Crohn DiseaseNCT01738529
Characterization of Crohn's Disease at Confocal Laser Endomicroscopy (CLE) and Related to Disease Activity
A study testing CLE ileocolonoscopy in people with Crohn Disease, run by Herlev Hospital at 1 site in Denmark.
Trial summary
A blinded prospective observation and methodology study with Confocal Laser Endomicroscopy (CLE) together with standard white light colonoscopy including inter- and intra-observation of patients with Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- CLE ileocolonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Feb 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Crohn's disease and involvement of the ileum and / or colon
- Patients must be of legal age
- Shall be given written consent
- Both patients with the activity of their disease patients in remission on biological treatment including can be included
- The control group will consist of patients without known or suspected IBD
Who cannot join
- Increased p-creatinine
- Demonstrated allergy to fluorescein
- Pregnant woman
- Lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Crohn's Disease at Confocal Laser Endomicroscopy and Related to Disease Activity
A blinded prospective observation and methodology study with Confocal Laser Endomicroscopy (CLE) together with standard white light colonoscopy including inter- and intra-observation of patients with Crohn's disease.
Read the detailed description
Introduction: Crohn's disease is a well-characterized disease, and treatment is carried out according to international guidelines. Despite this, the disease often show an individual, unpredictable course, and more than half of patients experience significant complications of the disease. Endoscopy is important for the assessment of disease dissemination and severity of Crohn's disease, which is complemented by biochemical and clinical indices, including CDAI or Simple Index (SI) (Harwey-Bradshaw), which is internationally recognized. By CDAI, there is shown a good correlation with the biochemical activity markers such as CRP, and serum albumin, and in practice the simplified version (SI). Is often used.
Knowledge about the use of CLE in Crohn's disease is very low. We will on the basis of parameters suggested in smaller studies and our personal CLE experience determine which parameters are useful for a precise estimation of the severity of Crohn's disease. Since the disease is most commonly seen in the terminal ileum, the parameters should apply to both the ileum and colon.
A group Crohn patients have long been in prolonged biochemical and conventional endoscopic remission, including patients treated with the biologic drug infliximab. These patients are also included in the study as a particularly interesting subgroup as CLE in a small study has suggested to contribute to the safe discontinuation of immunosuppressive therapy. The degree of healing of the mucous membrane including an intact barrier function is one of the most important prognostic factors for patients to develop a recurrence. Thus it will be of great clinical importance to clarify whether CLE can help to distinguish those patients who have an apparently normal endoscopy, yet unrealized discrete activity and defective barrier function from patients where there is no activity evaluated endoscopically and by CLE. Furthermore, a small number of patients will be included as a control group.
Hypothesis: CLE can characterize Crohn's disease and activity precisely in the ileum and colon compared with conventional ileocolonoscopy, including detecting slight degrees and wider dissemination of inflammation that would otherwise not be recognized.
Design: A blinded prospective observation and method study of patients with subsequent calculation of intra-and inter-observer variability.
Method: The patients enrolled including the control group, will be investigated respectively, by conventional colonoscopy and CLE in both the terminal ileum as colon. The degree and extent of Crohn's disease are assessed by conventional ileocolonoscopy (SI), CLE (selected parameters) and histology biopsies. Terminal ileum and each colonic segment (caecum, ascending colon, transversal colon, descending colon, colon sigmoid and rectum) are assessed as described above. Then, the correlation between histology (gold standard), SI and CLE is calculated. An intra-and inter-observer study follows on CLE parameters, where 3 observers are blinded with respect to each other. The pathologist is blinded to conventional and CLE parameters. CLE results are stratified in order to identify which of the recorded CLE parameters that correlate best with the two other methods, and thus are most suitable for the characterization and activity of Crohn's disease.
Statistical method: To calculate the CLE-finding in relation to respectively, SI and histology we use Spearman correlation analysis. At the inter-and intra-observer study used weighted Kappa.
Patient: A complete sample-size calculation has been made for the inter-and intra-observer study of the individual CLE parameters by 3 observers. For, if possible, to achieve a kappa value of 0.9 with a confidence interval of 0.05, there must be 122 observations. If we succeed in registering SI score, CLE parameters and taking tissue samples for pathology in all the above intestinal segments, there will be 7 observations for each patient who subsequently are assessed in relation to each of the parameters used in the study. If all ileocolonoscopy are completed and all CLE observations are possible to analyze just 18 patients need to be enrolled in the study. It is assumed, however, that there will only be 50% of the expected observations as some CLE observations will be unsatisfactory and some procedures will be interrupted. Thus, 36 patients shall be included in the study to achieve the desired strength, 10 of which are in the control group.
- Conditions
- Crohn Disease
- Being tested
- CLE ileocolonoscopy
- Keywords
- confocal laser endomicroscopy, Crohn´disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLE ileocolonoscopyDevice
Also called confocal laser endomiscoscopy ileocolonoscopy, confocal laser endomiscoscopy colonoscopy
The patients enrolled including the control group, will be investigated respectively, by conventional colonoscopy and CLE in both the terminal ileum as colon. The degree and extent of Crohn's disease are assessed by conventional ileocolonoscopy (SI), CLE (selected parameters) and histology biopsies. Then, the correlation between histology (gold standard), SI and CLE is calculated. An intra-and inter-observer study follows on CLE parameters, where 3 observers are blinded with respect to each other. The pathologist is blinded to conventional and CLE parameters. CLE results are stratified in order to identify which of the recorded CLE parameters that correlate best with the two other methods.
| Study group | Role | What they receive |
|---|---|---|
| CLE ileocolonoscopy on Crohn patients | Active comparator | Patients known with Crohn´s disease Receives: Device: CLE ileocolonoscopy |
| CLE ileocolonoscopy on control patients | Sham comparator | CLE ileocolonoscopy on patients without known IBD Receives: Device: CLE ileocolonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLE (CLE score) vs WL colonoscopy (SES-CD)
Findings in CLE are recorded regarding inflammation (crypt architecture, vessel architecture, barrier dysfunction and inflammatory cell invasion 1-3 points each) and compared with the findings of conventional colonoscopy ted Simple endoscopic score - Crohn´s disease (SES-CD), including observations for the control group
Measured: 1 year
CLE (CLE-score) vs pathology score for inflammation
CLE (crypt architecture, vessel architecture, barrier dysfunction and inflammatory cell invasion 1-3 points each) and colonoscopy findings are compared with the pathological evaluation of the inflammation in the tissue samples (points from 1-3 by the severity).
Measured: 1 year
CLE findings (CLE-score) and Intra-and inter-observer agreement
Intra-and inter-observer agreements between 3 operators at CLE findings are calculated by kappa statistics (crypt architecture, vessel architecture, barrier dysfunction and inflammatory cell invasion).
Measured: 1 year
Secondary outcomes (2)
Registering time of the procedure.
Registering time of the procedure.
Measured: 1 year
Number of Adverse Events
Number of Adverse Events related to the procedure is registered
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Gasdal Karstensen, Herlev Hospital
- Investigators
- john g Karstensen, M.D., Principal investigator, Department of Gastroenterologypeter vilmann, Prof., Study chair, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738529
- Sponsor's protocol ID
- H-1-2012-089 sub 3
- Status last verified
- Feb 2015
- First submitted
- 19 Nov 2012
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kiesslich R, Duckworth CA, Moussata D, Gloeckner A, Lim LG, Goetz M, Pritchard DM, Galle PR, Neurath MF, Watson AJ. Local barrier dysfunction identified by confocal laser endomicroscopy predicts relapse in inflammatory bowel disease. Gut. 2012 Aug;61(8):1146-53. doi: 10.1136/gutjnl-2011-300695. Epub 2011 Nov 24.
PubMed 22115910Liu JJ, Wong K, Thiesen AL, Mah SJ, Dieleman LA, Claggett B, Saltzman JR, Fedorak RN. Increased epithelial gaps in the small intestines of patients with inflammatory bowel disease: density matters. Gastrointest Endosc. 2011 Jun;73(6):1174-80. doi: 10.1016/j.gie.2011.01.018. Epub 2011 Mar 11.
PubMed 21396639Li CQ, Xie XJ, Yu T, Gu XM, Zuo XL, Zhou CJ, Huang WQ, Chen H, Li YQ. Classification of inflammation activity in ulcerative colitis by confocal laser endomicroscopy. Am J Gastroenterol. 2010 Jun;105(6):1391-6. doi: 10.1038/ajg.2009.664. Epub 2009 Nov 24.
PubMed 19935787Vermeire S, Schreiber S, Sandborn WJ, Dubois C, Rutgeerts P. Correlation between the Crohn's disease activity and Harvey-Bradshaw indices in assessing Crohn's disease severity. Clin Gastroenterol Hepatol. 2010 Apr;8(4):357-63. doi: 10.1016/j.cgh.2010.01.001. Epub 2010 Jan 21.
PubMed 20096379Van Assche G, Dignass A, Reinisch W, van der Woude CJ, Sturm A, De Vos M, Guslandi M, Oldenburg B, Dotan I, Marteau P, Ardizzone A, Baumgart DC, D'Haens G, Gionchetti P, Portela F, Vucelic B, Soderholm J, Escher J, Koletzko S, Kolho KL, Lukas M, Mottet C, Tilg H, Vermeire S, Carbonnel F, Cole A, Novacek G, Reinshagen M, Tsianos E, Herrlinger K, Oldenburg B, Bouhnik Y, Kiesslich R, Stange E, Travis S, Lindsay J; European Crohn's and Colitis Organisation (ECCO). The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Special situations. J Crohns Colitis. 2010 Feb;4(1):63-101. doi: 10.1016/j.crohns.2009.09.009. Epub 2009 Dec 21. No abstract available.
PubMed 21122490Karstensen JG, Saftoiu A, Brynskov J, Hendel J, Klausen P, Cartana T, Klausen TW, Riis LB, Vilmann P. Confocal laser endomicroscopy: a novel method for prediction of relapse in Crohn's disease. Endoscopy. 2016 Apr;48(4):364-72. doi: 10.1055/s-0034-1393314. Epub 2015 Nov 19.
PubMed 26583952
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Crohn's Disease at Confocal Laser Endomicroscopy and Related to Disease Activity
- ClinicalTrials.gov ID
- NCT01738529
- Acronym / sponsor ID
- H-1-2012-089 sub 3
- Conditions
- Crohn Disease
- Keywords
- confocal laser endomicroscopy, Crohn´disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Nov 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.
A blinded prospective observation and methodology study with Confocal Laser Endomicroscopy (CLE) together with standard white light colonoscopy including inter- and intra-observation of patients with Crohn's disease.
Detailed description
Introduction: Crohn's disease is a well-characterized disease, and treatment is carried out according to international guidelines. Despite this, the disease often show an individual, unpredictable course, and more than half of patients experience significant complications of the disease. Endoscopy is important for the assessment of disease dissemination and severity of Crohn's disease, which is complemented by biochemical and clinical indices, including CDAI or Simple Index (SI) (Harwey-Bradshaw), which is internationally recognized. By CDAI, there is shown a good correlation with the biochemical activity markers such as CRP, and serum albumin, and in practice the simplified version (SI). Is often used.
Knowledge about the use of CLE in Crohn's disease is very low. We will on the basis of parameters suggested in smaller studies and our personal CLE experience determine which parameters are useful for a precise estimation of the severity of Crohn's disease. Since the disease is most commonly seen in the terminal ileum, the parameters should apply to both the ileum and colon.
A group Crohn patients have long been in prolonged biochemical and conventional endoscopic remission, including patients treated with the biologic drug infliximab. These patients are also included in the study as a particularly interesting subgroup as CLE in a small study has suggested to contribute to the safe discontinuation of immunosuppressive therapy. The degree of healing of the mucous membrane including an intact barrier function is one of the most important prognostic factors for patients to develop a recurrence. Thus it will be of great clinical importance to clarify whether CLE can help to distinguish those patients who have an apparently normal endoscopy, yet unrealized discrete activity and defective barrier function from patients where there is no activity evaluated endoscopically and by CLE. Furthermore, a small number of patients will be included as a control group.
Hypothesis: CLE can characterize Crohn's disease and activity precisely in the ileum and colon compared with conventional ileocolonoscopy, including detecting slight degrees and wider dissemination of inflammation that would otherwise not be recognized.
Design: A blinded prospective observation and method study of patients with subsequent calculation of intra-and inter-observer variability.
Method: The patients enrolled including the control group, will be investigated respectively, by conventional colonoscopy and CLE in both the terminal ileum as colon. The degree and extent of Crohn's disease are assessed by conventional ileocolonoscopy (SI), CLE (selected parameters) and histology biopsies. Terminal ileum and each colonic segment (caecum, ascending colon, transversal colon, descending colon, colon sigmoid and rectum) are assessed as described above. Then, the correlation between histology (gold standard), SI and CLE is calculated. An intra-and inter-observer study follows on CLE parameters, where 3 observers are blinded with respect to each other. The pathologist is blinded to conventional and CLE parameters. CLE results are stratified in order to identify which of the recorded CLE parameters that correlate best with the two other methods, and thus are most suitable for the characterization and activity of Crohn's disease.
Statistical method: To calculate the CLE-finding in relation to respectively, SI and histology we use Spearman correlation analysis. At the inter-and intra-observer study used weighted Kappa.
Patient: A complete sample-size calculation has been made for the inter-and intra-observer study of the individual CLE parameters by 3 observers. For, if possible, to achieve a kappa value of 0.9 with a confidence interval of 0.05, there must be 122 observations. If we succeed in registering SI score, CLE parameters and taking tissue samples for pathology in all the above intestinal segments, there will be 7 observations for each patient who subsequently are assessed in relation to each of the parameters used in the study. If all ileocolonoscopy are completed and all CLE observations are possible to analyze just 18 patients need to be enrolled in the study. It is assumed, however, that there will only be 50% of the expected observations as some CLE observations will be unsatisfactory and some procedures will be interrupted. Thus, 36 patients shall be included in the study to achieve the desired strength, 10 of which are in the control group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLE ileocolonoscopy on Crohn patients | Active comparator | Device: CLE ileocolonoscopyPatients known with Crohn´s disease |
| CLE ileocolonoscopy on control patients | Sham comparator | Device: CLE ileocolonoscopyCLE ileocolonoscopy on patients without known IBD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Crohn's disease and involvement of the ileum and / or colon
- Patients must be of legal age
- Shall be given written consent
- Both patients with the activity of their disease patients in remission on biological treatment including can be included
- The control group will consist of patients without known or suspected IBD
Key exclusion criteria (4 listed)
- Increased p-creatinine
- Demonstrated allergy to fluorescein
- Pregnant woman
- Lactating woman
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 |
|---|---|---|
| CLE ileocolonoscopyAlso: confocal laser endomiscoscopy ileocolonoscopy, confocal laser endomiscoscopy colonoscopyThe patients enrolled including the control group, will be investigated respectively, by conventional colonoscopy and CLE in both the terminal ileum as colon. The degree and extent of Crohn's disease are assessed by conventional ileocolonoscopy (SI), CLE (selected parameters) and histology biopsies. Then, the correlation between histology (gold standard), SI and CLE is calculated. An intra-and inter-observer study follows on CLE parameters, where 3 observers are blinded with respect to each other. The pathologist is blinded to conventional and CLE parameters. CLE results are stratified in order to identify which of the recorded CLE parameters that correlate best with the two other methods. | Device | CLE ileocolonoscopy on Crohn patients, CLE ileocolonoscopy on control patients |
Primary outcome
CLE (CLE score) vs WL colonoscopy (SES-CD)
Time frame: 1 year
Findings in CLE are recorded regarding inflammation (crypt architecture, vessel architecture, barrier dysfunction and inflammatory cell invasion 1-3 points each) and compared with the findings of conventional colonoscopy ted Simple endoscopic score - Crohn´s disease (SES-CD), including observations for the control group
CLE (CLE-score) vs pathology score for inflammation
Time frame: 1 year
CLE (crypt architecture, vessel architecture, barrier dysfunction and inflammatory cell invasion 1-3 points each) and colonoscopy findings are compared with the pathological evaluation of the inflammation in the tissue samples (points from 1-3 by the severity).
CLE findings (CLE-score) and Intra-and inter-observer agreement
Time frame: 1 year
Intra-and inter-observer agreements between 3 operators at CLE findings are calculated by kappa statistics (crypt architecture, vessel architecture, barrier dysfunction and inflammatory cell invasion).
2 secondary outcomes
Registering time of the procedure.
Time frame: 1 year
Number of Adverse Events
Time frame: 1 year
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 18 Feb 2015.
- Background: PubMed 22115910Kiesslich R, Duckworth CA, Moussata D, Gloeckner A, Lim LG, Goetz M, Pritchard DM, Galle PR, Neurath MF, Watson AJ. Local barrier dysfunction identified by confocal laser endomicroscopy predicts relapse in inflammatory bowel disease. Gut. 2012 Aug;61(8):1146-53. doi: 10.1136/gutjnl-2011-300695. Epub 2011 Nov 24.
- Background: PubMed 21396639Liu JJ, Wong K, Thiesen AL, Mah SJ, Dieleman LA, Claggett B, Saltzman JR, Fedorak RN. Increased epithelial gaps in the small intestines of patients with inflammatory bowel disease: density matters. Gastrointest Endosc. 2011 Jun;73(6):1174-80. doi: 10.1016/j.gie.2011.01.018. Epub 2011 Mar 11.
- Background: PubMed 19935787Li CQ, Xie XJ, Yu T, Gu XM, Zuo XL, Zhou CJ, Huang WQ, Chen H, Li YQ. Classification of inflammation activity in ulcerative colitis by confocal laser endomicroscopy. Am J Gastroenterol. 2010 Jun;105(6):1391-6. doi: 10.1038/ajg.2009.664. Epub 2009 Nov 24.
- Background: PubMed 20096379Vermeire S, Schreiber S, Sandborn WJ, Dubois C, Rutgeerts P. Correlation between the Crohn's disease activity and Harvey-Bradshaw indices in assessing Crohn's disease severity. Clin Gastroenterol Hepatol. 2010 Apr;8(4):357-63. doi: 10.1016/j.cgh.2010.01.001. Epub 2010 Jan 21.
- Background: PubMed 21122490Van Assche G, Dignass A, Reinisch W, van der Woude CJ, Sturm A, De Vos M, Guslandi M, Oldenburg B, Dotan I, Marteau P, Ardizzone A, Baumgart DC, D'Haens G, Gionchetti P, Portela F, Vucelic B, Soderholm J, Escher J, Koletzko S, Kolho KL, Lukas M, Mottet C, Tilg H, Vermeire S, Carbonnel F, Cole A, Novacek G, Reinshagen M, Tsianos E, Herrlinger K, Oldenburg B, Bouhnik Y, Kiesslich R, Stange E, Travis S, Lindsay J; European Crohn's and Colitis Organisation (ECCO). The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Special situations. J Crohns Colitis. 2010 Feb;4(1):63-101. doi: 10.1016/j.crohns.2009.09.009. Epub 2009 Dec 21. No abstract available.
- Derived from this study: PubMed 26583952Karstensen JG, Saftoiu A, Brynskov J, Hendel J, Klausen P, Cartana T, Klausen TW, Riis LB, Vilmann P. Confocal laser endomicroscopy: a novel method for prediction of relapse in Crohn's disease. Endoscopy. 2016 Apr;48(4):364-72. doi: 10.1055/s-0034-1393314. Epub 2015 Nov 19.
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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.
john g Karstensen, M.D. principal investigator
Department of Gastroenterology
peter vilmann, Prof. study chair
Department of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLE ileocolonoscopy in people with Crohn Disease, run by Herlev Hospital at 1 site in Denmark.
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 5 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 18 Feb 2015. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
CLE (CLE score) vs WL colonoscopy (SES-CD) (time frame: 1 year). The study lists 3 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 NCT01738529, which also lists 6 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 18 Feb 2015.