome is measured at the baseline mammography.
Maximum compression (daN)
Time frame: This outcome is measured at the baseline mammography.
Pain during compression
Time frame: pain will be evaluated immediately after baseline mammography execution
Memory of pain in previous mammography
Time frame: before the follow up mammography, i.e. approximately 1 year after baseline mammography
Anxiety
Time frame: Anxiety will be measured just before the baseline mammography and before the follow up mammography, i.e. approximately 1 year after baseline mammography.
Discomfort
Time frame: Discomfort will be measured just after the baseline mammography.
Execution time of the exam:
Time frame: This outcome is measured at the baseline mammography.
Participation in follow up mammography
Time frame: 1 year (+/- 2 months) after baseline mammography
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 12 Jun 2025.
- Results publication: PubMed 18254010Miller D, Livingstone V, Herbison P. Interventions for relieving the pain and discomfort of screening mammography. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD002942. doi: 10.1002/14651858.CD002942.pub2.
- Results publication: PubMed 11380352Andrews FJ. Pain during mammography: implications for breast screening programmes. Australas Radiol. 2001 May;45(2):113-7. doi: 10.1046/j.1440-1673.2001.00889.x.
- Results publication: PubMed 12780439Poulos A, McLean D, Rickard M, Heard R. Breast compression in mammography: how much is enough? Australas Radiol. 2003 Jun;47(2):121-6. doi: 10.1046/j.0004-8461.2003.01139.x.
- Results publication: PubMed 23385990Mercer CE, Hogg P, Lawson R, Diffey J, Denton ER. Practitioner compression force variability in mammography: a preliminary study. Br J Radiol. 2013 Feb;86(1022):20110596. doi: 10.1259/bjr.20110596.
- Results publication: PubMed 28572739Mendat CC, Mislan D, Hession-Kunz L. Patient comfort from the technologist perspective: factors to consider in mammographic imaging. Int J Womens Health. 2017 May 18;9:359-364. doi: 10.2147/IJWH.S129817. eCollection 2017.
- Results publicationDavey B. Pain during mammography: possible risk factors and ways to alleviate pain. Radiography. 2007;13:5
- Results publication: PubMed 25554008de Groot JE, Branderhorst W, Grimbergen CA, den Heeten GJ, Broeders MJM. Towards personalized compression in mammography: a comparison study between pressure- and force-standardization. Eur J Radiol. 2015 Mar;84(3):384-391. doi: 10.1016/j.ejrad.2014.12.005. Epub 2014 Dec 13.
- Results publication: PubMed 28002858Feder K, Grunert JH. Is Individualizing Breast Compression during Mammography useful? - Investigations of pain indications during mammography relating to compression force and surface area of the compressed breast. Rofo. 2017 Jan;189(1):39-48. doi: 10.1055/s-0042-119450. Epub 2016 Dec 21.
- Results publicationGuidelines for Quality Assurance in Mammography Screening, third edition, The National Cancer Screening Service Board 2008
- Results publication: PubMed 25783657de Groot JE, Broeders MJ, Grimbergen CA, den Heeten GJ. Pain-preventing strategies in mammography: an observational study of simultaneously recorded pain and breast mechanics throughout the entire breast compression cycle. BMC Womens Health. 2015;15:26. doi: 10.1186/s12905-015-0185-2. Epub 2015 Mar 15.
- Results publication: PubMed 14534806Van Goethem M, Mortelmans D, Bruyninckx E, Verslegers I, Biltjes I, Van Hove E, De Schepper A. Influence of the radiographer on the pain felt during mammography. Eur Radiol. 2003 Oct;13(10):2384-9. doi: 10.1007/s00330-002-1686-6. Epub 2002 Nov 14.
- Results publication: PubMed 28419125Lau S, Abdul Aziz YF, Ng KH. Mammographic compression in Asian women. PLoS One. 2017 Apr 18;12(4):e0175781. doi: 10.1371/journal.pone.0175781. eCollection 2017.
- Individual participant dataSharing planned: No. The differences in average glandular dose between the two groups will be compared with a student test if the distributions can be assimilated to a normal one and with non-parametric test in case of non-normality of the distributions. If the average glandular dose is not lower in the study group (superiority test) and / or the proportion of women with suboptimal compression (<10daN) and> = in the experimental group, the image quality measured with a qualitative subjective scale of the radiologist with a non-parametric test (superiority test). For secondary endpoints, the results will be compared between the two arms with student tests for the medium with normal distribution, non-parametric tests for non-normal distributions, while for the proportions a chi-square test will be performed.
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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.
Laura Canovi, RT principal investigator
Arcispedale S.Maria Nuova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self compression arm in people with Mammography and Breast Cancer, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Average glandular dose administered (mSv) (time frame: This outcome is measured at the baseline mammography.). The study lists 3 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 NCT04009278, which also lists 16 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 12 Jun 2025.