Pregnancy RelatedPRESTONCT05765539
Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal
A study testing echOpen O1 Handheld Ultrasound device in people with Pregnancy Related, run by echOpen Factory at 2 sites in Senegal.
Trial summary
Pregnancy follow-up in a country with limited resources in decentralized areas usually consists of a clinical examination exclusively because of a lack of access to additional examination equipment and qualified personnel to use them. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- echOpen O1 Handheld Ultrasound device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 2 sitesSenegal
- Study dates
- 29 Nov 2023to 19 Jun 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnancy ≥ 37 weeks of amenorrhea
- Women aged ≥ 18 years old
- Delivery scheduled to take place in the recruitment center
- Have given her written informed consent to participate
Who cannot join
- Known fetal morphological abnormality
- Emergency context during the participant's management
- Obstetrical work in progress
- Women anticipating displacement or no delivery at the clinical site
Trial locations and contacts
2 sites in 1 country.
Senegal2 sites
Poste de Santé de Karang
Karang Poste, Fatick
Centre de Santé de Sokone
Sokone, Fatick
About this study
Pregnancy follow-up in a country with limited resources in decentralized areas usually consists of a clinical examination exclusively because of a lack of access to additional examination equipment and qualified personnel to use them. However, the pregnancy follow-up relies in part on the visual investigation by ultrasound scanners that estimate the risks of morbi-mortality for the mother and child during and after pregnancy. The WHO recommendations support at least one ultrasound before 24 weeks of amenorrhea. Thus, at the same time as a usual clinical examination, the possibility of visually assessing certain relevant criteria would help to increase the effectiveness of follow-up visits without complicating the care journey. A simple ultra-portable device would be an opportunity for caregivers to facilitate the detection of complications and thus offer a more adapted follow-up and orientation.
This would allow, in contexts where resources are limited, to improve monitoring and limit the risks of complications due to inappropriate management.
Read the detailed description
The echOpen O1 Ultrasound Probe is a medical device designed to guide the diagnosis during clinical examination by providing a non-invasive, non-irradiant inside body image.
The investigator's hypothesis is that the use of this ultrasound stethoscopy probe during pregnancy, by a trained midwife, would improve the development and outcome of pregnancy for women by identifying situations requiring specificity. Through this protocol, the investigators propose a pilot study to evaluate, under field conditions, the performance of the echOpen O1 probe as part of the 3rd-trimester pregnancy monitoring, compared to a standard ultrasound examination, routinely performed with an ultrasound machine.
The main objective of this prospective pilot study is to evaluate the performance and operationality of the echOpen O1 probe from the 37th week of amenorrhea.
The secondary objectives are :
- To evaluate the feasibility and usability of the echOpen O1 probe in the context of pregnancy monitoring by midwives and in zone field conditions:
- One urban health center (Centralized)
- One rural health center (Decentralized)
- Assess women's quality of life during pregnancy and obtain satisfaction with echOpen O1 probe.
- Conditions
- Pregnancy Related
- Being tested
- echOpen O1 Handheld Ultrasound device
- Keywords
- Medical Device, Handheld Ultrasound, Echostethoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echOpen O1 Handheld Ultrasound deviceDevice
Also called Multicentric prospective comparative study
The performance of the Handheld ultrasound device (echOpen O1 device) will be assessed during these visits for all evaluation criteria.
- One examination with the US machine by the midwife focused on 4 targets ;
- One examination with a classic US machine by the same midwife (comparator) including the search for the four targets ;
- One examination with the US machine by a second operator ; Review of the images obtained by the US machine by the referring radiologist at a separate point of time.
The mode of delivery and the vital status of the mother and newborn will also be collected.
Operator A will start by using either the echOpen O1 device or the US machine (random order, via sealed envelopes) and will then perform the other type of examination.
Another operator (Operator B) will come to perform an examination with the Handheld ultrasound device (blind to the result of the first operator).
The switch between operators A and B will also be random.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women benefitting ultrasound examination | Experimental | This is the unique arm of the study. This arm is made of eligible pregnant women, with a pregnancy of at least 37 weeks. Receives: Device: echOpen O1 Handheld Ultrasound device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intra-operator agreement
The intra-operator agreement will be measured on the result of the 4 ultrasound targets chosen. The 4 ultrasound targets for each pregnancy are:
The fetal position; Number of fetuses; Fetal vitality (presence of fetal heartbeat) Placental implantation To define an intra-operator concordance, the images for the 4 ultrasound targets (collected by the same operator) must be identical for both devices (echOpen probe and Ultrasound device routinely used in pregnant women)
Measured: Day 0
Secondary outcomes (1)
The inter-operator agreement
The inter-operator concordance will be measured on the result of the 4 ultrasound targets chosen. The 4 ultrasound targets for each pregnancy are:
The fetal position; Number of fetuses; Fetal vitality (presence of fetal heartbeat) Placental implantation To define an inter-operator concordance, the images on the 4 ultrasound targets (collected by two different operators) must be identical for the same device (echOpen probe).
All ultrasound images will go to the radiologist for review and validation. This review will be done blindly of the result provided by the operators.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start29 Nov 2023
- Primary completion30 Aug 2024
- Study completion19 Jun 2025
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 Pregnancy RelatedStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group, comparative, non-randomized, controlled study. Each patient represents her/his own control: the patient is examined consecutively with the echOpen probe, then with the probe used in the department.
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- echOpen Factory
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de Dakar, Fondation Sanofi Espoir
- Responsible party
- Sponsor
- Investigators
- Fatoumata D. Sarr, M.D., MPH, Principal investigator, Institut Pasteur de Dakar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765539
- Sponsor's protocol ID
- 2023-P01
- Acronym
- PRESTO
- Status last verified
- Sep 2025
- First submitted
- 1 Mar 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edvardsson K, Mogren I, Lalos A, Persson M, Small R. A routine tool with far-reaching influence: Australian midwives' views on the use of ultrasound during pregnancy. BMC Pregnancy Childbirth. 2015 Aug 27;15:195. doi: 10.1186/s12884-015-0632-y.
PubMed 26311437Amoah B, Anto EA, Osei PK, Pieterson K, Crimi A. Boosting antenatal care attendance and number of hospital deliveries among pregnant women in rural communities: a community initiative in Ghana based on mobile phones applications and portable ultrasound scans. BMC Pregnancy Childbirth. 2016 Jun 14;16(1):141. doi: 10.1186/s12884-016-0888-x.
PubMed 27301244Edvardsson K, Ntaganira J, Ahman A, Sengoma JP, Small R, Mogren I. Physicians' experiences and views on the role of obstetric ultrasound in rural and urban Rwanda: a qualitative study. Trop Med Int Health. 2016 Jul;21(7):895-906. doi: 10.1111/tmi.12718. Epub 2016 May 18.
PubMed 27125579Holmlund S, Ntaganira J, Edvardsson K, Lan PT, Semasaka Sengoma JP, Ahman A, Small R, Mogren I. Improved maternity care if midwives learn to perform ultrasound: a qualitative study of Rwandan midwives' experiences and views of obstetric ultrasound. Glob Health Action. 2017;10(1):1350451. doi: 10.1080/16549716.2017.1350451.
PubMed 28764602Ahman A, Edvardsson K, Lesio Kidanto H, Ngarina M, Small R, Mogren I. 'Without ultrasound you can't reach the best decision' - Midwives' experiences and views of the role of ultrasound in maternity care in Dar Es Salaam, Tanzania. Sex Reprod Healthc. 2018 Mar;15:28-34. doi: 10.1016/j.srhc.2017.11.007. Epub 2017 Nov 22.
PubMed 29389498Gomes DJ, Kaufman B, Aluisio AR, Kendall S, Thomas V, Bloem C. Assessment of Acute Obstetrical Needs and the Potential Utility of Point-Of-Care Ultrasound in the North East Region of Haiti: A Cross-Sectional Study. Ann Glob Health. 2020 Jul 3;86(1):72. doi: 10.5334/aogh.2597.
PubMed 32676301Glazebrook R, Manahan D, Chater B, Barker P, Row D, Steele B, Morris G, Cornelius S, McLellan T. Educational needs of rural and remote Australian non-specialist medical practitioners for obstetric ultrasound. Aust J Rural Health. 2004 Apr;12(2):73-80. doi: 10.1111/j.1038-5282.2004.00559.x.
PubMed 15023225Swanson JO, Kawooya MG, Swanson DL, Hippe DS, Dungu-Matovu P, Nathan R. The diagnostic impact of limited, screening obstetric ultrasound when performed by midwives in rural Uganda. J Perinatol. 2014 Jul;34(7):508-12. doi: 10.1038/jp.2014.54. Epub 2014 Apr 3.
PubMed 24699218Vinayak S, Brownie S. Collaborative task-sharing to enhance the Point-Of-Care Ultrasound (POCUS) access among expectant women in Kenya: The role of midwife sonographers. J Interprof Care. 2018 Sep;32(5):641-644. doi: 10.1080/13561820.2018.1470499. Epub 2018 May 10.
PubMed 29746179Shah S, Santos N, Kisa R, Mike Maxwell O, Mulowooza J, Walker D, Muruganandan KM. Efficacy of an ultrasound training program for nurse midwives to assess high-risk conditions at labor triage in rural Uganda. PLoS One. 2020 Jun 30;15(6):e0235269. doi: 10.1371/journal.pone.0235269. eCollection 2020.
PubMed 32603339Narula J, Chandrashekhar Y, Braunwald E. Time to Add a Fifth Pillar to Bedside Physical Examination: Inspection, Palpation, Percussion, Auscultation, and Insonation. JAMA Cardiol. 2018 Apr 1;3(4):346-350. doi: 10.1001/jamacardio.2018.0001.
PubMed 29490335Van den Hof MC. No 359-Effets biologiques et innocuite de l'echographie obstetricale. J Obstet Gynaecol Can. 2018 May;40(5):633-639. doi: 10.1016/j.jogc.2018.04.008. No abstract available.
PubMed 29731209Slavin V, Gamble J, Creedy DK, Fenwick J, Pallant J. Measuring physical and mental health during pregnancy and postpartum in an Australian childbearing population - validation of the PROMIS Global Short Form. BMC Pregnancy Childbirth. 2019 Oct 22;19(1):370. doi: 10.1186/s12884-019-2546-6.
PubMed 31640626Vinayak S, Sande J, Nisenbaum H, Nolsoe CP. Training Midwives to Perform Basic Obstetric Point-of-Care Ultrasound in Rural Areas Using a Tablet Platform and Mobile Phone Transmission Technology-A WFUMB COE Project. Ultrasound Med Biol. 2017 Oct;43(10):2125-2132. doi: 10.1016/j.ultrasmedbio.2017.05.024. Epub 2017 Jul 14.
PubMed 28716434Ballard JL, Khoury JC, Wedig K, Wang L, Eilers-Walsman BL, Lipp R. New Ballard Score, expanded to include extremely premature infants. J Pediatr. 1991 Sep;119(3):417-23. doi: 10.1016/s0022-3476(05)82056-6.
PubMed 1880657
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Echopen Probe in Its Clinical Use for Pregnancy Follow-up in Senegal
- ClinicalTrials.gov ID
- NCT05765539
- Acronym / sponsor ID
- PRESTO / 2023-P01
- Conditions
- Pregnancy Related
- Keywords
- Medical Device, Handheld Ultrasound, Echostethoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- echOpen FactoryIndustry (pharma, biotech, devices)
- Collaborators
- Institut Pasteur de Dakar, Fondation Sanofi Espoir
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnancy follow-up in a country with limited resources in decentralized areas usually consists of a clinical examination exclusively because of a lack of access to additional examination equipment and qualified personnel to use them. However, the pregnancy follow-up relies in part on the visual investigation by ultrasound scanners that estimate the risks of morbi-mortality for the mother and child during and after pregnancy. The WHO recommendations support at least one ultrasound before 24 weeks of amenorrhea. Thus, at the same time as a usual clinical examination, the possibility of visually assessing certain relevant criteria would help to increase the effectiveness of follow-up visits without complicating the care journey. A simple ultra-portable device would be an opportunity for caregivers to facilitate the detection of complications and thus offer a more adapted follow-up and orientation.
This would allow, in contexts where resources are limited, to improve monitoring and limit the risks of complications due to inappropriate management.
Detailed description
The echOpen O1 Ultrasound Probe is a medical device designed to guide the diagnosis during clinical examination by providing a non-invasive, non-irradiant inside body image.
The investigator's hypothesis is that the use of this ultrasound stethoscopy probe during pregnancy, by a trained midwife, would improve the development and outcome of pregnancy for women by identifying situations requiring specificity. Through this protocol, the investigators propose a pilot study to evaluate, under field conditions, the performance of the echOpen O1 probe as part of the 3rd-trimester pregnancy monitoring, compared to a standard ultrasound examination, routinely performed with an ultrasound machine.
The main objective of this prospective pilot study is to evaluate the performance and operationality of the echOpen O1 probe from the 37th week of amenorrhea.
The secondary objectives are :
- To evaluate the feasibility and usability of the echOpen O1 probe in the context of pregnancy monitoring by midwives and in zone field conditions:
- One urban health center (Centralized)
- One rural health center (Decentralized)
- Assess women's quality of life during pregnancy and obtain satisfaction with echOpen O1 probe.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group, comparative, non-randomized, controlled study. Each patient represents her/his own control: the patient is examined consecutively with the echOpen probe, then with the probe used in the department.
| Arm | Type | Receives |
|---|---|---|
| Pregnant women benefitting ultrasound examination | Experimental | Device: echOpen O1 Handheld Ultrasound deviceThis is the unique arm of the study. This arm is made of eligible pregnant women, with a pregnancy of at least 37 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnancy ≥ 37 weeks of amenorrhea
- Women aged ≥ 18 years old
- Delivery scheduled to take place in the recruitment center
- Have given her written informed consent to participate
Key exclusion criteria (4 listed)
- Known fetal morphological abnormality
- Emergency context during the participant's management
- Obstetrical work in progress
- Women anticipating displacement or no delivery at the clinical site
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 |
|---|---|---|
| echOpen O1 Handheld Ultrasound deviceAlso: Multicentric prospective comparative studyThe performance of the Handheld ultrasound device (echOpen O1 device) will be assessed during these visits for all evaluation criteria. * One examination with the US machine by the midwife focused on 4 targets ; * One examination with a classic US machine by the same midwife (comparator) including the search for the four targets ; * One examination with the US machine by a second operator ; Review of the images obtained by the US machine by the referring radiologist at a separate point of time. The mode of delivery and the vital status of the mother and newborn will also be collected. Operator A will start by using either the echOpen O1 device or the US machine (random order, via sealed envelopes) and will then perform the other type of examination. Another operator (Operator B) will come to perform an examination with the Handheld ultrasound device (blind to the result of the first operator). The switch between operators A and B will also be random. | Device | Pregnant women benefitting ultrasound examination |
Primary outcome
The intra-operator agreement
Time frame: Day 0
The intra-operator agreement will be measured on the result of the 4 ultrasound targets chosen. The 4 ultrasound targets for each pregnancy are: The fetal position; Number of fetuses; Fetal vitality (presence of fetal heartbeat) Placental implantation To define an intra-operator concordance, the images for the 4 ultrasound targets (collected by the same operator) must be identical for both devices (echOpen probe and Ultrasound device routinely used in pregnant women)
1 secondary outcome
The inter-operator agreement
Time frame: Day 0
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 19 Sep 2025.
- Background: PubMed 26311437Edvardsson K, Mogren I, Lalos A, Persson M, Small R. A routine tool with far-reaching influence: Australian midwives' views on the use of ultrasound during pregnancy. BMC Pregnancy Childbirth. 2015 Aug 27;15:195. doi: 10.1186/s12884-015-0632-y.
- Background: PubMed 27301244Amoah B, Anto EA, Osei PK, Pieterson K, Crimi A. Boosting antenatal care attendance and number of hospital deliveries among pregnant women in rural communities: a community initiative in Ghana based on mobile phones applications and portable ultrasound scans. BMC Pregnancy Childbirth. 2016 Jun 14;16(1):141. doi: 10.1186/s12884-016-0888-x.
- Background: PubMed 27125579Edvardsson K, Ntaganira J, Ahman A, Sengoma JP, Small R, Mogren I. Physicians' experiences and views on the role of obstetric ultrasound in rural and urban Rwanda: a qualitative study. Trop Med Int Health. 2016 Jul;21(7):895-906. doi: 10.1111/tmi.12718. Epub 2016 May 18.
- Background: PubMed 28764602Holmlund S, Ntaganira J, Edvardsson K, Lan PT, Semasaka Sengoma JP, Ahman A, Small R, Mogren I. Improved maternity care if midwives learn to perform ultrasound: a qualitative study of Rwandan midwives' experiences and views of obstetric ultrasound. Glob Health Action. 2017;10(1):1350451. doi: 10.1080/16549716.2017.1350451.
- Background: PubMed 29389498Ahman A, Edvardsson K, Lesio Kidanto H, Ngarina M, Small R, Mogren I. 'Without ultrasound you can't reach the best decision' - Midwives' experiences and views of the role of ultrasound in maternity care in Dar Es Salaam, Tanzania. Sex Reprod Healthc. 2018 Mar;15:28-34. doi: 10.1016/j.srhc.2017.11.007. Epub 2017 Nov 22.
- Background: PubMed 32676301Gomes DJ, Kaufman B, Aluisio AR, Kendall S, Thomas V, Bloem C. Assessment of Acute Obstetrical Needs and the Potential Utility of Point-Of-Care Ultrasound in the North East Region of Haiti: A Cross-Sectional Study. Ann Glob Health. 2020 Jul 3;86(1):72. doi: 10.5334/aogh.2597.
- Background: PubMed 15023225Glazebrook R, Manahan D, Chater B, Barker P, Row D, Steele B, Morris G, Cornelius S, McLellan T. Educational needs of rural and remote Australian non-specialist medical practitioners for obstetric ultrasound. Aust J Rural Health. 2004 Apr;12(2):73-80. doi: 10.1111/j.1038-5282.2004.00559.x.
- Background: PubMed 24699218Swanson JO, Kawooya MG, Swanson DL, Hippe DS, Dungu-Matovu P, Nathan R. The diagnostic impact of limited, screening obstetric ultrasound when performed by midwives in rural Uganda. J Perinatol. 2014 Jul;34(7):508-12. doi: 10.1038/jp.2014.54. Epub 2014 Apr 3.
- Background: PubMed 29746179Vinayak S, Brownie S. Collaborative task-sharing to enhance the Point-Of-Care Ultrasound (POCUS) access among expectant women in Kenya: The role of midwife sonographers. J Interprof Care. 2018 Sep;32(5):641-644. doi: 10.1080/13561820.2018.1470499. Epub 2018 May 10.
- Background: PubMed 32603339Shah S, Santos N, Kisa R, Mike Maxwell O, Mulowooza J, Walker D, Muruganandan KM. Efficacy of an ultrasound training program for nurse midwives to assess high-risk conditions at labor triage in rural Uganda. PLoS One. 2020 Jun 30;15(6):e0235269. doi: 10.1371/journal.pone.0235269. eCollection 2020.
- Background: PubMed 29490335Narula J, Chandrashekhar Y, Braunwald E. Time to Add a Fifth Pillar to Bedside Physical Examination: Inspection, Palpation, Percussion, Auscultation, and Insonation. JAMA Cardiol. 2018 Apr 1;3(4):346-350. doi: 10.1001/jamacardio.2018.0001.
- Background: PubMed 29731209Van den Hof MC. No 359-Effets biologiques et innocuite de l'echographie obstetricale. J Obstet Gynaecol Can. 2018 May;40(5):633-639. doi: 10.1016/j.jogc.2018.04.008. No abstract available.
- WHO recommendations on antenatal care for a positive pregnancy experienceLink provided by the sponsor.
- 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.
Fatoumata D. Sarr, M.D., MPH principal investigator
Institut Pasteur de Dakar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing echOpen O1 Handheld Ultrasound device in people with Pregnancy Related, run by echOpen Factory at 2 sites in Senegal.
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 19 Sep 2025. 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 Senegal. 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?
The intra-operator agreement (time frame: Day 0). 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 NCT05765539, 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 19 Sep 2025.