<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/NCT01702662</url>
  </required_header>
  <id_info>
    <org_study_id>METC2012_150, ABR: 40642</org_study_id>
    <nct_id>NCT01702662</nct_id>
  </id_info>
  <brief_title>Photopill Treatment in Healthy Volunteers</brief_title>
  <acronym>Photopill</acronym>
  <official_title>The Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Healthy Volunteers, a Phase 1 Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in&#xD;
      chemotherapy/radiotherapy oral mucositis.&#xD;
&#xD;
      Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule&#xD;
      treatment in mice showed a significant beneficial effect on the endoscopic severity of&#xD;
      DSS-induced colitis in mice.&#xD;
&#xD;
      Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill&#xD;
      treatment in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability</measure>
    <time_frame>During Study period: day 0-14</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Ulcerated Mucosa of Colon</condition>
  <arm_group>
    <arm_group_label>Photopill treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Photopill treatment</intervention_name>
    <description>2 courses of 5 Photopill treatments within 14 days. In each treatment, 3cm of rectal tissue will be exposed, 2 minutes per cm, to low level light therapy.</description>
    <arm_group_label>Photopill treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who are generally healthy.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with any known GI related symptoms complaints or GI diseases.&#xD;
&#xD;
          -  Subjects with cancer or other life threatening diseases or conditions.&#xD;
&#xD;
          -  Subjects with cardiovascular or pulmonary diseases.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Subjects who underwent any colon surgery.&#xD;
&#xD;
          -  Morbid Obesity (BMI &gt; 40).&#xD;
&#xD;
          -  Drug abuse or alcoholism.&#xD;
&#xD;
          -  Bed-ridden patient.&#xD;
&#xD;
          -  Any rectal therapy.&#xD;
&#xD;
          -  Participation in current clinical study or clinical study within 30 days prior to the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geert D'Haens, Prof.dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academic Medical Center Amsterdam, department of Gastroenterology</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>December 10, 2012</last_update_submitted>
  <last_update_submitted_qc>December 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Hanke Brandse</investigator_full_name>
    <investigator_title>MD, Phd student, executive investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <!-- 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/NCT01702662
org study id: METC2012_150, ABR: 40642
nct id: NCT01702662
lead sponsor: 
has dmc: No
Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in
      chemotherapy/radiotherapy oral mucositis.

      Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule
      treatment in mice showed a significant beneficial effect on the endoscopic severity of
      DSS-induced colitis in mice.

      Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill
      treatment in healthy volunteers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability
time frame: During Study period: day 0-14
arm group label: Photopill treatment
arm group type: Experimental
description: Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times
intervention type: Device
intervention name: Photopill treatment
description: 2 courses of 5 Photopill treatments within 14 days. In each treatment, 3cm of rectal tissue will be exposed, 2 minutes per cm, to low level light therapy.
arm group label: Photopill treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Geert D'Haens, Prof.dr
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Hanke Brandse
investigator title: MD, Phd student, executive investigator
mesh term: Ulcer