ObesityfibrotaNCT01655017
Fibrosis a New Pathological Actor in Adipose Tissue
A study testing biopsy in people with Obesity and Metabolic Diseases, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Adipose tissue (AT) has specific alterations in obesity in particular increased fibrosis amount compared to lean subjects. Fibrosis amount measured by immunohistochemistry on adipose biopsies appears to to predict weight loss response after a bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Diseases, Fibrosis
- What is being tested?
- biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Feb 2012to 6 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese population :
- Obesity with BMI> 40 kg/m² or obesity with BMI >35 kg/m² with comorbidities (OSA, type 2 diabetes, hypertension etc…)
- Age: 18-65
- weight stable for three months preceding surgery
- candidate to a sleeve or bypass or adjustable gastric banding
- Controls:
Show all 10Show fewer
- BMI< 30 kg/m²
- Age: 18-65
- non inflammatory acute or chronic disease
- candidate to a programmed non inflammatory abdominal surgery
Who cannot join
- Inflammatory disease
- Pregnancy
- cancer
- Drugs (AINS)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Chirurgie générale et digestive et d'oncologie du Pr Nordlinger -Ambroise Paré
Boulogne, 92100
Service de nutrition du Pr Basdevant -Pitié salpêtrière/ Institut Cardiometabolism and nutrition
Paris, 75013
About this study
Adipose tissue (AT) has specific alterations in obesity in particular increased fibrosis amount compared to lean subjects. Fibrosis amount measured by immunohistochemistry on adipose biopsies appears to to predict weight loss response after a bariatric surgery. Non invasive tools to measure fibrosis needs to be validated. The investigators primary aim is to validate a new device able to measure adipose tissue stiffness.
Thus the investigators plan to compare the stiffness results obtained with the device to the quantification of fibrosis using immuno-chemistry in massively obese patient's candidates to a bariatric surgery.
Read the detailed description
Adipose tissue (AT) has specific alterations in obesity that could link obesity to its comorbidities. In particular increased fibrosis abundance in AT has been observed in obese compared to lean subjects. The investigators previously observed that the amount of fibrosis in AT measured at baseline could predict surgery-induced weight loss. Patient with the higher amount of fibrosis at baseline were those who lost less fat mass one year after surgery.
To date fibrosis can only be measured using by immunohistochemistry after surgical biopsy. To that prospect, non invasive tools need to be validated, in particular device able to measure adipose tissue stiffness. The investigators hypothesis is that this new device is as powerful as IHC-quantified fibrosis to predict surgery induced weight loss.
To answer that question the investigators will evaluate adipose tissue stiffness with the device as well as quantify fibrosis using immuno-chemistry on AT biopsy in morbidly obese patients before and during the first year after a bariatric surgery.
The first objective is to validate the investigators new device by comparing both invasive fibrosis measurement on adipose tissue and non invasive stiffness measure The investigators second objective is to assess whether the investigators device can predict weight loss repose after bariatric surgery.
This project is based on a clinical protocol performed in massively obese subjects (BMI>40 kg/m² or BMI>35kg/m² with comorbidities). The investigators will recruit 250 obese patients addressed for bariatric surgery (bypass, sleeve or gastric banding). Clinical phenotype, biochemical analysis, body composition, systemic inflammation, adipose tissue biopsy (to evaluate inflammation and fibrosis) will be assessed at baseline and 3 and 12 months after surgery. Also at baseline surgical sub cutaneous and omental adipose tissue (to evaluate inflammation and fibrosis) as well as liver biopsy (to score non alcoholic hepatitis) will be analysed. 50 non obese patients will serve as controls. Adipose tissue stiffness measured with the device as well as fibrosis quantification on subcutaneous and omental adipose tissue will be assessed at baseline during programmed non inflammatory abdominal surgery Associations between all clinical and biological parameters will be assessed at the different point of the follow up.
More generally, this project might lead us to elucidate whether fibrosis in adipose tissue can predict surgery outcome in terms of weight loss and obesity related complications improvement. Also the investigators want to validate a new non invasive tool to measure adipose tissue fibrosis and check whether it can predict surgery outcomes.
- Conditions
- Obesity, Metabolic Diseases, Fibrosis, Body Weight
- Being tested
- biopsy
- Keywords
- Obesity, adipose tissue fibrosis, Adipose tissue inflammation, Low grade systemic inflammation, non invasive device, Bariatric surgery
- Medical subject headings
- Obesity, Metabolic Diseases, Fibrosis, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyProcedure or surgery
adipose tissue biopsy (to evaluate inflammation and fibrosis)
| Study group | Role | What they receive |
|---|---|---|
| biopsy | Experimental | Obesity with BMI> 40 kg/m² or obesity with BMI between >35 kg/m² with comorbidities (OSA, type 2 diabetes, hypertension etc…) Receives: Procedure: biopsy |
| healthy volunteers | No intervention | biopsy during a surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue stiffness and fibrosis
In both massively obese patients and in a subgroup of lean and overweight control, adipose tissue stiffness will be assessed using the elastography non invasive device. Adipose tissue fibrosis will be evaluated using immuno-chemistry staining upon adipose tissue surgical biopsy and defined as the ratio of the surface stained with picrosirius and the surface of the biopsy. The investigators will then look for a strong statistical association between those two measures to validate our new device.
Measured: baseline
Secondary outcomes (8)
weight loss one year after surgery
The investigators will separate our massively obese patients in tertiles upon weight loss importance one year after surgery and evaluate whether those who lose the most important amount of weight are those who had the less adipose tissue stiffness before the surgery
Measured: 12 months
Severity of obesity related disease before surgery (in particular NASH acknowledged on liver histology)
The investigators will evaluate whether we find a significant correlation between the severity of obesity related disease and the adipose tissue stiffness at baseline.
Measured: baseline
Obesity related disease improvement one year after surgery.
The investigators will check whether patients with the less important adipose tissue stiffness are those who improve the most their obesity related disease (separating our population in two those who improve and those who don't)
Measured: 12 months
Adipose tissue fibrosis and weight loss response
The investigators will quantify adipose tissue fibrosis using picrosirius staining on surgical adipose tissue and evaluate whether the amount of fibrosis at three months negatively correlates with weight loss.
Measured: 3 months
Adipose tissue stiffness and weight loss response
The investigators will quantify adipose stiffness using the non invasive device and evaluate whether the severity of adipose stiffness at three months negatively correlates with weight loss.
Measured: 3 months
Adipose tissue fibrosis and weight loss response.
The investigators will quantify adipose tissue fibrosis using picrosirius staining on surgical adipose tissue and evaluate whether the amount of fibrosis at 12 months negatively correlates with weight loss.
Measured: 12 months
Adipose tissue stiffness and the severity of obesity related disease.
evaluate whether the patients who improve the most their obesity related disease in the short term are those who decreases the most their adipose stiffness.
Measured: 3 months
Adipose tissue stiffness and the severity of obesity related disease.
evaluate whether the patients who improve the most their obesity related disease in the long term are those who decreases the most their adipose stiffness
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 posted1 Aug 2012 (estimated)
- Study start8 Feb 2012
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Aron-wisnewsky, MD, Principal investigator, APHPKarine Clement, MD, PhD, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655017
- Sponsor's protocol ID
- P100503
- Acronym
- fibrota
- Status last verified
- Nov 2020
- First submitted
- 25 Apr 2012
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Roca-Rivada A, Do Cruzeiro M, Denis RG, Zhang Q, Rouault C, Rouille Y, Launay JM, Cruciani-Guglielmacci C, Mattot V, Clement K, Jockers R, Dam J. Whole-body deletion of Endospanin 1 protects from obesity-associated deleterious metabolic alterations. JCI Insight. 2024 Apr 2;9(9):e168418. doi: 10.1172/jci.insight.168418.
PubMed 38716728Torres L, Camila Goncalves Miranda M, Dantas Martins V, Caixeta F, de Almeida Oliveira M, Martins Trindade L, Carvalho de Assis H, Nascimento V, Pinheiro Rosa N, Gomes E, Oliveira Almeida S, Marquet F, Genser L, Marcelin G, Clement K, Russo M, Maria Caetano Faria A, Uceli Maioli T. Obesity-induced hyperglycemia impairs oral tolerance induction and aggravates food allergy. Mucosal Immunol. 2023 Aug;16(4):513-526. doi: 10.1016/j.mucimm.2023.05.008. Epub 2023 Jun 10.
PubMed 37302712Bel Lassen P, Nori N, Bedossa P, Genser L, Aron-Wisnewsky J, Poitou C, Surabattula R, Juul Nielsen M, Asser Karsdal M, Julie Leeming D, Schuppan D, Clement K. Fibrogenesis Marker PRO-C3 Is Higher in Advanced Liver Fibrosis and Improves in Patients Undergoing Bariatric Surgery. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1356-e1366. doi: 10.1210/clinem/dgab897.
PubMed 34905051Rouault C, Marcelin G, Adriouch S, Rose C, Genser L, Ambrosini M, Bichet JC, Zhang Y, Marquet F, Aron-Wisnewsky J, Poitou C, Andre S, Derumeaux G, Guerre-Millo M, Clement K. Senescence-associated beta-galactosidase in subcutaneous adipose tissue associates with altered glycaemic status and truncal fat in severe obesity. Diabetologia. 2021 Jan;64(1):240-254. doi: 10.1007/s00125-020-05307-0. Epub 2020 Oct 30.
PubMed 33125520Bel Lassen P, Charlotte F, Liu Y, Bedossa P, Le Naour G, Tordjman J, Poitou C, Bouillot JL, Genser L, Zucker JD, Sokolovska N, Aron-Wisnewsky J, Clement K. The FAT Score, a Fibrosis Score of Adipose Tissue: Predicting Weight-Loss Outcome After Gastric Bypass. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2443-2453. doi: 10.1210/jc.2017-00138.
PubMed 28419237Liu Y, Aron-Wisnewsky J, Marcelin G, Genser L, Le Naour G, Torcivia A, Bauvois B, Bouchet S, Pelloux V, Sasso M, Miette V, Tordjman J, Clement K. Accumulation and Changes in Composition of Collagens in Subcutaneous Adipose Tissue After Bariatric Surgery. J Clin Endocrinol Metab. 2016 Jan;101(1):293-304. doi: 10.1210/jc.2015-3348. Epub 2015 Nov 19.
PubMed 26583585Verger EO, Aron-Wisnewsky J, Dao MC, Kayser BD, Oppert JM, Bouillot JL, Torcivia A, Clement K. Micronutrient and Protein Deficiencies After Gastric Bypass and Sleeve Gastrectomy: a 1-year Follow-up. Obes Surg. 2016 Apr;26(4):785-96. doi: 10.1007/s11695-015-1803-7.
PubMed 26205215
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrosis a New Pathological Actor in Adipose Tissue
- ClinicalTrials.gov ID
- NCT01655017
- Acronym / sponsor ID
- fibrota / P100503
- Conditions
- Obesity, Metabolic Diseases, Fibrosis, Body Weight
- Keywords
- Obesity, adipose tissue fibrosis, Adipose tissue inflammation, Low grade systemic inflammation, non invasive device, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Feb 2012 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 1 Aug 2012 (estimated)
- 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.
Adipose tissue (AT) has specific alterations in obesity in particular increased fibrosis amount compared to lean subjects. Fibrosis amount measured by immunohistochemistry on adipose biopsies appears to to predict weight loss response after a bariatric surgery. Non invasive tools to measure fibrosis needs to be validated. The investigators primary aim is to validate a new device able to measure adipose tissue stiffness.
Thus the investigators plan to compare the stiffness results obtained with the device to the quantification of fibrosis using immuno-chemistry in massively obese patient's candidates to a bariatric surgery.
Detailed description
Adipose tissue (AT) has specific alterations in obesity that could link obesity to its comorbidities. In particular increased fibrosis abundance in AT has been observed in obese compared to lean subjects. The investigators previously observed that the amount of fibrosis in AT measured at baseline could predict surgery-induced weight loss. Patient with the higher amount of fibrosis at baseline were those who lost less fat mass one year after surgery.
To date fibrosis can only be measured using by immunohistochemistry after surgical biopsy. To that prospect, non invasive tools need to be validated, in particular device able to measure adipose tissue stiffness. The investigators hypothesis is that this new device is as powerful as IHC-quantified fibrosis to predict surgery induced weight loss.
To answer that question the investigators will evaluate adipose tissue stiffness with the device as well as quantify fibrosis using immuno-chemistry on AT biopsy in morbidly obese patients before and during the first year after a bariatric surgery.
The first objective is to validate the investigators new device by comparing both invasive fibrosis measurement on adipose tissue and non invasive stiffness measure The investigators second objective is to assess whether the investigators device can predict weight loss repose after bariatric surgery.
This project is based on a clinical protocol performed in massively obese subjects (BMI>40 kg/m² or BMI>35kg/m² with comorbidities). The investigators will recruit 250 obese patients addressed for bariatric surgery (bypass, sleeve or gastric banding). Clinical phenotype, biochemical analysis, body composition, systemic inflammation, adipose tissue biopsy (to evaluate inflammation and fibrosis) will be assessed at baseline and 3 and 12 months after surgery. Also at baseline surgical sub cutaneous and omental adipose tissue (to evaluate inflammation and fibrosis) as well as liver biopsy (to score non alcoholic hepatitis) will be analysed. 50 non obese patients will serve as controls. Adipose tissue stiffness measured with the device as well as fibrosis quantification on subcutaneous and omental adipose tissue will be assessed at baseline during programmed non inflammatory abdominal surgery Associations between all clinical and biological parameters will be assessed at the different point of the follow up.
More generally, this project might lead us to elucidate whether fibrosis in adipose tissue can predict surgery outcome in terms of weight loss and obesity related complications improvement. Also the investigators want to validate a new non invasive tool to measure adipose tissue fibrosis and check whether it can predict surgery outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biopsy | Experimental | Procedure: biopsyObesity with BMI> 40 kg/m² or obesity with BMI between >35 kg/m² with comorbidities (OSA, type 2 diabetes, hypertension etc…) |
| healthy volunteers | No intervention | –biopsy during a surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Obesity with BMI> 40 kg/m² or obesity with BMI >35 kg/m² with comorbidities (OSA, type 2 diabetes, hypertension etc…)
- Age: 18-65
- weight stable for three months preceding surgery
- candidate to a sleeve or bypass or adjustable gastric banding
- BMI< 30 kg/m²
Key exclusion criteria (4 listed)
- Inflammatory disease
- Pregnancy
- cancer
- Drugs (AINS)
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 |
|---|---|---|
| biopsyadipose tissue biopsy (to evaluate inflammation and fibrosis) | Procedure or surgery | biopsy |
Primary outcome
Adipose tissue stiffness and fibrosis
Time frame: baseline
In both massively obese patients and in a subgroup of lean and overweight control, adipose tissue stiffness will be assessed using the elastography non invasive device. Adipose tissue fibrosis will be evaluated using immuno-chemistry staining upon adipose tissue surgical biopsy and defined as the ratio of the surface stained with picrosirius and the surface of the biopsy. The investigators will then look for a strong statistical association between those two measures to validate our new device.
8 secondary outcomes
weight loss one year after surgery
Time frame: 12 months
Severity of obesity related disease before surgery (in particular NASH acknowledged on liver histology)
Time frame: baseline
Obesity related disease improvement one year after surgery.
Time frame: 12 months
Adipose tissue fibrosis and weight loss response
Time frame: 3 months
Adipose tissue stiffness and weight loss response
Time frame: 3 months
Adipose tissue fibrosis and weight loss response.
Time frame: 12 months
Adipose tissue stiffness and the severity of obesity related disease.
Time frame: 3 months
Adipose tissue stiffness and the severity of obesity related disease.
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 13 Nov 2020.
- Derived from this study: PubMed 38716728Roca-Rivada A, Do Cruzeiro M, Denis RG, Zhang Q, Rouault C, Rouille Y, Launay JM, Cruciani-Guglielmacci C, Mattot V, Clement K, Jockers R, Dam J. Whole-body deletion of Endospanin 1 protects from obesity-associated deleterious metabolic alterations. JCI Insight. 2024 Apr 2;9(9):e168418. doi: 10.1172/jci.insight.168418.
- Derived from this study: PubMed 37302712Torres L, Camila Goncalves Miranda M, Dantas Martins V, Caixeta F, de Almeida Oliveira M, Martins Trindade L, Carvalho de Assis H, Nascimento V, Pinheiro Rosa N, Gomes E, Oliveira Almeida S, Marquet F, Genser L, Marcelin G, Clement K, Russo M, Maria Caetano Faria A, Uceli Maioli T. Obesity-induced hyperglycemia impairs oral tolerance induction and aggravates food allergy. Mucosal Immunol. 2023 Aug;16(4):513-526. doi: 10.1016/j.mucimm.2023.05.008. Epub 2023 Jun 10.
- Derived from this study: PubMed 34905051Bel Lassen P, Nori N, Bedossa P, Genser L, Aron-Wisnewsky J, Poitou C, Surabattula R, Juul Nielsen M, Asser Karsdal M, Julie Leeming D, Schuppan D, Clement K. Fibrogenesis Marker PRO-C3 Is Higher in Advanced Liver Fibrosis and Improves in Patients Undergoing Bariatric Surgery. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1356-e1366. doi: 10.1210/clinem/dgab897.
- Derived from this study: PubMed 33125520Rouault C, Marcelin G, Adriouch S, Rose C, Genser L, Ambrosini M, Bichet JC, Zhang Y, Marquet F, Aron-Wisnewsky J, Poitou C, Andre S, Derumeaux G, Guerre-Millo M, Clement K. Senescence-associated beta-galactosidase in subcutaneous adipose tissue associates with altered glycaemic status and truncal fat in severe obesity. Diabetologia. 2021 Jan;64(1):240-254. doi: 10.1007/s00125-020-05307-0. Epub 2020 Oct 30.
- Derived from this study: PubMed 28419237Bel Lassen P, Charlotte F, Liu Y, Bedossa P, Le Naour G, Tordjman J, Poitou C, Bouillot JL, Genser L, Zucker JD, Sokolovska N, Aron-Wisnewsky J, Clement K. The FAT Score, a Fibrosis Score of Adipose Tissue: Predicting Weight-Loss Outcome After Gastric Bypass. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2443-2453. doi: 10.1210/jc.2017-00138.
- Derived from this study: PubMed 26583585Liu Y, Aron-Wisnewsky J, Marcelin G, Genser L, Le Naour G, Torcivia A, Bauvois B, Bouchet S, Pelloux V, Sasso M, Miette V, Tordjman J, Clement K. Accumulation and Changes in Composition of Collagens in Subcutaneous Adipose Tissue After Bariatric Surgery. J Clin Endocrinol Metab. 2016 Jan;101(1):293-304. doi: 10.1210/jc.2015-3348. Epub 2015 Nov 19.
- Derived from this study: PubMed 26205215Verger EO, Aron-Wisnewsky J, Dao MC, Kayser BD, Oppert JM, Bouillot JL, Torcivia A, Clement K. Micronutrient and Protein Deficiencies After Gastric Bypass and Sleeve Gastrectomy: a 1-year Follow-up. Obes Surg. 2016 Apr;26(4):785-96. doi: 10.1007/s11695-015-1803-7.
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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.
Judith Aron-wisnewsky, MD principal investigator
APHP
Karine Clement, MD, PhD study director
APHP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy in people with Obesity and Metabolic Diseases, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Adipose tissue stiffness and fibrosis (time frame: baseline). 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 NCT01655017, which also lists 7 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 13 Nov 2020.