<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04456400</url>
  </required_header>
  <id_info>
    <org_study_id>cMSOT-2</org_study_id>
    <nct_id>NCT04456400</nct_id>
  </id_info>
  <brief_title>Enhancing Ultrasound &amp; Photoacoustic for Recognition of Intestinal Abnormalities</brief_title>
  <acronym>EUPHORIA</acronym>
  <official_title>Enhancing Ultrasound &amp; Photoacoustic for Recognition of Intestinal Abnormalities (EUPHORIA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>iThera Medical GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>iThera Medical GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical investigation aims to generate clinical data to support the use of Multispectral&#xD;
      Optoacoustic Tomography (MSOT) in clinical practice, its inclusion in diagnostic guidelines&#xD;
      and to support its reimbursement, specifically to&#xD;
&#xD;
        -  Further validate the application with respect to including ulcerative colitis patients&#xD;
&#xD;
        -  Prepare a study protocol for large-scale clinical validation study in inflammatory bowel&#xD;
           disease (IBD)&#xD;
&#xD;
        -  Successfully execute the clinical validation study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical investigation, EUPHORIA, will pave the way to establish Multispectral&#xD;
      Optoacoustic Tomography (MSOT) technology for the non-invasive assessment of intestinal&#xD;
      inflammation in patients. EUPHORIA will enable commercialization of the technology by&#xD;
      finalizing technical improvements that will increase diagnostic outcome beyond what has been&#xD;
      shown in a first feasibility study, will improve usability, prepare CE marking for the new&#xD;
      device and validate clinical results in a large clinical investigation.&#xD;
&#xD;
      Inflammatory bowel disease (IBD) is a chronic condition, posing significant burden to&#xD;
      patients and health care systems. Patients suffer from a relapsing course of intestinal&#xD;
      inflammation, and to date, there is no satisfying noninvasive diagnostic modality for&#xD;
      monitoring disease activity. In a recent clinical study conducted by University Hospital&#xD;
      Erlangen, MSOT, a technology developed by iThera Medical (ITM), has proven to be superior in&#xD;
      diagnostic performance to other procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Interim Analysis in progress.&#xD;
  </why_stopped>
  <start_date type="Actual">February 3, 2021</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Derivation Cohort: derive optimum diagnostic MSOT thresholds</measure>
    <time_frame>5-10 days</time_frame>
    <description>Derivation cohort: The primary endpoint of the derivation cohort is to derive optimum diagnostic MSOT thresholds based on receiver operating characteristics (ROC) analysis to distinguish endoscopic active disease from remission in Crohn's Disease (CD) or Ulcerative Colitis (UC) patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validation cohort: re-assess the diagnostic accuracy of MSOT</measure>
    <time_frame>5-10 days</time_frame>
    <description>Validation cohort:&#xD;
The primary endpoint of the validation cohort is to re-assess the diagnostic accuracy of MSOT to distinguish endoscopic active disease from remission in an independent cohort. It will be considered successful if a lower 90% confidence of limit at least 75% of area under curve (AUC) is reached</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Derivation Cohort: MSOT thresholds</measure>
    <time_frame>9-10 months</time_frame>
    <description>Derive MSOT thresholds using histology as a reference: receiver operating characteristics (ROC) analysis to distinguish histologic active disease from remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derivation Cohort: MSOT performance, diagnostic accuracy measures</measure>
    <time_frame>9-10 months</time_frame>
    <description>Diagnostic accuracy measures (area under curve (AUC), sensitivity, specificity) of MSOT to distinguish endoscopic active disease from remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derivation Cohort: MSOT performance, diagnostic accuracy</measure>
    <time_frame>9-10 months</time_frame>
    <description>Diagnostic accuracy of MSOT to distinguish histologic active disease from remission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validation Cohort: MSOT performance, diagnostic accuracy measures</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Further diagnostic accuracy measures (sensitivity, specificity, predictive values) of MSOT to distinguish endoscopic active disease from remission using the MSOT thresholds from the derivation cohort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validation Cohort: MSOT performance, diagnostic accuracy</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Diagnostic accuracy (area under curve (AUC), sensitivity, specificity, predictive values) of MSOT to distinguish histologic active disease from remission using the MSOT thresholds from the derivation cohort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Both cohorts: diagnostic accuracy</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Diagnostic accuracy of MSOT to distinguish clinical active disease from remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Both cohorts: performance of other non-invasive diagnostic modalities</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Assess performance of other non-invasive diagnostic modalities in order to allow for comparison to MSOT performance. Diagnostic accuracy of each of the various non-invasive tests (CRP, fCal, US, MRI) with respect to the endoscopy (reference test) and histology will be calculated using standard techniques for diagnostic studies. This includes cross tabulation of the index test results by the results of the reference standard, as well as plots of their distribution and ROC curves. Area under the Curve (AUC) estimates and conﬁdence intervals (DeLong) will be calculated. Score conﬁdence intervals (Wilson) will be calculated for proportions such as sensitivity, speciﬁcity, and predictive values at the predeﬁned thresholds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Both cohorts: likelihood ratios and predictive values for active inflammation</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Assess the likelihood ratios and predictive values for active inflammation after MSOT examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Both cohorts: performance of MSOT in combination with other modalities</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Explore performance of MSOT in combination with other modalities, e.g. in combination with ultrasound (US) or laboratory. AUC will be estimated for all non-invasive tests with a 95% conﬁdence interval (DeLong) both from the derivation cohort and from the pooled cohorts (derivation + validation) for increased precision. Cohen's κ will be used as a measure of overall agreement. Results will be presented in three-way tables, comparing the new test (MSOT), the non-reference standard (non-invasive modalities), and the reference standard (endoscopy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Both cohorts: discriminate different grades of disease activity</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Investigate ability of MSOT and other non-invasive diagnostic modalities, i.e. ultrasoiund (US), fecal calprotectin (fCal), clinical scores to discriminate different grades of disease activity (remission, mild, moderate, high according to endoscopy, histology or clinical scores; for cut-offs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Both cohorts: interobserver variability</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Explore variations in MSOT diagnostic accuracy between sites and operators (interobserver variability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Both cohorts: patient preference</measure>
    <time_frame>5-10 days</time_frame>
    <description>Evaluate patient preference for different tests using a patient survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derivation cohort: MSOT thresholds using clinical scores as a reference</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Derive MSOT thresholds using clinical scores as a reference: ROC analysis to distinguish clinical active disease from remission (only derivation cohort).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">540</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Derivation cohort</arm_group_label>
    <description>The derivation sub-cohort will be used to derive optimum reconstruction algorithm parameters of MSOT images.&#xD;
Primary objective of the derivation cohort is to derive Multispectral Optoacoustic Tomography (MSOT) thresholds maximizing receiver operating characteristic (ROC) to distinguish endoscopic remission from active disease.&#xD;
As secondary objective, performance of the Multispectral Optoacoustic Tomography (MSOT) device will be analyzed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Validation cohort</arm_group_label>
    <description>Objective of the validation cohort is to confirm the performance of Multispectral Optoacoustic Tomography (MSOT) using prescribed thresholds from the derivation cohort.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Multispectral Optoacoustic Tomography (MSOT)</intervention_name>
    <description>cMSOT-2 system is indicated for measurement of the Multispectral Optoacoustic Tomography (MSOT) values in the bowel wall of patients with an established diagnosis of inflammatory bowel disease (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC). The MSOT values provided may be used as an aid to the assessment of inflammatory disease activity in the bowel wall.</description>
    <arm_group_label>Derivation cohort</arm_group_label>
    <arm_group_label>Validation cohort</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Endoscopic histology&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with confirmed diagnosis of CD or UC in whom endoscopy is indicated&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Established diagnosis of UC or CD for at least three months prior to enrollment&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. Indication for endoscopy according to institutes routine care&#xD;
&#xD;
          4. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Stoma independent of localization, ileoanal pouch&#xD;
&#xD;
          2. Prior bowel surgery other than ileocecal resection, which potentially affects the&#xD;
             study procedure by fundamentally changing bowel anatomy by removing the ROI (e.g.&#xD;
             (partial) resection of the sigmoid, left sided colon) or repositioning the ROI to an&#xD;
             inaccessible location (e.g. right-sided colectomy with transversostomy)&#xD;
&#xD;
          3. Indeterminate Colitis, irritable bowel syndrome (IBS)&#xD;
&#xD;
          4. Involvement of the upper gastrointestinal (GI) track only&#xD;
&#xD;
          5. Isolated proctitis&#xD;
&#xD;
          6. Complications, such as infectious enteritis, infectious colitis and infectious&#xD;
             enterocolitis, abscess formation, intestinal obstruction, toxic megacolon&#xD;
&#xD;
          7. Tattoo in skin area of interest&#xD;
&#xD;
          8. Skin lesions, scar tissue or skin diseases affecting the area of imaging&#xD;
&#xD;
          9. Highly pigmented skin in the area of imaging (e.g. Fitzpatrick skin type V and VI)&#xD;
&#xD;
         10. The bowel wall is invisible in the Ultrasound image of the MSOT system&#xD;
&#xD;
         11. Medication leading to increased light sensitivity&#xD;
&#xD;
         12. Pregnant and breastfeeding women&#xD;
&#xD;
         13. Mental retardation of the patient with restriction of general judgment and awareness&#xD;
&#xD;
         14. Exclusion due to safety concerns of investigator (subject who has any condition,&#xD;
             including any physical, psychological, or psychiatric condition, which in the opinion&#xD;
             of the Investigator, would compromise the safety of the subject or the quality of the&#xD;
             data and renders the subject an unsuitable candidate for the study)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maximilian Waldner, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Erlangen Medizinische Klinik 1</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité- Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Hindenburgdamm 30</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen Medizinische Klinik 1</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Tor Vergata</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro per la Ricerca e la Cura delle Malattie Infiammatorie Croniche Intestinali IRCCS Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>Lombardia</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>I.R.C.C.S.San Raffaele, Gastroenterology and Gastrointestinal Endoscopy, Via Olgettina 60</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IBD</keyword>
  <keyword>UC</keyword>
  <keyword>CD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04456400
org study id: cMSOT-2
nct id: NCT04456400
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The clinical investigation aims to generate clinical data to support the use of Multispectral
      Optoacoustic Tomography (MSOT) in clinical practice, its inclusion in diagnostic guidelines
      and to support its reimbursement, specifically to

        -  Further validate the application with respect to including ulcerative colitis patients

        -  Prepare a study protocol for large-scale clinical validation study in inflammatory bowel
           disease (IBD)

        -  Successfully execute the clinical validation study
The clinical investigation, EUPHORIA, will pave the way to establish Multispectral
      Optoacoustic Tomography (MSOT) technology for the non-invasive assessment of intestinal
      inflammation in patients. EUPHORIA will enable commercialization of the technology by
      finalizing technical improvements that will increase diagnostic outcome beyond what has been
      shown in a first feasibility study, will improve usability, prepare CE marking for the new
      device and validate clinical results in a large clinical investigation.

      Inflammatory bowel disease (IBD) is a chronic condition, posing significant burden to
      patients and health care systems. Patients suffer from a relapsing course of intestinal
      inflammation, and to date, there is no satisfying noninvasive diagnostic modality for
      monitoring disease activity. In a recent clinical study conducted by University Hospital
      Erlangen, MSOT, a technology developed by iThera Medical (ITM), has proven to be superior in
      diagnostic performance to other procedures.
observational model: Cohort
time perspective: Cross-Sectional
measure: Derivation Cohort: derive optimum diagnostic MSOT thresholds
time frame: 5-10 days
description: Derivation cohort: The primary endpoint of the derivation cohort is to derive optimum diagnostic MSOT thresholds based on receiver operating characteristics (ROC) analysis to distinguish endoscopic active disease from remission in Crohn's Disease (CD) or Ulcerative Colitis (UC) patients.
measure: Validation cohort: re-assess the diagnostic accuracy of MSOT
time frame: 5-10 days
description: Validation cohort:
The primary endpoint of the validation cohort is to re-assess the diagnostic accuracy of MSOT to distinguish endoscopic active disease from remission in an independent cohort. It will be considered successful if a lower 90% confidence of limit at least 75% of area under curve (AUC) is reached
measure: Derivation Cohort: MSOT thresholds
time frame: 9-10 months
description: Derive MSOT thresholds using histology as a reference: receiver operating characteristics (ROC) analysis to distinguish histologic active disease from remission.
measure: Derivation Cohort: MSOT performance, diagnostic accuracy measures
time frame: 9-10 months
description: Diagnostic accuracy measures (area under curve (AUC), sensitivity, specificity) of MSOT to distinguish endoscopic active disease from remission.
measure: Derivation Cohort: MSOT performance, diagnostic accuracy
time frame: 9-10 months
description: Diagnostic accuracy of MSOT to distinguish histologic active disease from remission
measure: Validation Cohort: MSOT performance, diagnostic accuracy measures
time frame: through study completion, an average of 1 year
description: Further diagnostic accuracy measures (sensitivity, specificity, predictive values) of MSOT to distinguish endoscopic active disease from remission using the MSOT thresholds from the derivation cohort
measure: Validation Cohort: MSOT performance, diagnostic accuracy
time frame: through study completion, an average of 1 year
description: Diagnostic accuracy (area under curve (AUC), sensitivity, specificity, predictive values) of MSOT to distinguish histologic active disease from remission using the MSOT thresholds from the derivation cohort.
measure: Both cohorts: diagnostic accuracy
time frame: through study completion, an average of 1 year
description: Diagnostic accuracy of MSOT to distinguish clinical active disease from remission.
measure: Both cohorts: performance of other non-invasive diagnostic modalities
time frame: through study completion, an average of 1 year
description: Assess performance of other non-invasive diagnostic modalities in order to allow for comparison to MSOT performance. Diagnostic accuracy of each of the various non-invasive tests (CRP, fCal, US, MRI) with respect to the endoscopy (reference test) and histology will be calculated using standard techniques for diagnostic studies. This includes cross tabulation of the index test results by the results of the reference standard, as well as plots of their distribution and ROC curves. Area under the Curve (AUC) estimates and conﬁdence intervals (DeLong) will be calculated. Score conﬁdence intervals (Wilson) will be calculated for proportions such as sensitivity, speciﬁcity, and predictive values at the predeﬁned thresholds.
measure: Both cohorts: likelihood ratios and predictive values for active inflammation
time frame: through study completion, an average of 1 year
description: Assess the likelihood ratios and predictive values for active inflammation after MSOT examination.
measure: Both cohorts: performance of MSOT in combination with other modalities
time frame: through study completion, an average of 1 year
description: Explore performance of MSOT in combination with other modalities, e.g. in combination with ultrasound (US) or laboratory. AUC will be estimated for all non-invasive tests with a 95% conﬁdence interval (DeLong) both from the derivation cohort and from the pooled cohorts (derivation + validation) for increased precision. Cohen's κ will be used as a measure of overall agreement. Results will be presented in three-way tables, comparing the new test (MSOT), the non-reference standard (non-invasive modalities), and the reference standard (endoscopy).
measure: Both cohorts: discriminate different grades of disease activity
time frame: through study completion, an average of 1 year
description: Investigate ability of MSOT and other non-invasive diagnostic modalities, i.e. ultrasoiund (US), fecal calprotectin (fCal), clinical scores to discriminate different grades of disease activity (remission, mild, moderate, high according to endoscopy, histology or clinical scores; for cut-offs.
measure: Both cohorts: interobserver variability
time frame: through study completion, an average of 1 year
description: Explore variations in MSOT diagnostic accuracy between sites and operators (interobserver variability).
measure: Both cohorts: patient preference
time frame: 5-10 days
description: Evaluate patient preference for different tests using a patient survey
measure: Derivation cohort: MSOT thresholds using clinical scores as a reference
time frame: through study completion, an average of 1 year
description: Derive MSOT thresholds using clinical scores as a reference: ROC analysis to distinguish clinical active disease from remission (only derivation cohort).
arm group label: Derivation cohort
description: The derivation sub-cohort will be used to derive optimum reconstruction algorithm parameters of MSOT images.
Primary objective of the derivation cohort is to derive Multispectral Optoacoustic Tomography (MSOT) thresholds maximizing receiver operating characteristic (ROC) to distinguish endoscopic remission from active disease.
As secondary objective, performance of the Multispectral Optoacoustic Tomography (MSOT) device will be analyzed.
arm group label: Validation cohort
description: Objective of the validation cohort is to confirm the performance of Multispectral Optoacoustic Tomography (MSOT) using prescribed thresholds from the derivation cohort.
intervention type: Diagnostic Test
intervention name: Multispectral Optoacoustic Tomography (MSOT)
description: cMSOT-2 system is indicated for measurement of the Multispectral Optoacoustic Tomography (MSOT) values in the bowel wall of patients with an established diagnosis of inflammatory bowel disease (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC). The MSOT values provided may be used as an aid to the assessment of inflammatory disease activity in the bowel wall.
arm group label: Derivation cohort
arm group label: Validation cohort
Endoscopic histology
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maximilian Waldner, Prof. Dr.
role: Principal Investigator
affiliation: Universitätsklinikum Erlangen Medizinische Klinik 1
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Italy
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Inflammatory Bowel Diseases
sharing ipd: Undecided