<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/NCT03031301</url>
  </required_header>
  <id_info>
    <org_study_id>240CLD</org_study_id>
    <nct_id>NCT03031301</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week</brief_title>
  <official_title>A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vibrant Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vibrant Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled&#xD;
      study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation&#xD;
      in subjects with functional constipation.&#xD;
&#xD;
      Two arms will be assessed:&#xD;
&#xD;
        -  Vibrant Capsule administered 5 times per week&#xD;
&#xD;
        -  Sham Capsule administered 5 times per week&#xD;
&#xD;
      Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a&#xD;
      treatment period of 8 weeks.&#xD;
&#xD;
      Data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary.&#xD;
&#xD;
      Subjects will be asked to refrain from taking any medication or supplement to relieve their&#xD;
      constipation, during the entire study period.&#xD;
&#xD;
      After the 14 days of run-in period, the subjects will return and eligibility will be&#xD;
      re-assessed. Subjects will be trained on how to use the base unit and will swallow the first&#xD;
      capsule on site the day of baseline visit. They will activate and ingest the rest of the&#xD;
      capsules at home by themselves, using the base unit.&#xD;
&#xD;
      Subjects will be instructed to complete a simple subject eDiary each day throughout the&#xD;
      duration of the study. A final visit will take place at the end of the 8 week treatment&#xD;
      period.&#xD;
&#xD;
      Subjects will receive phone calls at least once a week and subject compliance will be&#xD;
      monitored during the 8 weeks of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Spontaneous Bowel Movement (CSBM) success rate, defined as an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.</measure>
    <time_frame>8 weeks</time_frame>
    <description>Complete Spontaneous Bowel Movements</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Vibrant capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive the Vibrant capsule 5 times a week for 8 weeks of treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham capsule</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will receive the sham capsule (activated, non-vibrating) 5 times a week for 8 weeks of treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vibrant capsule</intervention_name>
    <description>One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.</description>
    <arm_group_label>Vibrant capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham capsule</intervention_name>
    <description>One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.</description>
    <arm_group_label>Sham capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects aged 22 years and older&#xD;
&#xD;
          2. Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteria and&#xD;
             who have not experienced relief of their symptoms from available therapies&#xD;
&#xD;
          3. Subjects with an average of &lt;3 Spontaneous Bowel Movements (SBM) per week and ≥1 SBM&#xD;
             per week&#xD;
&#xD;
          4. Normal colonoscopy performed within 10 years prior to study participation, unless the&#xD;
             subjects are &lt;50 years old and without alarm signs and/or symptoms&#xD;
&#xD;
          5. Subject signed the Informed Consent Form (ICF)&#xD;
&#xD;
          6. Female subjects must have a negative pregnancy test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of complicated/obstructive diverticular disease&#xD;
&#xD;
          2. History of intestinal or colonic obstruction, or suspected intestinal obstruction.&#xD;
&#xD;
          3. History of significant gastrointestinal disorder, including any form of inflammatory&#xD;
             bowel disease or gastrointestinal malignancy (celiac disease is accepted if the&#xD;
             subject has been treated and is in remission)&#xD;
&#xD;
          4. History of gastroparesis&#xD;
&#xD;
          5. Use of any of the following medications:&#xD;
&#xD;
               -  Medications that may affect intestinal motility, prokinetics, anti-depressants,&#xD;
                  anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers,&#xD;
                  aluminum/magnesium hydroxide&#xD;
&#xD;
               -  With the exception of antidepressants, thyroid or hormonal replacement therapy,&#xD;
                  when the subject has been on a stable dose for at least 3 months prior to&#xD;
                  enrollment.&#xD;
&#xD;
          6. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary,&#xD;
             endocrine, psychiatric or neurologic disease.&#xD;
&#xD;
          7. Presence of cardiac pacemaker or gastric electrical stimulator.&#xD;
&#xD;
          8. History of, or current eating disorders, such as anorexia, bulimia, or compulsory&#xD;
             overeating.&#xD;
&#xD;
          9. Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically&#xD;
             significant rectocele, history of intestinal resection (with an exception for&#xD;
             appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric&#xD;
             surgery or evidence of any structural abnormality of the gastrointestinal tract that&#xD;
             might affect transit&#xD;
&#xD;
         10. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture&#xD;
             or achalasia&#xD;
&#xD;
         11. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)&#xD;
&#xD;
         12. Subjects with pelvic floor dysfunction/defecatory disorder&#xD;
&#xD;
         13. Participation in another clinical study within one month prior to screening.&#xD;
&#xD;
         14. Women who are pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dvora Darky</last_name>
    <phone>+972-4-6660885</phone>
    <email>dvora.d@vibrantgastro.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lior Ben Tsur</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Avant Guntersville</name>
      <address>
        <city>Guntersville</city>
        <state>Alabama</state>
        <zip>35976</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cynthia Abath</last_name>
    </contact>
    <investigator>
      <last_name>William A Nixon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Floridian Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33145</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Milene Garcia</last_name>
    </contact>
    <investigator>
      <last_name>Jorge Loredo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 11, 2018</last_update_submitted>
  <last_update_submitted_qc>January 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</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/NCT03031301
org study id: 240CLD
nct id: NCT03031301
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled
      study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation
      in subjects with functional constipation.

      Two arms will be assessed:

        -  Vibrant Capsule administered 5 times per week

        -  Sham Capsule administered 5 times per week

      Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a
      treatment period of 8 weeks.

      Data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary.

      Subjects will be asked to refrain from taking any medication or supplement to relieve their
      constipation, during the entire study period.

      After the 14 days of run-in period, the subjects will return and eligibility will be
      re-assessed. Subjects will be trained on how to use the base unit and will swallow the first
      capsule on site the day of baseline visit. They will activate and ingest the rest of the
      capsules at home by themselves, using the base unit.

      Subjects will be instructed to complete a simple subject eDiary each day throughout the
      duration of the study. A final visit will take place at the end of the 8 week treatment
      period.

      Subjects will receive phone calls at least once a week and subject compliance will be
      monitored during the 8 weeks of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Complete Spontaneous Bowel Movement (CSBM) success rate, defined as an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.
time frame: 8 weeks
description: Complete Spontaneous Bowel Movements
arm group label: Vibrant capsule
arm group type: Active Comparator
description: Patients will receive the Vibrant capsule 5 times a week for 8 weeks of treatment
arm group label: Sham capsule
arm group type: Sham Comparator
description: Patients will receive the sham capsule (activated, non-vibrating) 5 times a week for 8 weeks of treatment
intervention type: Device
intervention name: Vibrant capsule
description: One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.
arm group label: Vibrant capsule
intervention type: Device
intervention name: Sham capsule
description: One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.
arm group label: Sham capsule
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Dvora Darky
phone: +972-4-6660885
email: dvora.d@vibrantgastro.com
last name: Lior Ben Tsur
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Constipation
sharing ipd: Undecided