Preterm BirthSTIPPNCT05477381
Cervical Softening and the Prediction of Preterm Birth
An observational study of Preterm Birth and Threatened Preterm Labor, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Currently, transvaginal cervical length measurement is used to screen in asymptomatic pregnant women with a history of PTB. In symptomatic women, presenting with threatened PTB cervical length in combination with the fibronectin test is used to identify women at high risk to deliver preterm. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth, Threatened Preterm Labor, Premature Birth
- What is being tested?
- Measurement of cervical stiffness by Pregnolia Device
- How many people
- 390 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Aug 2022to Dec 2024
- Phase
- Observational
- 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
Study population: Women with an increased risk of preterm birth. Women are eligible when they fall in one of following categories: * Medical History of Spontaneous Preterm Birth before 34 weeks of gestation or * Threatened Preterm Birth between 24 and 34 weeks of gestation
Who may be able to join
- Age 18 years or above.
- Ability to understand Dutch or English (both spoken and written).
- Ultrasound-based gestational age determined by measurement of crown rump length (CRL) determined between 9 and 11 weeks of gestation.
- Singleton and twin pregnancies.
- Cohort A-STIPP specific:
- Medical history of spontaneous preterm birth before 34 weeks of gestation
Show all 12Show fewer
- Cohort S-STIPP specific:
- Threatened Preterm birth between 24 and 34 weeks of gestation.
- Threatened preterm birth is defined as:
- abdominal pain
- (Braxton Hicks) contractions
- vaginal blood loss.
Who cannot join
- Under 18 years of age.
- Signs of intrauterine infection.
- Obstetric indication for immediate delivery (advanced labor, cord prolapse, abruption, signs of fetal distress).
- Confirmed fetal abnormality.
- Confirmed preterm rupture of membranes.
- Confirmed vasa / placenta praevia.
- Severe vaginal bleeding and light bleeding that cannot be stopped.
- Signs of imminent labor such as blood loss, regular contractions.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ
Sofie Breuking, MD, PhD, s.h.breuking@amsterdamumc.nl
Martijn Oudijk, Prof. Dr. MD., m.a.oudijk@amsterdamumc.nl
About this study
Official title: Assessment of Cervical SofTening and the Prediction of Preterm Birth'
Currently, transvaginal cervical length measurement is used to screen in asymptomatic pregnant women with a history of PTB. In symptomatic women, presenting with threatened PTB cervical length in combination with the fibronectin test is used to identify women at high risk to deliver preterm. However, the predictive capacity of transvaginal cervical length measurement is limited. In pregnant women with a history of PTB, it only identifies a proportion of women who will have recurrent PTB. For symptomatic women, 30-60% of these women admitted to the hospital, do not deliver within seven days, leading to overtreatment of these women.
Cervical softening is precursor of cervical shortening, effacement and dilatation and therefore cervical softening is a promising new marker that is based on tissue elasticity. However, the predictive value of cervical softening and the relation with spontaneous PTB still has to be determined. With the newly developed Pregnolia® System cervical softness could be measured on a standardized and safe manner. This study could help to improve care for women with a history of spontaneous PTB.
Read the detailed description
Preterm birth (PTB) is amongst the leading causes of perinatal and childhood morbidity and mortality. Therefore, accurate identification of pregnant women at high risk of PTB is important. Identifying these women, enables obstetric healthcare professionals to apply interventions to postpone delivery and/or to prevent PTB to improve perinatal and childhood outcomes.
Currently, transvaginal cervical length measurement is used to screen asymptomatic pregnant women with a history of PTB to identify women requiring a cerclage. In symptomatic women, presenting with threatened (PTB), cervical length in combination with the fetal fibronectin(fFN) test is used to identify women at high risk to deliver within 7 days of presentation. However, the predictive capacity of transvaginal cervical length measurement is limited. In pregnant women with a history of PTB, it only identifies a proportion of women who will have recurrent PTB. For symptomatic women, 30-60% of these women admitted to the hospital, do not deliver within seven days, leading to overtreatment of these women.
Since cervical softening is a precursor of cervical shortening, effacement and dilatation, cervical softening is a promising new marker that is based on tissue elasticity. It can be measured with the CE-marked Pregnolia® System for accurate characterization of cervical softening status. It provides a value for tissue elasticity on a continuous scale.
A previous study has shown that softening of the cervix can be detected before shortening of the cervix. The Pregnolia® System may allow to detect women at risk for PTB earlier compared to traditional transvaginal ultrasound that measures shortening of the cervix, and therefore may prove useful for a more accurate risk assessment of PTB.
This current study is a single centre cohort study, where Two cohorts of women will be investigated. 1) Asymptomatic pregnant women with a history of spontaneous PTB before 34 weeks of gestation (Cohort A-STIPP). 2) Symptomatic women presenting with threatened PTB between 24 and 34 weeks (Cohort S-STIPP).
Objective: The aim of this study is to evaluate the predictive capacity of cervical softening and risk of PTB.
- Conditions
- Preterm Birth, Threatened Preterm Labor, Premature Birth, Premature Labor, Diagnosis, Cervical Incompetence, With Delivery
- Being tested
- Measurement of cervical stiffness by Pregnolia Device
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature, Disease, Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of cervical stiffness by Pregnolia DeviceDiagnostic test
The Pregnolia® System is designed to provide information about the mechanical properties of the cervical tissue by assessing the CSI (Cervical Stiffness Index) through a probe that will create a weak vacuum to retract tissue. The Pregnolia® System is designed with the purpose to provide an alternative diagnostic marker to identify women at risk of spontaneous PTB.
The Pregnolia® System is a CE-marked device developed for quantitative assessment of softening of the uterine cervix.
The Pregnolia® System will be applied within its intended use.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic women with a history of preterm birth | Pregnant women >18 years of age, with a history of spontaneous PTB before 34 weeks. All women have biweekly visits for routine transvaginal cervical length measurement between 14-24 weeks of gestation. During these visits data on cervical softening will be collected as additional marker. Receives: Diagnostic Test: Measurement of cervical stiffness by Pregnolia Device | |
| Symptomatic women with symptoms of threatened preterm birth | Pregnant women >18 years of age, between 24 and 34 weeks of gestation, presenting with symptoms of threatened Preterm birth (e.g. abdominal pain, blood loss, contractions, or other complaints suggestive for threatened Preterm birth). Receives: Diagnostic Test: Measurement of cervical stiffness by Pregnolia Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Preterm Birth < 34 weeks
Spontaneous preterm birth before 34 weeks of gestation in the asymptomatic cohort
Measured: Maximum time frame up to 28 weeks: from inclusion at 14 weeks of gestational age until delivery, with a maximum of 42 weeks of gestational age.
Delivery within seven days after inclusion
Delivery within seven days after inclusion in the symptomatic cohort
Measured: From inclusion until 7 days later
Secondary outcomes (10)
Spontaneous preterm birth <37 weeks
Spontaneous preterm birth <37 weeks of gestational age
Measured: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Spontaneous preterm birth <34 weeks
Spontaneous preterm birth <34 weeks of gestational age
Measured: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Spontaneous preterm birth <32 weeks
Spontaneous preterm birth <32 weeks of gestational age
Measured: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Spontaneous preterm birth <28 weeks
Spontaneous preterm birth <28 weeks of gestational age
Measured: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of preterm birth using cervical softening.
Development of a prediction model using cervical softening to predict the risk of preterm birth before 37, 34, 32 and 28 weeks.
Measured: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of preterm birth using the combination of cervical softening and transvaginal cervical length measurement.
Development of a prediction model using the combination of cervical softening and transvaginal cervical length measurement to predict the risk of preterm birth before 37, 34, 32 and 28 weeks.
Measured: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of preterm birth using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin.
Development of a prediction model using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin to predict the risk of preterm birth before 37, 34, 32 and 28 weeks. (only for symptomatic women)
Measured: From inclusion (symptomatic cohort 24-34 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of latency time using cervical softening.
Development of a prediction model using cervical softening to predict the latency time (interval between inclusion and delivery).
Measured: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of latency time using the combination of cervical softening and transvaginal cervical length measurement.
Development of a prediction model using the combination of cervical softening and transvaginal cervical length measurement to predict the latency time (interval between inclusion and delivery).
Measured: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age.
Prediction of latency time using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin
Development of a prediction model using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin to predict the latency time. (interval between inclusion and delivery). (only for symptomatic women)
Measured: From inclusion (symptomatic cohort 24-34 weeks) until delivery with a maximum of 42 weeks of gestational age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start18 Aug 2022
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
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 Preterm BirthStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pregnolia AG
- Responsible party
- Principal investigator, Martijn A. Oudijk, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Eva Pajkrt, Prof. Dr., Principal investigator, Amsterdam UMC, location AMCMartijn Oudijk, Prof. Dr., Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477381
- Sponsor's protocol ID
- NL80642.000.22
- Acronym
- STIPP
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All agreements regarding data sharing are defined in a signed Clinical Trial Agreement (CTA), GDPR are applicable to this agreement.
Publications
Breuking S, Oudijk MA, van Eekelen R, de Boer MA, Pajkrt E, Hermans F. Assessment of cervical softening and the prediction of preterm birth (STIPP): protocol for a prospective cohort study. BMJ Open. 2023 Nov 21;13(11):e071597. doi: 10.1136/bmjopen-2023-071597.
PubMed 37989370
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cervical SofTening and the Prediction of Preterm Birth'
- ClinicalTrials.gov ID
- NCT05477381
- Acronym / sponsor ID
- STIPP / NL80642.000.22
- Conditions
- Preterm Birth, Threatened Preterm Labor, Premature Birth, Premature Labor, Diagnosis, Cervical Incompetence, With Delivery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Pregnolia AG
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, transvaginal cervical length measurement is used to screen in asymptomatic pregnant women with a history of PTB. In symptomatic women, presenting with threatened PTB cervical length in combination with the fibronectin test is used to identify women at high risk to deliver preterm. However, the predictive capacity of transvaginal cervical length measurement is limited. In pregnant women with a history of PTB, it only identifies a proportion of women who will have recurrent PTB. For symptomatic women, 30-60% of these women admitted to the hospital, do not deliver within seven days, leading to overtreatment of these women.
Cervical softening is precursor of cervical shortening, effacement and dilatation and therefore cervical softening is a promising new marker that is based on tissue elasticity. However, the predictive value of cervical softening and the relation with spontaneous PTB still has to be determined. With the newly developed Pregnolia® System cervical softness could be measured on a standardized and safe manner. This study could help to improve care for women with a history of spontaneous PTB.
Detailed description
Preterm birth (PTB) is amongst the leading causes of perinatal and childhood morbidity and mortality. Therefore, accurate identification of pregnant women at high risk of PTB is important. Identifying these women, enables obstetric healthcare professionals to apply interventions to postpone delivery and/or to prevent PTB to improve perinatal and childhood outcomes.
Currently, transvaginal cervical length measurement is used to screen asymptomatic pregnant women with a history of PTB to identify women requiring a cerclage. In symptomatic women, presenting with threatened (PTB), cervical length in combination with the fetal fibronectin(fFN) test is used to identify women at high risk to deliver within 7 days of presentation. However, the predictive capacity of transvaginal cervical length measurement is limited. In pregnant women with a history of PTB, it only identifies a proportion of women who will have recurrent PTB. For symptomatic women, 30-60% of these women admitted to the hospital, do not deliver within seven days, leading to overtreatment of these women.
Since cervical softening is a precursor of cervical shortening, effacement and dilatation, cervical softening is a promising new marker that is based on tissue elasticity. It can be measured with the CE-marked Pregnolia® System for accurate characterization of cervical softening status. It provides a value for tissue elasticity on a continuous scale.
A previous study has shown that softening of the cervix can be detected before shortening of the cervix. The Pregnolia® System may allow to detect women at risk for PTB earlier compared to traditional transvaginal ultrasound that measures shortening of the cervix, and therefore may prove useful for a more accurate risk assessment of PTB.
This current study is a single centre cohort study, where Two cohorts of women will be investigated. 1) Asymptomatic pregnant women with a history of spontaneous PTB before 34 weeks of gestation (Cohort A-STIPP). 2) Symptomatic women presenting with threatened PTB between 24 and 34 weeks (Cohort S-STIPP).
Objective: The aim of this study is to evaluate the predictive capacity of cervical softening and risk of PTB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic women with a history of preterm birth | – | Diagnostic Test: Measurement of cervical stiffness by Pregnolia DevicePregnant women >18 years of age, with a history of spontaneous PTB before 34 weeks. All women have biweekly visits for routine transvaginal cervical length measurement between 14-24 weeks of gestation. During these visits data on cervical softening will be collected as additional marker. |
| Symptomatic women with symptoms of threatened preterm birth | – | Diagnostic Test: Measurement of cervical stiffness by Pregnolia DevicePregnant women >18 years of age, between 24 and 34 weeks of gestation, presenting with symptoms of threatened Preterm birth (e.g. abdominal pain, blood loss, contractions, or other complaints suggestive for threatened Preterm birth). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with an increased risk of preterm birth. Women are eligible when they fall in one of following categories: * Medical History of Spontaneous Preterm Birth before 34 weeks of gestation or * Threatened Preterm Birth between 24 and 34 weeks of gestation
Key inclusion criteria (12 listed)
- Age 18 years or above.
- Ability to understand Dutch or English (both spoken and written).
- Ultrasound-based gestational age determined by measurement of crown rump length (CRL) determined between 9 and 11 weeks of gestation.
- Singleton and twin pregnancies.
- Medical history of spontaneous preterm birth before 34 weeks of gestation
Key exclusion criteria (8 listed)
- Under 18 years of age.
- Signs of intrauterine infection.
- Obstetric indication for immediate delivery (advanced labor, cord prolapse, abruption, signs of fetal distress).
- Confirmed fetal abnormality.
- Confirmed preterm rupture of membranes.
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 |
|---|---|---|
| Measurement of cervical stiffness by Pregnolia DeviceThe Pregnolia® System is designed to provide information about the mechanical properties of the cervical tissue by assessing the CSI (Cervical Stiffness Index) through a probe that will create a weak vacuum to retract tissue. The Pregnolia® System is designed with the purpose to provide an alternative diagnostic marker to identify women at risk of spontaneous PTB. The Pregnolia® System is a CE-marked device developed for quantitative assessment of softening of the uterine cervix. The Pregnolia® System will be applied within its intended use. | Diagnostic test | Asymptomatic women with a history of preterm birth, Symptomatic women with symptoms of threatened preterm birth |
Primary outcome
Spontaneous Preterm Birth < 34 weeks
Time frame: Maximum time frame up to 28 weeks: from inclusion at 14 weeks of gestational age until delivery, with a maximum of 42 weeks of gestational age.
Spontaneous preterm birth before 34 weeks of gestation in the asymptomatic cohort
Delivery within seven days after inclusion
Time frame: From inclusion until 7 days later
Delivery within seven days after inclusion in the symptomatic cohort
10 secondary outcomes
Spontaneous preterm birth <37 weeks
Time frame: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Spontaneous preterm birth <34 weeks
Time frame: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Spontaneous preterm birth <32 weeks
Time frame: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Spontaneous preterm birth <28 weeks
Time frame: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of preterm birth using cervical softening.
Time frame: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of preterm birth using the combination of cervical softening and transvaginal cervical length measurement.
Time frame: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of preterm birth using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin.
Time frame: From inclusion (symptomatic cohort 24-34 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of latency time using cervical softening.
Time frame: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age
Prediction of latency time using the combination of cervical softening and transvaginal cervical length measurement.
Time frame: From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age.
Prediction of latency time using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin
Time frame: From inclusion (symptomatic cohort 24-34 weeks) until delivery with a maximum of 42 weeks of gestational age.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 37989370Breuking S, Oudijk MA, van Eekelen R, de Boer MA, Pajkrt E, Hermans F. Assessment of cervical softening and the prediction of preterm birth (STIPP): protocol for a prospective cohort study. BMJ Open. 2023 Nov 21;13(11):e071597. doi: 10.1136/bmjopen-2023-071597.
- Individual participant dataSharing planned: Yes. All agreements regarding data sharing are defined in a signed Clinical Trial Agreement (CTA), GDPR are applicable to this agreement.
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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.
Eva Pajkrt, Prof. Dr. principal investigator
Amsterdam UMC, location AMC
Martijn Oudijk, Prof. Dr. principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Threatened Preterm Labor, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 8 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofie Breuking, drs (+ 31205669111, s.h.breuking@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Preterm Birth < 34 weeks (time frame: Maximum time frame up to 28 weeks: from inclusion at 14 weeks of gestational age until delivery, with a maximum of 42 weeks of gestational age.). 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 NCT05477381, 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 5 Sep 2023.