Adrenal IncidentalomasCHIRACICNCT02364089
Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas
A study testing Laparoscopic surgical removal of the adrenal tumor and Standardized medical treatment of hypertension by SAHR in people with Adrenal Incidentalomas, run by University Hospital, Bordeaux at 17 sites in 3 countries.
Trial summary
The general objective is to evaluate the consequences of surgical removal of SCSI on hypertension and cardiovascular risk factors in order to determine on an evidence-based basis if surgical excision of SCSI is preferable to an intensive medical regimen in patients with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adrenal Incidentalomas
- What is being tested?
- Laparoscopic surgical removal of the adrenal tumor and Standardized medical treatment of hypertension by SAHR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 9 Apr 2015to 23 Nov 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≤ 80 years.
- Unilateral SCSI:
- Incidentally discovered adrenal tumor with attenuation < 20 UH and/or relative wash-out (> 40%) or absolute wash-out (> 60%) of contrast media and size ≥ 2 cm. Tumors that do not fulfil these criteria might be included if their size is ≤ 4 cm, do not exhibit signs of malignancy (necrosis areas, large and irregular rims) and are stable in size after ≥ 6 months of follow-up.
- Impaired 1 mg dexamethasone suppression (Cortisol > 138 nmol/L or 5 µg/dL), OR Impaired 1 mg dexamethasone suppression (Cortisol > 50 nmol/L or 1.8 µg/dL) AND one biochemical abnormalities among:
- 08h00 plasma ACTH < 2.2 pmol/L or plasma ACTH following CRH injection ≤ 6.6 pmol/L,
- midnight plasma cortisol > 150 nmol/L,
Show all 9Show fewer
- increased late evening salivary cortisol,
- UFC between 1 and 2.0 x N.
- Treated BP (and confirmed using an automated home BP monitoring) OR increased BP (≥ 135/85 mmHg) none treated, using an automated home BP monitoring.
Who cannot join
- Age > 80 y,
- Bilateral SCSI, Warning: Contralateral nodular formations < 10 mm are considered as negligible,
- Incidentally discovered adrenal tumor size < 2 cm,
- Malignant hypertension, stroke, pulmonary oedema or myocardial infarction during the previous year,
- Malignant hypertension during the Run-in period,
- Obligatory beta blocker treatment. Patients receiving betablocker treatment for other purpose than hypertension can be included. However, to be included, patients should need at least an extrastep of hypertensive treatment in order to allow the SAHR decrease following randomisation. The dose of betablocker has to stay the same during all the study.
Show all 19Show fewer
- UFC > ULN x 2.0 N,
- 8h00 plasma ACTH > 20 pg/ml (4.4 pmol/L),
- Chronic renal insufficiency (clearance < 30 mL/min)
- Dissipation of the biological endocrine criteria for SCSI at the end of the Run-In period,
- Intake of exogenous corticoids or drugs that interfere with dexamethasone metabolism,
- Pregnancy,
- Childbearing woman with no contraceptive effective method (HAS criteria - 77),
- Adverse pathological conditions responsible for reduced life expectancy.
- Spontaneous resolution of biological features of SCSI
- Hypertension not confirmed with standard blood pressure self-measurement device
- Hypertension not controlled (≥ 135/85 mmHg) at the end of the Run-In period
- Malignant hypertension (> 175/115 mmHg)
- Patient receiving betablocker and not receiving at least an extrastep of hypertensive treatment of the SAHR
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
France14 sites
Service d'Endocrinologie, Diabétologie, Nutrition - CHU d'Amiens
Amiens, Haut de France, 80000
Département Endocrinologie-Diabétologie -Nutrition - CHU d'ANGERS
Angers, Pays de la Loire Region, 49000
Service d'Endocrinologie - Niveau 18 - Caen CHU Côte de Nacre
Caen, Basse-Normandie, 14000
Service d'Endocrinologie et des Maladies de la Reproduction- Assistance Publique - Hôpitaux de Paris - Hôpial Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, 94275
Service d'Endocrinologie, Diabétologie et Métabolisme - CHRU de LILLE
Lille, Hauts-de-France, 59000
Service d'Endocrinologie, Diabète et Maladies Métaboliques - Assistance publique - Hôpitaux de Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, 13000
CIC Endocrinologie-Nutrition - CHU de Nantes
Nantes, Pays de la Loire Region, 44000
Assistance Publique - Hôpitaux de Paris - Hôpital COCHIN
Paris, Île-de-France Region, 75014
Service d'Hypertension et de Médecine Vasculaire - Assistance Publique - Hôpitaux de Paris - Hôpital européen Georges Pompidou
Paris, Île-de-France Region, 75908
Service Endocrinologie, Diabétologie, maladies métaboliques - CHU de Bordeaux
Pessac, Aquitaine, 33600
CHU de Poitiers
Poitiers, 86021
Endocrinologie, Diabète et Maladies Métaboliques - CHU de Rouen
Rouen, Haute-Normandie, 76000
Service de Médecine Interne, Endocrinologie et Nutrition - CHU de Strasbourg
Strasbourg, Alsace, 67000
Service d'Endocrinologie et Maladies Métabolique - CHU de Toulouse
Toulouse, Midi-Pyrénées, 31000
Germany2 sites
Endokrinologie, Diabetes und Ernährungsmedizin, Campus Mitte, Medizinische Klinik - Charité - Universitätsmedizin Berlin
Berlin, 10117
Department of Internal Medicine I, Endocrine and Diabetes Uni -University Hospital Würzburg
Würzburg, 97080
About this study
The general objective is to evaluate the consequences of surgical removal of SCSI on hypertension and cardiovascular risk factors in order to determine on an evidence-based basis if surgical excision of SCSI is preferable to an intensive medical regimen in patients with hypertension.
Read the detailed description
Adrenal incidentalomas are unsuspected adrenal masses found during abdominal imaging. With the widespread use of computed tomography and MRI, adrenal incidentalomas are found in approximately 2% of patients. In an endocrinology setting, the majority of these masses are benign adenomas of the adrenal cortex. Approximately 10% of these adenomas display little excess of cortisol secretion associated to some degree of secretory autonomy but that are insufficient to generate overt Cushing's syndrome ("Subclinical Secreting Cortisol incidentalomas" or SCSI). However, hypertension and to a lesser degree obesity and impaired glucose tolerance are very frequent amongst patients with SCSI. The hypothesis that the mild hypercortisolism associated with SCSI is responsible for these clinical consequences is substantiated by few studies describing improvement after resection of SCSI. However, these studies were retrospective, uncontrolled and suffered from imprecision and numerous methodological bias. Thus, whether surgery is more beneficial than medical treatment is currently unknown and there is no consensus on the appropriate treatment for SCSI.
Patient selection Run-In period. Discontinuation of previous antihypertensive treatments and prescription of a standardized anti-hypertensive drug regimen (SAHR). Monthly Blood Pressure (BP) measurement using home BP monitoring. The duration of the Run-In periods will be ≤ 6 months and will end when BP will be controlled with the SAHR at two consecutive visits.
End of RI Second endocrine assessment for eligibility Randomization (Ra): 24h Ambulatory BP measurement, anthropometric and metabolic evaluation. Quality of life and cognition questionnaires. Randomization in 2 groups : Gr 1 Treatment group : Surgery followed by intensive medical care ; Gr 2 : Control Group : intensive medical care only.
Ra + 1Mo: Surgery in Group 1 Ra + 2.5 Mo to Ra + 13 Mo: 6 weeks interval follow-up Evaluation of home BP monitoring and adaptation of the SAHR. A step by step reduction of the SAHR will be attempted in the two patient groups at Ra+2.5Mo. A second attempt will systematically be performed in both groups at Ra+8.5 Medical evaluation of associated metabolic conditions (obesity, diabetes, dyslipidemia) and adaptation of treatments Record of medical events and side effects of treatments Ra + 13Mo: Final evaluation. Endocrine assessment. 24h Ambulatory BP measurement, anthropometric and metabolic evaluation. Quality of life and cognition questionnaires.
- Conditions
- Adrenal Incidentalomas
- Being tested
- Laparoscopic surgical removal of the adrenal tumor, Standardized medical treatment of hypertension by SAHR
- Keywords
- Adrenal Incidentaloma, Subclinical Cushing's syndrome, Hypertension, Cardiovascular Risk Factors, Metabolic Syndrome, Surgery of adrenal tumor
- Medical subject headings
- Adrenal incidentaloma, Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgical removal of the adrenal tumorProcedure or surgery
Standardized medical treatment of hypertension by SAHRDrug
Standardized anti-hypertensive drug regimen has been established according to international recommendations and includes the following steps:
- step 1: Angiotensin converting enzyme inhibitor (ACE-I) or angiotensin II receptor antagonist (ARBs) at half-dose (Ranipril 5mg or Ibesartan 150 mg )
- step 2: CEI or ARA2 at full dose (Ranipril 10 mg or Ibesartan 300 mg)
- step 3: Add-on of Amlodipine 10 mg or Diltiazem LP 300 mg
- step 4: Add-on of Indapamide LP 1.5 mg
- step 5: Add-on of Spironolactone 25 mg
- step 6: Add-on of Bisoprolol 10 mg
- step 7: Add-on of Prazosine LP 5mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Surgery followed by intensive medical care | Experimental | Laparoscopic surgical removal of the adrenal tumor Receives: Procedure: Laparoscopic surgical removal of the adrenal tumor |
| Intensive medical treatment only | Active comparator | Standardized medical treatment of hypertension by SAHR. Receives: Drug: Standardized medical treatment of hypertension by SAHR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure value and SAHR step 12 months after inclusion
Treatment response will defined as a reduction of at least 1 step of SAHR at the end of the study, with BP maintained within the study objectives (<135 mm Hg systolic and <85 mm Hg diastolic) according to self-measurement at home.
Measured: 13 months
Secondary outcomes (10)
Antihypertensive treatment score and daily drug dose
Measured: 12 months
Incidence of complications in the two strategies.
Measured: 12 months
Direct costs of the two strategies.
Measured: 12 months
Assessment of predictive factors for the success of surgery on BP
age, family history of hypertension, duration of hypertension, kidney function, biochemical endocrine abnormalities, urinary steroid profile
Measured: 12 months
number of patients requiring antihypertensive treatment
Measured: 12 months
24 hours ambulatory blood pressure monitoring values
Measured: At inclusion (day 0) and at 12 months
Blood glucose and lipid lowering agents values
Measured: 12 months
Cardiovascular risk factors/markers level
Comparison of the two therapeutic strategies with regard to cardiovascular risk factors/markers: BMI, body composition evaluated by DEXA, abdominal fat evaluated on CT-scan, fasting blood glucose and insulin, HbA1C, HOMA-IR (homeostasis model of assessment of insulin resistance) and OGTT (oral glucose tolerance test), blood lipids, pro-inflammatory adipokines
Measured: 12 months
Number of patients with persistent diabetes, dyslipidemia and metabolic syndrome
Measured: 12 months
Evaluation of quality of life
Comparison of the two therapeutic strategies with regard to quality of life
Measured: At inclusion and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study start9 Apr 2015
- Primary completion9 Mar 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal IncidentalomasStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric FRISON, Dr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364089
- Sponsor's protocol ID
- CHUBX 2012/34
- Acronym
- CHIRACIC
- Status last verified
- Jul 2023
- First submitted
- 28 Jan 2015
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tabarin A, Espiard S, Deutschbein T, Amar L, Vezzossi D, Di Dalmazi G, Reznik Y, Young J, Desailloud R, Goichot B, Drui D, Assie G, Lefebvre H, Mai K, Castinetti F, Laboureau S, Terzolo M, Ferriere A, Georget A, Frison E, Vantyghem MC, Fassnacht M, Gosse P; CHIRACIC Collaborators. Surgery for the treatment of arterial hypertension in patients with unilateral adrenal incidentalomas and mild autonomous cortisol secretion (CHIRACIC): a multicentre, open-label, superiority randomised controlled trial. Lancet Diabetes Endocrinol. 2025 Jul;13(7):580-590. doi: 10.1016/S2213-8587(25)00062-2. Epub 2025 May 12.
PubMed 40373786
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas
- ClinicalTrials.gov ID
- NCT02364089
- Acronym / sponsor ID
- CHIRACIC / CHUBX 2012/34
- Conditions
- Adrenal Incidentalomas
- Keywords
- Adrenal Incidentaloma, Subclinical Cushing's syndrome, Hypertension, Cardiovascular Risk Factors, Metabolic Syndrome, Surgery of adrenal tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 Apr 2015 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 16 Feb 2015 (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.
The general objective is to evaluate the consequences of surgical removal of SCSI on hypertension and cardiovascular risk factors in order to determine on an evidence-based basis if surgical excision of SCSI is preferable to an intensive medical regimen in patients with hypertension.
Detailed description
Adrenal incidentalomas are unsuspected adrenal masses found during abdominal imaging. With the widespread use of computed tomography and MRI, adrenal incidentalomas are found in approximately 2% of patients. In an endocrinology setting, the majority of these masses are benign adenomas of the adrenal cortex. Approximately 10% of these adenomas display little excess of cortisol secretion associated to some degree of secretory autonomy but that are insufficient to generate overt Cushing's syndrome ("Subclinical Secreting Cortisol incidentalomas" or SCSI). However, hypertension and to a lesser degree obesity and impaired glucose tolerance are very frequent amongst patients with SCSI. The hypothesis that the mild hypercortisolism associated with SCSI is responsible for these clinical consequences is substantiated by few studies describing improvement after resection of SCSI. However, these studies were retrospective, uncontrolled and suffered from imprecision and numerous methodological bias. Thus, whether surgery is more beneficial than medical treatment is currently unknown and there is no consensus on the appropriate treatment for SCSI.
Patient selection Run-In period. Discontinuation of previous antihypertensive treatments and prescription of a standardized anti-hypertensive drug regimen (SAHR). Monthly Blood Pressure (BP) measurement using home BP monitoring. The duration of the Run-In periods will be ≤ 6 months and will end when BP will be controlled with the SAHR at two consecutive visits.
End of RI Second endocrine assessment for eligibility Randomization (Ra): 24h Ambulatory BP measurement, anthropometric and metabolic evaluation. Quality of life and cognition questionnaires. Randomization in 2 groups : Gr 1 Treatment group : Surgery followed by intensive medical care ; Gr 2 : Control Group : intensive medical care only.
Ra + 1Mo: Surgery in Group 1 Ra + 2.5 Mo to Ra + 13 Mo: 6 weeks interval follow-up Evaluation of home BP monitoring and adaptation of the SAHR. A step by step reduction of the SAHR will be attempted in the two patient groups at Ra+2.5Mo. A second attempt will systematically be performed in both groups at Ra+8.5 Medical evaluation of associated metabolic conditions (obesity, diabetes, dyslipidemia) and adaptation of treatments Record of medical events and side effects of treatments Ra + 13Mo: Final evaluation. Endocrine assessment. 24h Ambulatory BP measurement, anthropometric and metabolic evaluation. Quality of life and cognition questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery followed by intensive medical care | Experimental | Procedure: Laparoscopic surgical removal of the adrenal tumorLaparoscopic surgical removal of the adrenal tumor |
| Intensive medical treatment only | Active comparator | Drug: Standardized medical treatment of hypertension by SAHRStandardized medical treatment of hypertension by SAHR. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≤ 80 years.
- Unilateral SCSI:
Key exclusion criteria (19 listed)
- Age > 80 y,
- Bilateral SCSI, Warning: Contralateral nodular formations < 10 mm are considered as negligible,
- Incidentally discovered adrenal tumor size < 2 cm,
- Malignant hypertension, stroke, pulmonary oedema or myocardial infarction during the previous year,
- Malignant hypertension during the Run-in period,
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 |
|---|---|---|
| Laparoscopic surgical removal of the adrenal tumor | Procedure or surgery | Surgery followed by intensive medical care |
| Standardized medical treatment of hypertension by SAHRStandardized anti-hypertensive drug regimen has been established according to international recommendations and includes the following steps: * step 1: Angiotensin converting enzyme inhibitor (ACE-I) or angiotensin II receptor antagonist (ARBs) at half-dose (Ranipril 5mg or Ibesartan 150 mg ) * step 2: CEI or ARA2 at full dose (Ranipril 10 mg or Ibesartan 300 mg) * step 3: Add-on of Amlodipine 10 mg or Diltiazem LP 300 mg * step 4: Add-on of Indapamide LP 1.5 mg * step 5: Add-on of Spironolactone 25 mg * step 6: Add-on of Bisoprolol 10 mg * step 7: Add-on of Prazosine LP 5mg/day. | Drug | Intensive medical treatment only |
Primary outcome
Blood pressure value and SAHR step 12 months after inclusion
Time frame: 13 months
Treatment response will defined as a reduction of at least 1 step of SAHR at the end of the study, with BP maintained within the study objectives (<135 mm Hg systolic and <85 mm Hg diastolic) according to self-measurement at home.
10 secondary outcomes
Antihypertensive treatment score and daily drug dose
Time frame: 12 months
Incidence of complications in the two strategies.
Time frame: 12 months
Direct costs of the two strategies.
Time frame: 12 months
Assessment of predictive factors for the success of surgery on BP
Time frame: 12 months
number of patients requiring antihypertensive treatment
Time frame: 12 months
24 hours ambulatory blood pressure monitoring values
Time frame: At inclusion (day 0) and at 12 months
Blood glucose and lipid lowering agents values
Time frame: 12 months
Cardiovascular risk factors/markers level
Time frame: 12 months
Number of patients with persistent diabetes, dyslipidemia and metabolic syndrome
Time frame: 12 months
Evaluation of quality of life
Time frame: At inclusion and 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 20 Jul 2023.
- Derived from this study: PubMed 40373786Tabarin A, Espiard S, Deutschbein T, Amar L, Vezzossi D, Di Dalmazi G, Reznik Y, Young J, Desailloud R, Goichot B, Drui D, Assie G, Lefebvre H, Mai K, Castinetti F, Laboureau S, Terzolo M, Ferriere A, Georget A, Frison E, Vantyghem MC, Fassnacht M, Gosse P; CHIRACIC Collaborators. Surgery for the treatment of arterial hypertension in patients with unilateral adrenal incidentalomas and mild autonomous cortisol secretion (CHIRACIC): a multicentre, open-label, superiority randomised controlled trial. Lancet Diabetes Endocrinol. 2025 Jul;13(7):580-590. doi: 10.1016/S2213-8587(25)00062-2. Epub 2025 May 12.
Related trials for Adrenal Incidentalomas
RecruitingObservational study
Cardiovascular Complications After Adrenalectomy for Pheochromocytoma and Non-secreting Tumors
Pheochromocytoma, Cardiovascular Complication
Recruiting
Ultradian Steroid Rhythms in Adrenal Incidentalomas
Mild Autonomous Cortisol Secretion Adenoma, Non Secreting Adenoma
Recruiting
IMPACT-MACS: Adrenalectomy vs Semaglutide for Metabolic Outcomes in Mild Autonomous Cortisol Secretion
Mild Autonomous Cortisol Secretion (MACS), Autonomous Cortisol Secretion (ACS)
RecruitingObservational study
Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma
Mild Autonomous Cortisol Secretion (MACS)
RecruitingObservational study
Artificial Intelligence Used in Screening Adrenal Nodules
Adrenal Incidentalomas, Thoracic CT-scan
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.
Eric FRISON, Dr study chair
University Hospital, Bordeaux
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic surgical removal of the adrenal tumor and Standardized medical treatment of hypertension by SAHR in people with Adrenal Incidentalomas, run by University Hospital, Bordeaux at 17 sites in 3 countries.
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 9 inclusion and 19 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Germany, Italy. 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?
Blood pressure value and SAHR step 12 months after inclusion (time frame: 13 months). 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 NCT02364089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.