Gestational DiabetesNCT07347262
A Study Using Breath Tests to Identify Patients at Risk for Gestational Diabetes
An observational study of Gestational Diabetes, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
The aim of our study is to evaluate the feasibility, and diagnostic value of oral 13C labelled glucose breath test compared to the GCT and OGTT tests. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Noninvasive Breath Test in Order to Identify Patients at Risk for Developing Gestational Diabetes
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Dec 2020to 20 Jun 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This prospective observational pilot study will include pregnant patients with a singleton fetus up to 33 weeks gestation.
Who may be able to join
- Pregnant women
- ages 18 to 45 years old
- A singleton pregnancy
- Confirmed gestational age by a documented first-trimester ultrasound.
Who cannot join
- Patients below the age of 18 or above 45 years-old
- Patients diagnosed with gestational or pre-gestational diabetes
- Patients with multiple pregnancies or fetuses with congenital and/or chromosomal anomalies
- Patients after a multifetal pregnancy reduction (spontaneous or iatrogenic)
- Patients not having a sonographic dating during the first trimester of pregnancy
- Patients with conditions or medications that affect glucose metabolism
- Patients who will refuse to consent, or are not fit or able to read, understand, or sign an informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Use of a Novel Noninvasive Breath Test to Identify Patients at Risk for Developing Gestational Diabetes
The aim of our study is to evaluate the feasibility, and diagnostic value of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
Read the detailed description
This prospective observational pilot study will include pregnant patients with a singleton fetus up to 33 weeks gestation.
Patients meeting the inclusion criteria who are willing to participate will be asked to drink 50 or 100 grams of glucose in 200 ml water (disposable plastic cup). The test will start at approximately 08:00 with no change in normal diet is needed prior to the GCT, or after an 8-14 hour overnight fast for the OGTT.
The test will be performed at the Maternal Fetal Medicine outpatient clinics, the Maternal Fetal Medicine unit for inpatients or at the patient's residence.
Samples collection
Glucose samples:
- Venous blood samples to measure serum glucose levels will be drawn at a timing according to the performed test: for GCT at one hour after the ingestion of glucose (standard 50 grams GCT) and for OGTT at to, t1, t2 and t3 (standard 100 grams OGTT).
- Finger prick glucometer (DEX) readings will be done at one and two hours after the ingestion of glucose for participants completing GCT.
Each participant will receive a kit containing 30 12ml exetainers (Labco, UK), a compatible strew and a stamped envelope (addressed to OBGYN department, Kaplan Medical Center, Rehovot). The exetainers will be numbered sequentially and marked by the participant code (initials and participant number). After a short explanation on how to use the kit participants will be asked to sample their breath every 15 minutes starting 30 minutes before the ingestion of glucose and ending six hours after the ingestion. Patients who are taking the test at the Maternal Fetal Medicine clinic will be asked to remain at the clinic for the duration of six hours, until completing all of the samples. Patients who are taking the test while admitted to the Maternal Fetal Medicine ward and are due for discharge will not be delayed as discharge is usually until 14:00. During the six hours of participation patients will be ask to avoid food or drink. Afterwards, participants will keep the envelope in their home until a pickup is coordinated by a member of the research team.
Samples can be kept up to three months before being processed. The coded samples will next be sent to Amir Shafat's lab at Ireland for processing. Samples will be analyzed on a continuous-flow Isotope Ratio Mass Spectrometer (ABCA, Serco, UK) for breath CO2 enrichment against Vienna-Pee Dee Belemnite, a known international standard for 13C. Enrichment will be expressed in atom fraction and δV-PDB. Pilot data in Amir's lab demonstrated that this procedure gives excellent resolution of breath enrichment (to within 1 part per million) and includes peak excretion of 13CO2 in all volunteers. Percent dose recovered and other parameters indicating the rate of glucose oxidation will be calculated from the enrichment curve. Amir's laboratory has extensive experience in stable isotope and breath testing.
A few days (and no longer than one week) after the test participants will receive their GCT or OGTT result by phone and fax/email. Participants will be asked to present the test result to their physician in the next prenatal visit. For participants with a pathological GCT score, >139 mg/dL, a letter will be sent to the attending physician requesting to perform the 100 grams OGTT either as part of the study or at the health care provider clinic. Participants with one or more elevated glucose values in the OGTT, will be asked to contact their physician as soon as possible for further guidance. Two weeks after the test, a follow-up phone call will be done to all participants with a pathological result in order to ensure that the OGTT had been completed and to record the OGTT result in case of a pathological GCT, or to ensure the appropriate surveillance has begun in case of a pathological OGTT.
Demographic data including: a) maternal age; b) maternal height: c) pre-pregnancy and current weight; d) obstetrical history e) background medical illnesses and medications.
Sample size estimation In this pilot study the investigators aim to recruit 50 participants in each group (GCT and OGTT) out of which it is expected that 8-11 will have pathological result (16-21% pathological GCT).
- Conditions
- Gestational Diabetes
- Being tested
- Noninvasive Breath Test in Order to Identify Patients at Risk for Developing Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive Breath Test in Order to Identify Patients at Risk for Developing Gestational DiabetesDiagnostic test
After a short explanation on how to use the kit participants will be asked to sample their breath every 15 minutes starting 30 minutes before the ingestion of glucose and ending six hours after the ingestion.
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of our study is to evaluate the feasibility of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
We will assess feasibility via recruitment and test completion.
Measured: At the time of the glucose tolerance test (GCT/ OGTT)
To evaluate the diagnostic value of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
We will assess agreement between exogenous glucose oxidation (breath test) and blood glucose (OGTT).
Measured: At the time of the glucose tolerance test (GCT/ OGTT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start18 Dec 2020
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Galway
- Responsible party
- Principal investigator, Maya Oberman, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347262
- Sponsor's protocol ID
- 0116-19-KMC
- Status last verified
- Jan 2026
- First submitted
- 21 Sep 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
PubMed 29370047O'Sullivan JB, Mahan CM, Charles D, Dandrow RV. Screening criteria for high-risk gestational diabetic patients. Am J Obstet Gynecol. 1973 Aug 1;116(7):895-900. doi: 10.1016/s0002-9378(16)33833-9. No abstract available.
PubMed 4718216Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
PubMed 7148898Roeckner JT, Sanchez-Ramos L, Jijon-Knupp R, Kaunitz AM. Single abnormal value on 3-hour oral glucose tolerance test during pregnancy is associated with adverse maternal and neonatal outcomes: a systematic review and metaanalysis. Am J Obstet Gynecol. 2016 Sep;215(3):287-97. doi: 10.1016/j.ajog.2016.04.040. Epub 2016 Apr 29.
PubMed 27133007van Leeuwen M, Louwerse MD, Opmeer BC, Limpens J, Serlie MJ, Reitsma JB, Mol BW. Glucose challenge test for detecting gestational diabetes mellitus: a systematic review. BJOG. 2012 Mar;119(4):393-401. doi: 10.1111/j.1471-0528.2011.03254.x. Epub 2012 Jan 20.
PubMed 22260369Goldberg RJ, Ye C, Sermer M, Connelly PW, Hanley AJ, Zinman B, Retnakaran R. Predictors and clinical implications of a false negative glucose challenge test in pregnancy. J Obstet Gynaecol Can. 2013 Oct;35(10):889-898. doi: 10.1016/S1701-2163(15)30810-0.
PubMed 24165056HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
PubMed 18463375Harlass FE, Brady K, Read JA. Reproducibility of the oral glucose tolerance test in pregnancy. Am J Obstet Gynecol. 1991 Feb;164(2):564-8. doi: 10.1016/s0002-9378(11)80021-9.
PubMed 1992702Heise T, Zijlstra E, Nosek L, Heckermann S, Plum-Morschel L, Forst T. Euglycaemic glucose clamp: what it can and cannot do, and how to do it. Diabetes Obes Metab. 2016 Oct;18(10):962-72. doi: 10.1111/dom.12703. Epub 2016 Jul 13.
PubMed 27324560Huhn EA, Rossi SW, Hoesli I, Gobl CS. Controversies in Screening and Diagnostic Criteria for Gestational Diabetes in Early and Late Pregnancy. Front Endocrinol (Lausanne). 2018 Nov 27;9:696. doi: 10.3389/fendo.2018.00696. eCollection 2018.
PubMed 30538674American Diabetes Association. 2. Classification and Diagnosis of Diabetes. Diabetes Care. 2017 Jan;40(Suppl 1):S11-S24. doi: 10.2337/dc17-S005. No abstract available.
PubMed 27979889Dillon EL, Janghorbani M, Angel JA, Casperson SL, Grady JJ, Urban RJ, Volpi E, Sheffield-Moore M. Novel noninvasive breath test method for screening individuals at risk for diabetes. Diabetes Care. 2009 Mar;32(3):430-5. doi: 10.2337/dc08-1578. Epub 2008 Dec 15.
PubMed 19074994Schellekens RC, Stellaard F, Woerdenbag HJ, Frijlink HW, Kosterink JG. Applications of stable isotopes in clinical pharmacology. Br J Clin Pharmacol. 2011 Dec;72(6):879-97. doi: 10.1111/j.1365-2125.2011.04071.x.
PubMed 21801197Koletzko B, Sauerwald T, Demmelmair H. Safety of stable isotope use. Eur J Pediatr. 1997 Aug;156 Suppl 1:S12-7. doi: 10.1007/pl00014267.
PubMed 9266209Gregg CT. Some application of stable isotopes in clinical pharmacology. Eur J Clin Pharmacol. 1974 Jul 26;7(4):315-9. doi: 10.1007/BF00560350. No abstract available.
PubMed 4605121
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Use of a Novel Noninvasive Breath Test to Identify Patients at Risk for Developing Gestational Diabetes
- ClinicalTrials.gov ID
- NCT07347262
- Acronym / sponsor ID
- 0116-19-KMC
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Collaborators
- University of Galway
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 16 Jan 2026 (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 aim of our study is to evaluate the feasibility, and diagnostic value of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
Detailed description
This prospective observational pilot study will include pregnant patients with a singleton fetus up to 33 weeks gestation.
Patients meeting the inclusion criteria who are willing to participate will be asked to drink 50 or 100 grams of glucose in 200 ml water (disposable plastic cup). The test will start at approximately 08:00 with no change in normal diet is needed prior to the GCT, or after an 8-14 hour overnight fast for the OGTT.
The test will be performed at the Maternal Fetal Medicine outpatient clinics, the Maternal Fetal Medicine unit for inpatients or at the patient's residence.
Samples collection
Glucose samples:
- Venous blood samples to measure serum glucose levels will be drawn at a timing according to the performed test: for GCT at one hour after the ingestion of glucose (standard 50 grams GCT) and for OGTT at to, t1, t2 and t3 (standard 100 grams OGTT).
- Finger prick glucometer (DEX) readings will be done at one and two hours after the ingestion of glucose for participants completing GCT.
Each participant will receive a kit containing 30 12ml exetainers (Labco, UK), a compatible strew and a stamped envelope (addressed to OBGYN department, Kaplan Medical Center, Rehovot). The exetainers will be numbered sequentially and marked by the participant code (initials and participant number). After a short explanation on how to use the kit participants will be asked to sample their breath every 15 minutes starting 30 minutes before the ingestion of glucose and ending six hours after the ingestion. Patients who are taking the test at the Maternal Fetal Medicine clinic will be asked to remain at the clinic for the duration of six hours, until completing all of the samples. Patients who are taking the test while admitted to the Maternal Fetal Medicine ward and are due for discharge will not be delayed as discharge is usually until 14:00. During the six hours of participation patients will be ask to avoid food or drink. Afterwards, participants will keep the envelope in their home until a pickup is coordinated by a member of the research team.
Samples can be kept up to three months before being processed. The coded samples will next be sent to Amir Shafat's lab at Ireland for processing. Samples will be analyzed on a continuous-flow Isotope Ratio Mass Spectrometer (ABCA, Serco, UK) for breath CO2 enrichment against Vienna-Pee Dee Belemnite, a known international standard for 13C. Enrichment will be expressed in atom fraction and δV-PDB. Pilot data in Amir's lab demonstrated that this procedure gives excellent resolution of breath enrichment (to within 1 part per million) and includes peak excretion of 13CO2 in all volunteers. Percent dose recovered and other parameters indicating the rate of glucose oxidation will be calculated from the enrichment curve. Amir's laboratory has extensive experience in stable isotope and breath testing.
A few days (and no longer than one week) after the test participants will receive their GCT or OGTT result by phone and fax/email. Participants will be asked to present the test result to their physician in the next prenatal visit. For participants with a pathological GCT score, >139 mg/dL, a letter will be sent to the attending physician requesting to perform the 100 grams OGTT either as part of the study or at the health care provider clinic. Participants with one or more elevated glucose values in the OGTT, will be asked to contact their physician as soon as possible for further guidance. Two weeks after the test, a follow-up phone call will be done to all participants with a pathological result in order to ensure that the OGTT had been completed and to record the OGTT result in case of a pathological GCT, or to ensure the appropriate surveillance has begun in case of a pathological OGTT.
Demographic data including: a) maternal age; b) maternal height: c) pre-pregnancy and current weight; d) obstetrical history e) background medical illnesses and medications.
Sample size estimation In this pilot study the investigators aim to recruit 50 participants in each group (GCT and OGTT) out of which it is expected that 8-11 will have pathological result (16-21% pathological GCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This prospective observational pilot study will include pregnant patients with a singleton fetus up to 33 weeks gestation.
Key inclusion criteria (4 listed)
- Pregnant women
- ages 18 to 45 years old
- A singleton pregnancy
- Confirmed gestational age by a documented first-trimester ultrasound.
Key exclusion criteria (7 listed)
- Patients below the age of 18 or above 45 years-old
- Patients diagnosed with gestational or pre-gestational diabetes
- Patients with multiple pregnancies or fetuses with congenital and/or chromosomal anomalies
- Patients after a multifetal pregnancy reduction (spontaneous or iatrogenic)
- Patients not having a sonographic dating during the first trimester of pregnancy
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 |
|---|---|---|
| Noninvasive Breath Test in Order to Identify Patients at Risk for Developing Gestational DiabetesAfter a short explanation on how to use the kit participants will be asked to sample their breath every 15 minutes starting 30 minutes before the ingestion of glucose and ending six hours after the ingestion. | Diagnostic test | – |
Primary outcome
The aim of our study is to evaluate the feasibility of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
Time frame: At the time of the glucose tolerance test (GCT/ OGTT)
We will assess feasibility via recruitment and test completion.
To evaluate the diagnostic value of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
Time frame: At the time of the glucose tolerance test (GCT/ OGTT)
We will assess agreement between exogenous glucose oxidation (breath test) and blood glucose (OGTT).
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 16 Jan 2026.
- Background: PubMed 29370047ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
- Background: PubMed 4718216O'Sullivan JB, Mahan CM, Charles D, Dandrow RV. Screening criteria for high-risk gestational diabetic patients. Am J Obstet Gynecol. 1973 Aug 1;116(7):895-900. doi: 10.1016/s0002-9378(16)33833-9. No abstract available.
- Background: PubMed 7148898Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
- Background: PubMed 27133007Roeckner JT, Sanchez-Ramos L, Jijon-Knupp R, Kaunitz AM. Single abnormal value on 3-hour oral glucose tolerance test during pregnancy is associated with adverse maternal and neonatal outcomes: a systematic review and metaanalysis. Am J Obstet Gynecol. 2016 Sep;215(3):287-97. doi: 10.1016/j.ajog.2016.04.040. Epub 2016 Apr 29.
- Background: PubMed 22260369van Leeuwen M, Louwerse MD, Opmeer BC, Limpens J, Serlie MJ, Reitsma JB, Mol BW. Glucose challenge test for detecting gestational diabetes mellitus: a systematic review. BJOG. 2012 Mar;119(4):393-401. doi: 10.1111/j.1471-0528.2011.03254.x. Epub 2012 Jan 20.
- Background: PubMed 24165056Goldberg RJ, Ye C, Sermer M, Connelly PW, Hanley AJ, Zinman B, Retnakaran R. Predictors and clinical implications of a false negative glucose challenge test in pregnancy. J Obstet Gynaecol Can. 2013 Oct;35(10):889-898. doi: 10.1016/S1701-2163(15)30810-0.
- Background: PubMed 18463375HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Background: PubMed 1992702Harlass FE, Brady K, Read JA. Reproducibility of the oral glucose tolerance test in pregnancy. Am J Obstet Gynecol. 1991 Feb;164(2):564-8. doi: 10.1016/s0002-9378(11)80021-9.
- Background: PubMed 27324560Heise T, Zijlstra E, Nosek L, Heckermann S, Plum-Morschel L, Forst T. Euglycaemic glucose clamp: what it can and cannot do, and how to do it. Diabetes Obes Metab. 2016 Oct;18(10):962-72. doi: 10.1111/dom.12703. Epub 2016 Jul 13.
- Background: PubMed 30538674Huhn EA, Rossi SW, Hoesli I, Gobl CS. Controversies in Screening and Diagnostic Criteria for Gestational Diabetes in Early and Late Pregnancy. Front Endocrinol (Lausanne). 2018 Nov 27;9:696. doi: 10.3389/fendo.2018.00696. eCollection 2018.
- Background: PubMed 27979889American Diabetes Association. 2. Classification and Diagnosis of Diabetes. Diabetes Care. 2017 Jan;40(Suppl 1):S11-S24. doi: 10.2337/dc17-S005. No abstract available.
- Background: PubMed 19074994Dillon EL, Janghorbani M, Angel JA, Casperson SL, Grady JJ, Urban RJ, Volpi E, Sheffield-Moore M. Novel noninvasive breath test method for screening individuals at risk for diabetes. Diabetes Care. 2009 Mar;32(3):430-5. doi: 10.2337/dc08-1578. Epub 2008 Dec 15.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gestational Diabetes, run by Kaplan Medical Center at 1 site in Israel.
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 7 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 16 Jan 2026. 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 Israel. 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 aim of our study is to evaluate the feasibility of oral 13C labelled glucose breath test compared to the GCT and OGTT tests. (time frame: At the time of the glucose tolerance test (GCT/ OGTT)). 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 NCT07347262, which also lists 23 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 16 Jan 2026; AzTrials last refreshed its copy on 29 Oct 2026.