Obesity, MorbidNCT03598920
Aspiration Therapy for Obese Adolescents
An observational study of Obesity, Morbid, run by University Hospital Ostrava at 3 sites in Czechia.
Trial summary
Interventional studies devoted to adolescents are relatively rare in the world. This has several reasons. Treatment and research on obesity are centered on advanced forms of obesity in adults, bearing in mind that social and health problems make these patients cope with their condition. Read more about this study
- Who is it for?
- Ages 16 to 21 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- AsspireAssist and Nutritional consulting
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 3 sitesCzechia
- Study dates
- 1 Aug 2018to 31 Dec 2021
- 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 16 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents with malignant obesity (BMI> 40) in range BMI 30-50 kg/m2.
Who may be able to join
- history of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities)
Who cannot join
- Diabetes Type I.
- blood clotting disorder
- using of Insulin
- psychiatric disorders
- monogenic obesity (Prader-Willi syndrome, mutation of MC4R).
- thyroid disease
Show all 9Show fewer
- diseases of the digestive system associated with disorders of intestinal absorption
- history of corticosteroid therapy in the past 12 months
- history of bulimia and other eating disorders
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
Ostrava University
Ostrava, Moravian-Silesian Region, 70103
Vítkovice Hospital Ostrava
Ostrava, Moravian-Silesian Region, 703 00
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
About this study
Official title: Study of Safety and Efficacy Assessment of Aspiration Therapy for Morbidly Obese Adolescents
Interventional studies devoted to adolescents are relatively rare in the world. This has several reasons. Treatment and research on obesity are centered on advanced forms of obesity in adults, bearing in mind that social and health problems make these patients cope with their condition. Studies on children tend to focus on epidemiology. On the other hand, effective long-term effective treatment is not just for young adults and adolescents. However, appropriate long-term weight reduction methods could help with chronic obesity at the onset of the disease. Here, the ideal scheme at the outset of the disease is to use less invasive endoscopic methods and then use invasive surgical methods at a later age.
The benefit of this study will certainly be to find out the reality of the use of this endoscopic method in young obese individuals, that is, population groups where, according to the WHO and CDC (Centers for Disease Control and Prevention), there has been a rapid increase in the incidence of obesity especially during the last 20 years.
Read the detailed description
The aim of the project is the testing and research of the impact on metabolism using the approved bariatric method AspireAssist, which is currently used in the adult population. The method has been approved by FDA since 2016. The method involves the introduction of percutaneous endoscopic gastrostomy (PEG) that allows the aspiration of a portion of the food and the control of the size and volume of the food received, even in the unmanaged size and volume of food intake.
Potential participants of the study will undergo an initial examination at the clinical department of pediatric medicine specializing in obesitology at the Vítkovice Hospital Ostrava a.s. In addition to a pediatric and internal examination, a potential patient will be examined by a clinical psychologist for the ability to participate in such a type of study on a long-term basis, and will further assess the degree of patient support and co-operation. Selected participants in the study or their family members will receive informed consent. A study participant is considered to be a participant in the study after consent to his / her inclusion in the study after the informed consent has been signed. The AspireAssist aspiration device is the definitive participation in the study.
Two parts will be monitored within the project. (1) Safety and efficacy will be assessed first in young obese patients for whom the use of bariatric methods is still a question of discussion, especially in surgical methods. (2) The second objective is to monitor the saccharide and lipid metabolism, GI hormones and also the impact of the AspireAssist method on the nutritional status of the adolescents studied.
The patients enrolled in the study are followed for the period of twelve months.
Timetable of the study procedures and controls:
Preoperative examination:
- Demographic data on age, sex, weight, height, smoking
- Assessment of body composition and sampling of blood
- Questionnaires for the quality of Life Examination 3 months postoperatively
- Assessment of body composition and sampling of blood
- Questionnaires for the quality of Life Examination 6 months after surgery
- Assessment of body composition and sampling of blood
- Questionnaires for the quality of Life Examination 12 months after surgery
- Assessment of body composition and sampling of blood
- Questionnaires for the quality of Life
Statistical data processing for statistical evaluation descriptive statistics is used (arithmetical average, standard deflection, frequency tables), X2 test, Fisher's exact test, analysis of variance (ANOVA), calculating of the OR (odds ratio) with 95 % confidence intervals, and logistic regression. Statistical tests are evaluated at the significance level of 5%. Statistical analysis is performed in the "Stata 10" programme. Program EpiData is used for data collection.
- Conditions
- Obesity, Morbid
- Being tested
- AsspireAssist, Nutritional consulting
- Keywords
- obesity, bariatric medicine, endoscopy treatment, body composition, Adipokines, Ghrelin, Quality of Life, nutrition status, vitamins
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsspireAssistDevice
Endoscopic bariatric procedure using the AsspireAssist device
Nutritional consultingOther
Nutritional consulting provided by a specialized consultant.
| Study group | Role | What they receive |
|---|---|---|
| AspireAssist | Patients undergoing the endoscopic bariatric procedure using the AsspireAssist device Receives: Device: AsspireAssist | |
| Nutritional consulting | Patients undergoing nutritional consulting Receives: Other: Nutritional consulting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term weight reduction assessment in kgs
Evaluation of the success of treatment in terms of long-term weight reduction (difference in body weight in kilograms at the beginning vs. the end of the observation period of 12 months).
Measured: 12 months
Long-term changes of nutritional status
Analysis of the dynamics of changes in nutrition status in adolescents after endoscopic bariatric treatment of obesity (BMI> 30) will be performed. In the study, serum concentrations of the following parameters will be measured: vitamins A, D, E, K, B1, B6, B12, Folic acid and plasma proteins such as albumin, pre albumin, creatinine. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L.
Measured: 12 months
Secondary outcomes (5)
Changes in serum levels of adipose tissue hormones
Analysis of the dynamics of changes in serum levels of adipose tissue hormones (Leptin, Adiponectin) in adolescents after endoscopic bariatric treatment of obesity (BMI> 30) will be performed. Points of measurements: before the planned intervention and then in intervals of 3, 6 and 12 months after procedure.
Measured: 12 months
Changes in serum levels of lipids
Analysis of the dynamics of changes in serum levels of lipids in adolescents after endoscopic bariatric treatment of obesity (BMI> 30) will be performed. In the study, serum concentrations of the following lipids will be measured: triacylglycerols, total cholesterol, high-density lipoprotein, low-density lipoprotein cholesterol, Apo D and Apo E, FGF 21, FGF19, FXR receptor, Omentin 1. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L.
Measured: 12 months
Changes in serum levels GI hormones and saccharide metabolism
Analysis of the dynamics of changes in serum levels of usual panel of GI hormones in adolescents after endoscopic bariatric treatment of malignant obesity (BMI> 35) will be performed. The following serum levels markers of bone resorption and formation will be assessed: fasting glycaemia, insulin and hemoglobin A1C, C-peptide, acylated ghrelin, GLP-1, GIP, PYY. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L.
Measured: 12 months
IWQOL Questionnaire evaluation
Evaluation of effects of endoscopic bariatric interventions on quality of life will be performed by using the IWQOL questionnaire. Improvement from baseline quality of life as measured by standardized IWQOL patient questionnaire (http://www.qualityoflifeconsulting.com/iwqol-lite.html) intended to measure the patient health status.
Measured: 12 months
SF-36 Questionnaire evaluation
Evaluation of effects of different types of bariatric interventions on the quality of life will be performed using the SF-36 questionnaire. Improvement from baseline quality of life as measured by standardized SF-36 patient questionnaire intended to measure the patient health status.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ostrava, Vítkovice Hospital Ostrava, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Evžen Machytka, MD,Ph.D., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598920
- Sponsor's protocol ID
- FNO-IK-Aspiration
- Status last verified
- Dec 2022
- First submitted
- 13 Jun 2018
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not decided to share IPD with other researchers.
Publications
Nystrom M, Machytka E, Noren E, Testoni PA, Janssen I, Turro Homedes J, Espinos Perez JC, Turro Arau R. Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study. Obes Surg. 2018 Jul;28(7):1860-1868. doi: 10.1007/s11695-017-3096-5.
PubMed 29388050Sullivan S, Edmundowicz SA, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: New and Emerging Technologies. Gastroenterology. 2017 May;152(7):1791-1801. doi: 10.1053/j.gastro.2017.01.044. Epub 2017 Feb 10.
PubMed 28192103Abu Dayyeh BK, Edmundowicz S, Thompson CC. Clinical Practice Update: Expert Review on Endoscopic Bariatric Therapies. Gastroenterology. 2017 Mar;152(4):716-729. doi: 10.1053/j.gastro.2017.01.035. Epub 2017 Jan 29.
PubMed 28147221Kumar N, Sullivan S, Thompson CC. The role of endoscopic therapy in obesity management: intragastric balloons and aspiration therapy. Diabetes Metab Syndr Obes. 2017 Jul 6;10:311-316. doi: 10.2147/DMSO.S95118. eCollection 2017.
PubMed 28740414Sullivan S. Aspiration Therapy for Obesity. Gastrointest Endosc Clin N Am. 2017 Apr;27(2):277-288. doi: 10.1016/j.giec.2016.12.001.
PubMed 28292406Kumbhari V, Okolo PI III. Editorial: Aspiration Therapy for Weight Loss: Is the Squeeze worth the Juice? Am J Gastroenterol. 2017 Mar;112(3):458-589. doi: 10.1038/ajg.2017.2.
PubMed 28270668ASGE Bariatric Endoscopy Task Force; ASGE Technology Committee; Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, Banerjee S. Endoscopic bariatric therapies. Gastrointest Endosc. 2015 May;81(5):1073-86. doi: 10.1016/j.gie.2015.02.023. Epub 2015 Mar 28. No abstract available.
PubMed 25828245Devault KR. Could aspiration therapy for obesity be an effective and safe alternative to traditional bariatric surgery? Gastroenterology. 2013 Dec;145(6):1188-90. doi: 10.1053/j.gastro.2013.10.038. No abstract available.
PubMed 24409479Sullivan S, Stein R, Jonnalagadda S, Mullady D, Edmundowicz S. Aspiration therapy leads to weight loss in obese subjects: a pilot study. Gastroenterology. 2013 Dec;145(6):1245-52.e1-5. doi: 10.1053/j.gastro.2013.08.056. Epub 2013 Sep 6.
PubMed 24012983Forssell H, Noren E. A novel endoscopic weight loss therapy using gastric aspiration: results after 6 months. Endoscopy. 2015 Jan;47(1):68-71. doi: 10.1055/s-0034-1378097. Epub 2014 Sep 30.
PubMed 25268305
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety and Efficacy Assessment of Aspiration Therapy for Morbidly Obese Adolescents
- ClinicalTrials.gov ID
- NCT03598920
- Acronym / sponsor ID
- FNO-IK-Aspiration
- Conditions
- Obesity, Morbid
- Keywords
- obesity, bariatric medicine, endoscopy treatment, body composition, Adipokines, Ghrelin, Quality of Life, nutrition status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University of Ostrava, Vítkovice Hospital Ostrava, Czech Republic
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Jul 2018 (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.
Interventional studies devoted to adolescents are relatively rare in the world. This has several reasons. Treatment and research on obesity are centered on advanced forms of obesity in adults, bearing in mind that social and health problems make these patients cope with their condition. Studies on children tend to focus on epidemiology. On the other hand, effective long-term effective treatment is not just for young adults and adolescents. However, appropriate long-term weight reduction methods could help with chronic obesity at the onset of the disease. Here, the ideal scheme at the outset of the disease is to use less invasive endoscopic methods and then use invasive surgical methods at a later age.
The benefit of this study will certainly be to find out the reality of the use of this endoscopic method in young obese individuals, that is, population groups where, according to the WHO and CDC (Centers for Disease Control and Prevention), there has been a rapid increase in the incidence of obesity especially during the last 20 years.
Detailed description
The aim of the project is the testing and research of the impact on metabolism using the approved bariatric method AspireAssist, which is currently used in the adult population. The method has been approved by FDA since 2016. The method involves the introduction of percutaneous endoscopic gastrostomy (PEG) that allows the aspiration of a portion of the food and the control of the size and volume of the food received, even in the unmanaged size and volume of food intake.
Potential participants of the study will undergo an initial examination at the clinical department of pediatric medicine specializing in obesitology at the Vítkovice Hospital Ostrava a.s. In addition to a pediatric and internal examination, a potential patient will be examined by a clinical psychologist for the ability to participate in such a type of study on a long-term basis, and will further assess the degree of patient support and co-operation. Selected participants in the study or their family members will receive informed consent. A study participant is considered to be a participant in the study after consent to his / her inclusion in the study after the informed consent has been signed. The AspireAssist aspiration device is the definitive participation in the study.
Two parts will be monitored within the project. (1) Safety and efficacy will be assessed first in young obese patients for whom the use of bariatric methods is still a question of discussion, especially in surgical methods. (2) The second objective is to monitor the saccharide and lipid metabolism, GI hormones and also the impact of the AspireAssist method on the nutritional status of the adolescents studied.
The patients enrolled in the study are followed for the period of twelve months.
Timetable of the study procedures and controls:
Preoperative examination:
- Demographic data on age, sex, weight, height, smoking
- Assessment of body composition and sampling of blood
- Questionnaires for the quality of Life Examination 3 months postoperatively
- Assessment of body composition and sampling of blood
- Questionnaires for the quality of Life Examination 6 months after surgery
- Assessment of body composition and sampling of blood
- Questionnaires for the quality of Life Examination 12 months after surgery
- Assessment of body composition and sampling of blood
- Questionnaires for the quality of Life
Statistical data processing for statistical evaluation descriptive statistics is used (arithmetical average, standard deflection, frequency tables), X2 test, Fisher's exact test, analysis of variance (ANOVA), calculating of the OR (odds ratio) with 95 % confidence intervals, and logistic regression. Statistical tests are evaluated at the significance level of 5%. Statistical analysis is performed in the "Stata 10" programme. Program EpiData is used for data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AspireAssist | – | Device: AsspireAssistPatients undergoing the endoscopic bariatric procedure using the AsspireAssist device |
| Nutritional consulting | – | Other: Nutritional consultingPatients undergoing nutritional consulting |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with malignant obesity (BMI> 40) in range BMI 30-50 kg/m2.
Key inclusion criteria (1 listed)
- history of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities)
Key exclusion criteria (9 listed)
- Diabetes Type I.
- blood clotting disorder
- using of Insulin
- psychiatric disorders
- monogenic obesity (Prader-Willi syndrome, mutation of MC4R).
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 |
|---|---|---|
| AsspireAssistEndoscopic bariatric procedure using the AsspireAssist device | Device | AspireAssist |
| Nutritional consultingNutritional consulting provided by a specialized consultant. | Other | Nutritional consulting |
Primary outcome
Long-term weight reduction assessment in kgs
Time frame: 12 months
Evaluation of the success of treatment in terms of long-term weight reduction (difference in body weight in kilograms at the beginning vs. the end of the observation period of 12 months).
Long-term changes of nutritional status
Time frame: 12 months
Analysis of the dynamics of changes in nutrition status in adolescents after endoscopic bariatric treatment of obesity (BMI> 30) will be performed. In the study, serum concentrations of the following parameters will be measured: vitamins A, D, E, K, B1, B6, B12, Folic acid and plasma proteins such as albumin, pre albumin, creatinine. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L.
5 secondary outcomes
Changes in serum levels of adipose tissue hormones
Time frame: 12 months
Changes in serum levels of lipids
Time frame: 12 months
Changes in serum levels GI hormones and saccharide metabolism
Time frame: 12 months
IWQOL Questionnaire evaluation
Time frame: 12 months
SF-36 Questionnaire evaluation
Time frame: 12 months
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 7 Dec 2022.
- Background: PubMed 29388050Nystrom M, Machytka E, Noren E, Testoni PA, Janssen I, Turro Homedes J, Espinos Perez JC, Turro Arau R. Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study. Obes Surg. 2018 Jul;28(7):1860-1868. doi: 10.1007/s11695-017-3096-5.
- Background: PubMed 28192103Sullivan S, Edmundowicz SA, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: New and Emerging Technologies. Gastroenterology. 2017 May;152(7):1791-1801. doi: 10.1053/j.gastro.2017.01.044. Epub 2017 Feb 10.
- Background: PubMed 28147221Abu Dayyeh BK, Edmundowicz S, Thompson CC. Clinical Practice Update: Expert Review on Endoscopic Bariatric Therapies. Gastroenterology. 2017 Mar;152(4):716-729. doi: 10.1053/j.gastro.2017.01.035. Epub 2017 Jan 29.
- Background: PubMed 28740414Kumar N, Sullivan S, Thompson CC. The role of endoscopic therapy in obesity management: intragastric balloons and aspiration therapy. Diabetes Metab Syndr Obes. 2017 Jul 6;10:311-316. doi: 10.2147/DMSO.S95118. eCollection 2017.
- Background: PubMed 28292406Sullivan S. Aspiration Therapy for Obesity. Gastrointest Endosc Clin N Am. 2017 Apr;27(2):277-288. doi: 10.1016/j.giec.2016.12.001.
- Background: PubMed 28270668Kumbhari V, Okolo PI III. Editorial: Aspiration Therapy for Weight Loss: Is the Squeeze worth the Juice? Am J Gastroenterol. 2017 Mar;112(3):458-589. doi: 10.1038/ajg.2017.2.
- Background: PubMed 25828245ASGE Bariatric Endoscopy Task Force; ASGE Technology Committee; Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, Banerjee S. Endoscopic bariatric therapies. Gastrointest Endosc. 2015 May;81(5):1073-86. doi: 10.1016/j.gie.2015.02.023. Epub 2015 Mar 28. No abstract available.
- Background: PubMed 24409479Devault KR. Could aspiration therapy for obesity be an effective and safe alternative to traditional bariatric surgery? Gastroenterology. 2013 Dec;145(6):1188-90. doi: 10.1053/j.gastro.2013.10.038. No abstract available.
- Background: PubMed 24012983Sullivan S, Stein R, Jonnalagadda S, Mullady D, Edmundowicz S. Aspiration therapy leads to weight loss in obese subjects: a pilot study. Gastroenterology. 2013 Dec;145(6):1245-52.e1-5. doi: 10.1053/j.gastro.2013.08.056. Epub 2013 Sep 6.
- Background: PubMed 25268305Forssell H, Noren E. A novel endoscopic weight loss therapy using gastric aspiration: results after 6 months. Endoscopy. 2015 Jan;47(1):68-71. doi: 10.1055/s-0034-1378097. Epub 2014 Sep 30.
- Individual participant dataSharing planned: Undecided. The investigators have not decided to share IPD with other researchers.
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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.
Evžen Machytka, MD,Ph.D. principal investigator
University Hospital Ostrava
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by University Hospital Ostrava at 3 sites in Czechia.
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 9 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 7 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 3 sites in Czechia. 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?
Long-term weight reduction assessment in kgs (time frame: 12 months). 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 NCT03598920, which also lists 10 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 7 Dec 2022.