Abdominal Aortic AneurysmNCT05346289
Elective Treatment Rates and Surgical Non-eligibility Among Men and Women With Intact Abdominal Aortic Aneurysms
An observational study of Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm Without Rupture, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The overall aim is to determine the frequency by which women and men with intact abdominal aortic aneurysms (AAA) are treated with elective surgery at three vascular outpatient clinics in Europe, and to investigate whether the reasons to refrain from elective surgery differ between the sexes. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm Without Rupture, Aneurysm
- What is being tested?
- Elective surgery for intact AAA
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2020to 1 Nov 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All men and women diagnosed with an intact abdominal aortic aneurysm (ICD10 classification I71.4) and who fulfill the inclusion diameter criterion and none of the exclusion criteria are consecutively included from January 2014 and onwards at three vascular outpatient departments in Europe (Karolinska University Hospital, Stockholm, Sweden; St. Olav Hospital, Trondheim, Norway; Medical University of Graz, Graz, Austria) until reaching prespecified study target size according to power calculation (200 women, 200 men).
Who may be able to join
- Intact abdominal aortic aneurysm 30 mm or larger in men and women irrespective of underlying pathogenesis (atherosclerotic, mycotic, previous dissection).
Who cannot join
- Previous aortic surgery or surgical treatment for AAA
- Ruptured AAA at index contact
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elective Treatment Rates Among Patients With Intact Abdominal Aortic Aneurysms -Patient- and Aneurysm-related Factors as Determinants of Surgical Non-eligibility in Women and Men
The overall aim is to determine the frequency by which women and men with intact abdominal aortic aneurysms (AAA) are treated with elective surgery at three vascular outpatient clinics in Europe, and to investigate whether the reasons to refrain from elective surgery differ between the sexes.
Read the detailed description
Abdominal aortic aneurysm (AAA) is a local widening of the infrarenal aorta (1). The natural history of AAA is progressive and may lead to rupture, a true surgical emergency with a mortality rate of 100% without immediate treatment. Men are more commonly affected (2, 3), however, women demonstrate a notably elevated risk of rupture (4, 5) and constitute up to 1/3 of all ruptures (4, 5). One plausible explanation could be a sex discrepancy in elective treatment rates.
There is both national and international evidence implying that AAA treatments, both elective and emergent, are withheld among women (6-14). Studies on elective treatment rates are especially scarce, as the vast majority of databases and vascular registries only include data on treated AAA patients. A few single-center studies from the UK (6, 7, 15) and one meta-analysis (8) have recorded lower treatment rates among women. We have recently analyzed the issue of elective treatment rates in our group using a population-based approach (manuscript submitted). Of all patients diagnosed with an intact AAA in Sweden during 2001-2015 (n=32 393, 21% women), a crude proportion as high as 60 % did not proceed to receive surgical treatment. The proportion of untreated women (67 %) surpassed that of men (59 %). In the multivariate analyses, female sex and advanced age emerged as the strongest predictors for remaining untreated despite other characteristics such as comorbidities, civil status and individual disposable household income. The median time from diagnosis to treatment for those treated was surprisingly short at 1.6 years.
The foremost intention-to-treat variable that determines the indication for elective surgery is the maximal diameter of the aneurysm (55 mm in men, 50 mm in women; (16, 17)). Population-based investigations, while comprehensive, fall short in terms of aneurysm-specific data. Therefore, these analyses assume comparable diameter distributions and similar morphology for men and women. Similarly, longitudinal follow-up data from the clinical setting, such as records of patient's wishes and physiological preoperative examinations, cannot be extracted for the purpose of nationwide analyses. Thus, the question remains whether the observed gender gap in elective treatment rates persists after detailed considerations of patient- and aneurysm-specific characteristics. A discrepancy in elective treatment rates could also lead to different long-term outcomes, with higher rupture and mortality rates among women.
- Conditions
- Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm Without Rupture, Aneurysm, Aortic Aneurysm, Aneurysm Abdominal
- Being tested
- Elective surgery for intact AAA
- Keywords
- Sex differences, Elective treatment rate, Surgical eligibility, Surgical treatment, Conservative treatment, Untreated
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective surgery for intact AAAProcedure or surgery
Elective surgery including the following modalities: open repair, endovascular repair (EVAR), fenestrated end-vascular repair (FEVAR).
| Study group | Role | What they receive |
|---|---|---|
| Women | Not described Receives: Procedure: Elective surgery for intact AAA | |
| Men | Not described Receives: Procedure: Elective surgery for intact AAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Elective Treatment Status
Relative frequency of women and men that were electively treated or left untreated, the latter group subcategorized into patients who did or did not reach the diameter threshold for surgical treatment (50 mm women, 55 men).
Measured: End of follow-up in December 2021 with maximal possible follow-up of seven years.
Sex-Specific Reasons for Remaining Untreated
Frequency distribution of underlying reasons behind non-treatment among those men and women who reached the treatment threshold. Primary reason registered as patient- (comorbidity, patient's wish) or AAA-related (morphology).
Measured: Evaluated at the time of the conservative treatment decision during maximal follow-up of seven years.
Secondary outcomes (2)
Rupture Rate
Sex-specific rates of rupture in each treatment arm during follow-up.
Measured: Study end December 2021.
Mortality Rate
Sex-specific rates of mortality in each treatment arm during follow-up.
Measured: Study end December 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Jun 2020
- Primary completion14 Feb 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, St. Olavs Hospital
- Responsible party
- Principal investigator, Rebecka Hultgren, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346289
- Sponsor's protocol ID
- ESPN201689310422
- Status last verified
- Nov 2022
- First submitted
- 20 Apr 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sakalihasan N, Michel JB, Katsargyris A, Kuivaniemi H, Defraigne JO, Nchimi A, Powell JT, Yoshimura K, Hultgren R. Abdominal aortic aneurysms. Nat Rev Dis Primers. 2018 Oct 18;4(1):34. doi: 10.1038/s41572-018-0030-7.
PubMed 30337540Lederle FA, Johnson GR, Wilson SE; Aneurysm Detection and Management Veterans Affairs Cooperative Study. Abdominal aortic aneurysm in women. J Vasc Surg. 2001 Jul;34(1):122-6. doi: 10.1067/mva.2001.115275.
PubMed 11436084Scott RA, Bridgewater SG, Ashton HA. Randomized clinical trial of screening for abdominal aortic aneurysm in women. Br J Surg. 2002 Mar;89(3):283-5. doi: 10.1046/j.0007-1323.2001.02014.x.
PubMed 11872050Sweeting MJ, Thompson SG, Brown LC, Powell JT; RESCAN collaborators. Meta-analysis of individual patient data to examine factors affecting growth and rupture of small abdominal aortic aneurysms. Br J Surg. 2012 May;99(5):655-65. doi: 10.1002/bjs.8707. Epub 2012 Mar 5.
PubMed 22389113Brown LC, Powell JT. Risk factors for aneurysm rupture in patients kept under ultrasound surveillance. UK Small Aneurysm Trial Participants. Ann Surg. 1999 Sep;230(3):289-96; discussion 296-7. doi: 10.1097/00000658-199909000-00002.
PubMed 10493476Karthikesalingam A, Nicoli TK, Holt PJ, Hinchliffe RJ, Pasha N, Loftus IM, Thompson MM. The fate of patients referred to a specialist vascular unit with large infra-renal abdominal aortic aneurysms over a two-year period. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):295-301. doi: 10.1016/j.ejvs.2011.04.022. Epub 2011 May 14.
PubMed 21576025Whittaker JD, Meecham L, Summerour V, Khalil S, Layton G, Yousif M, Jennings A, Wall M, Newman J. Outcome after Turndown for Elective Abdominal Aortic Aneurysm Surgery. Eur J Vasc Endovasc Surg. 2017 Nov;54(5):579-586. doi: 10.1016/j.ejvs.2017.07.023. Epub 2017 Sep 2.
PubMed 28874329Sweeting MJ, Masconi KL, Jones E, Ulug P, Glover MJ, Michaels JA, Bown MJ, Powell JT, Thompson SG. Analysis of clinical benefit, harms, and cost-effectiveness of screening women for abdominal aortic aneurysm. Lancet. 2018 Aug 11;392(10146):487-495. doi: 10.1016/S0140-6736(18)31222-4. Epub 2018 Jul 26.
PubMed 30057105Zommorodi S, Bottai M, Hultgren R. Sex differences in repair rates and outcomes of patients with ruptured abdominal aortic aneurysm. Br J Surg. 2019 Oct;106(11):1480-1487. doi: 10.1002/bjs.11258. Epub 2019 Aug 12.
PubMed 31403186Aber A, Tong TS, Chilcott J, Thokala P, Maheswaran R, Thomas SM, Nawaz S, Walters S, Michaels J. Sex differences in national rates of repair of emergency abdominal aortic aneurysm. Br J Surg. 2019 Jan;106(1):82-89. doi: 10.1002/bjs.11006. Epub 2018 Nov 5.
PubMed 30395361Kuhnl A, Erk A, Trenner M, Salvermoser M, Schmid V, Eckstein HH. Incidence, Treatment and Mortality in Patients with Abdominal Aortic Aneurysms. Dtsch Arztebl Int. 2017 Jun 5;114(22-23):391-398. doi: 10.3238/arztebl.2017.0391.
PubMed 28655374McPhee JT, Hill JS, Eslami MH. The impact of gender on presentation, therapy, and mortality of abdominal aortic aneurysm in the United States, 2001-2004. J Vasc Surg. 2007 May;45(5):891-9. doi: 10.1016/j.jvs.2007.01.043. Epub 2007 Mar 28.
PubMed 17391899Dueck AD, Johnston KW, Alter D, Laupacis A, Kucey DS. Predictors of repair and effect of gender on treatment of ruptured abdominal aortic aneurysm. J Vasc Surg. 2004 Apr;39(4):784-7. doi: 10.1016/j.jvs.2003.10.064.
PubMed 15071441Katz DJ, Stanley JC, Zelenock GB. Gender differences in abdominal aortic aneurysm prevalence, treatment, and outcome. J Vasc Surg. 1997 Mar;25(3):561-8. doi: 10.1016/s0741-5214(97)70268-4.
PubMed 9081139Scott SW, Batchelder AJ, Kirkbride D, Naylor AR, Thompson JP. Late Survival in Nonoperated Patients with Infrarenal Abdominal Aortic Aneurysm. Eur J Vasc Endovasc Surg. 2016 Oct;52(4):444-449. doi: 10.1016/j.ejvs.2016.05.008. Epub 2016 Jun 30.
PubMed 27374814
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elective Treatment Rates Among Patients With Intact Abdominal Aortic Aneurysms -Patient- and Aneurysm-related Factors as Determinants of Surgical Non-eligibility in Women and Men
- ClinicalTrials.gov ID
- NCT05346289
- Acronym / sponsor ID
- ESPN201689310422
- Conditions
- Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm Without Rupture, Aneurysm, Aortic Aneurysm, Aneurysm Abdominal
- Keywords
- Sex differences, Elective treatment rate, Surgical eligibility, Surgical treatment, Conservative treatment, Untreated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Medical University of Graz, St. Olavs Hospital
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 26 Apr 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.
The overall aim is to determine the frequency by which women and men with intact abdominal aortic aneurysms (AAA) are treated with elective surgery at three vascular outpatient clinics in Europe, and to investigate whether the reasons to refrain from elective surgery differ between the sexes.
Detailed description
Abdominal aortic aneurysm (AAA) is a local widening of the infrarenal aorta (1). The natural history of AAA is progressive and may lead to rupture, a true surgical emergency with a mortality rate of 100% without immediate treatment. Men are more commonly affected (2, 3), however, women demonstrate a notably elevated risk of rupture (4, 5) and constitute up to 1/3 of all ruptures (4, 5). One plausible explanation could be a sex discrepancy in elective treatment rates.
There is both national and international evidence implying that AAA treatments, both elective and emergent, are withheld among women (6-14). Studies on elective treatment rates are especially scarce, as the vast majority of databases and vascular registries only include data on treated AAA patients. A few single-center studies from the UK (6, 7, 15) and one meta-analysis (8) have recorded lower treatment rates among women. We have recently analyzed the issue of elective treatment rates in our group using a population-based approach (manuscript submitted). Of all patients diagnosed with an intact AAA in Sweden during 2001-2015 (n=32 393, 21% women), a crude proportion as high as 60 % did not proceed to receive surgical treatment. The proportion of untreated women (67 %) surpassed that of men (59 %). In the multivariate analyses, female sex and advanced age emerged as the strongest predictors for remaining untreated despite other characteristics such as comorbidities, civil status and individual disposable household income. The median time from diagnosis to treatment for those treated was surprisingly short at 1.6 years.
The foremost intention-to-treat variable that determines the indication for elective surgery is the maximal diameter of the aneurysm (55 mm in men, 50 mm in women; (16, 17)). Population-based investigations, while comprehensive, fall short in terms of aneurysm-specific data. Therefore, these analyses assume comparable diameter distributions and similar morphology for men and women. Similarly, longitudinal follow-up data from the clinical setting, such as records of patient's wishes and physiological preoperative examinations, cannot be extracted for the purpose of nationwide analyses. Thus, the question remains whether the observed gender gap in elective treatment rates persists after detailed considerations of patient- and aneurysm-specific characteristics. A discrepancy in elective treatment rates could also lead to different long-term outcomes, with higher rupture and mortality rates among women.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women | – | Procedure: Elective surgery for intact AAA |
| Men | – | Procedure: Elective surgery for intact AAA |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All men and women diagnosed with an intact abdominal aortic aneurysm (ICD10 classification I71.4) and who fulfill the inclusion diameter criterion and none of the exclusion criteria are consecutively included from January 2014 and onwards at three vascular outpatient departments in Europe (Karolinska University Hospital, Stockholm, Sweden; St. Olav Hospital, Trondheim, Norway; Medical University of Graz, Graz, Austria) until reaching prespecified study target size according to power calculation (200 women, 200 men).
Key inclusion criteria (1 listed)
- Intact abdominal aortic aneurysm 30 mm or larger in men and women irrespective of underlying pathogenesis (atherosclerotic, mycotic, previous dissection).
Key exclusion criteria (2 listed)
- Previous aortic surgery or surgical treatment for AAA
- Ruptured AAA at index contact
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 |
|---|---|---|
| Elective surgery for intact AAAElective surgery including the following modalities: open repair, endovascular repair (EVAR), fenestrated end-vascular repair (FEVAR). | Procedure or surgery | Men, Women |
Primary outcome
Final Elective Treatment Status
Time frame: End of follow-up in December 2021 with maximal possible follow-up of seven years.
Relative frequency of women and men that were electively treated or left untreated, the latter group subcategorized into patients who did or did not reach the diameter threshold for surgical treatment (50 mm women, 55 men).
Sex-Specific Reasons for Remaining Untreated
Time frame: Evaluated at the time of the conservative treatment decision during maximal follow-up of seven years.
Frequency distribution of underlying reasons behind non-treatment among those men and women who reached the treatment threshold. Primary reason registered as patient- (comorbidity, patient's wish) or AAA-related (morphology).
2 secondary outcomes
Rupture Rate
Time frame: Study end December 2021.
Mortality Rate
Time frame: Study end December 2021.
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 5 Dec 2022.
- Background: PubMed 30337540Sakalihasan N, Michel JB, Katsargyris A, Kuivaniemi H, Defraigne JO, Nchimi A, Powell JT, Yoshimura K, Hultgren R. Abdominal aortic aneurysms. Nat Rev Dis Primers. 2018 Oct 18;4(1):34. doi: 10.1038/s41572-018-0030-7.
- Background: PubMed 11436084Lederle FA, Johnson GR, Wilson SE; Aneurysm Detection and Management Veterans Affairs Cooperative Study. Abdominal aortic aneurysm in women. J Vasc Surg. 2001 Jul;34(1):122-6. doi: 10.1067/mva.2001.115275.
- Background: PubMed 11872050Scott RA, Bridgewater SG, Ashton HA. Randomized clinical trial of screening for abdominal aortic aneurysm in women. Br J Surg. 2002 Mar;89(3):283-5. doi: 10.1046/j.0007-1323.2001.02014.x.
- Background: PubMed 22389113Sweeting MJ, Thompson SG, Brown LC, Powell JT; RESCAN collaborators. Meta-analysis of individual patient data to examine factors affecting growth and rupture of small abdominal aortic aneurysms. Br J Surg. 2012 May;99(5):655-65. doi: 10.1002/bjs.8707. Epub 2012 Mar 5.
- Background: PubMed 10493476Brown LC, Powell JT. Risk factors for aneurysm rupture in patients kept under ultrasound surveillance. UK Small Aneurysm Trial Participants. Ann Surg. 1999 Sep;230(3):289-96; discussion 296-7. doi: 10.1097/00000658-199909000-00002.
- Background: PubMed 21576025Karthikesalingam A, Nicoli TK, Holt PJ, Hinchliffe RJ, Pasha N, Loftus IM, Thompson MM. The fate of patients referred to a specialist vascular unit with large infra-renal abdominal aortic aneurysms over a two-year period. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):295-301. doi: 10.1016/j.ejvs.2011.04.022. Epub 2011 May 14.
- Background: PubMed 28874329Whittaker JD, Meecham L, Summerour V, Khalil S, Layton G, Yousif M, Jennings A, Wall M, Newman J. Outcome after Turndown for Elective Abdominal Aortic Aneurysm Surgery. Eur J Vasc Endovasc Surg. 2017 Nov;54(5):579-586. doi: 10.1016/j.ejvs.2017.07.023. Epub 2017 Sep 2.
- Background: PubMed 30057105Sweeting MJ, Masconi KL, Jones E, Ulug P, Glover MJ, Michaels JA, Bown MJ, Powell JT, Thompson SG. Analysis of clinical benefit, harms, and cost-effectiveness of screening women for abdominal aortic aneurysm. Lancet. 2018 Aug 11;392(10146):487-495. doi: 10.1016/S0140-6736(18)31222-4. Epub 2018 Jul 26.
- Background: PubMed 31403186Zommorodi S, Bottai M, Hultgren R. Sex differences in repair rates and outcomes of patients with ruptured abdominal aortic aneurysm. Br J Surg. 2019 Oct;106(11):1480-1487. doi: 10.1002/bjs.11258. Epub 2019 Aug 12.
- Background: PubMed 30395361Aber A, Tong TS, Chilcott J, Thokala P, Maheswaran R, Thomas SM, Nawaz S, Walters S, Michaels J. Sex differences in national rates of repair of emergency abdominal aortic aneurysm. Br J Surg. 2019 Jan;106(1):82-89. doi: 10.1002/bjs.11006. Epub 2018 Nov 5.
- Background: PubMed 28655374Kuhnl A, Erk A, Trenner M, Salvermoser M, Schmid V, Eckstein HH. Incidence, Treatment and Mortality in Patients with Abdominal Aortic Aneurysms. Dtsch Arztebl Int. 2017 Jun 5;114(22-23):391-398. doi: 10.3238/arztebl.2017.0391.
- Background: PubMed 17391899McPhee JT, Hill JS, Eslami MH. The impact of gender on presentation, therapy, and mortality of abdominal aortic aneurysm in the United States, 2001-2004. J Vasc Surg. 2007 May;45(5):891-9. doi: 10.1016/j.jvs.2007.01.043. Epub 2007 Mar 28.
- 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.
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 Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm Without Rupture, run by Karolinska University Hospital at 1 site in Sweden.
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 1 inclusion and 2 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 5 Dec 2022. 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 Sweden. 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?
Final Elective Treatment Status (time frame: End of follow-up in December 2021 with maximal possible follow-up of seven years.). 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 NCT05346289, which also lists 18 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 5 Dec 2022.