xml: <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/NCT05980455</url>
    </required_header>
    <id_info>
      <org_study_id>CLN 001-PR-00755</org_study_id>
      <nct_id>NCT05980455</nct_id>
    </id_info>
    <brief_title>Study of Enterra Programming With Nocturnal Cycling in Gastroparetics</brief_title>
    <acronym>RESTING</acronym>
    <official_title>Randomized Study of Enterra Programming With Nocturnal Cycling in Gastroparetics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Enterra Medical, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Enterra Medical, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research study is to evaluate if different Enterra™ device programming&#xD;
        methods active during sleeping hours can maintain gastroparesis-related symptom relief and&#xD;
        quality of life measures.&#xD;
  &#xD;
        Participants in this study with existing Enterra™ devices will be randomly assigned to one of&#xD;
        three programming methods that will be active during sleep. Participants will answer daily&#xD;
        questions about their gastroparesis symptoms on an application with their phone/tablet.&#xD;
        Participants will answer quality of life questionnaires about their gastroparesis symptoms at&#xD;
        study visits.&#xD;
  &#xD;
        Participants will be involved in the study for up to six months after treatment assignment.&#xD;
  &#xD;
        Programming parameters in the study are within currently approved labeling.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percent Change in Weekly Vomiting Frequency by GCSI-DD</measure>
      <time_frame>3 Months, 6 Months</time_frame>
      <description>Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Scoring Change in Nausea Severity by GCSI-DD</measure>
      <time_frame>3 Months, 6 Months</time_frame>
      <description>Less than a 1-point increase in GCSI-DD nausea severity from baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean Change from Baseline in GCSI-DD Total Symptom Score</measure>
      <time_frame>3 Months, 6 Months</time_frame>
      <description>Change in GCSI-DD Total Symptom Score from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Change from Baseline in GCSI-DD Nausea Severity</measure>
      <time_frame>3 Months, 6 Months</time_frame>
      <description>Change in GCSI-DD nausea severity from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency</measure>
      <time_frame>3 Months, 6 Months</time_frame>
      <description>Change in GCSI-DD weekly vomiting frequency from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Change from Baseline in PAGI-QoL Scores</measure>
      <time_frame>3 Months, 6 Months</time_frame>
      <description>Change in PAGI-QoL from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Change from Baseline in Quality of Sleep Scores</measure>
      <time_frame>3 Months, 6 Months</time_frame>
      <description>Change in Quality of Sleep from baseline</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Gastroparesis</condition>
    <condition>Gastroparesis Nondiabetic</condition>
    <condition>Gastroparesis Due to Diabetes Mellitus</condition>
    <arm_group>
      <arm_group_label>Control Sleep Cycle</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Baseline device programming parameters will be used during study participation. No modification to Enterra™ device programming will be in effect during waking or sleeping hours.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 1 Sleep Cycle</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Device programming parameters participants have at enrollment will be used during waking hours.&#xD;
  During sleeping hours, the Enterra™ device will cycle through modified programming over the course of 6 hours. Each hour, the Enterra™ device will deliver 30 minutes of reduced stimulation, followed by 30 minutes of waking hours stimulation. At the end of the 6-hour sleep cycle, the Enterra™ device will return to waking hours programming.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2 Sleep Cycle</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Device programming parameters participants have at enrollment will be used during waking hours.&#xD;
  During sleeping hours, the Enterra™ device will cycle through modified programming over the course of 8 hours. Each hour, the Enterra™ device will deliver 45 minutes of reduced stimulation, followed by 15 minutes of waking hours stimulation. At the end of the 8-hour sleep cycle, the Enterra™ device will return to waking hours programming.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Enterra™ Therapy System</intervention_name>
      <description>The Enterra™ Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.</description>
      <arm_group_label>Arm 1 Sleep Cycle</arm_group_label>
      <arm_group_label>Arm 2 Sleep Cycle</arm_group_label>
      <arm_group_label>Control Sleep Cycle</arm_group_label>
      <other_name>Gastric electrical stimulation</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          In order to be eligible to participate in this study, a participant must meet all of the&#xD;
          following criteria:&#xD;
  &#xD;
            1. Completed informed consent process with signed and dated informed consent form;&#xD;
  &#xD;
            2. Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study;&#xD;
  &#xD;
            3. Male or female, aged ≥18 or ≤70 at time of informed consent;&#xD;
  &#xD;
            4. Currently implanted with the Enterra™ Therapy System (Enterra™ II 37800&#xD;
               neurostimulator);&#xD;
  &#xD;
            5. High GES output defined as remaining pulse generator expected life of &gt; 9 months from&#xD;
               enrollment and less than 4 years from the time of implant;&#xD;
  &#xD;
            6. Stable gastroparesis symptoms, in the opinion of the investigator;&#xD;
  &#xD;
            7. On stable medical therapy for gastroparesis symptoms;&#xD;
  &#xD;
            8. On stable supplemental nutritional support during the month prior to enrollment.&#xD;
  &#xD;
          A participant who meets any of the following criteria will be excluded from participation&#xD;
          in this study:&#xD;
  &#xD;
            1. Post-surgical gastroparesis (e.g., fundoplication, Bilroth I or II) or other active&#xD;
               stomach or gastrointestinal diseases disorders which could explain symptoms in the&#xD;
               opinion of the investigator;&#xD;
  &#xD;
            2. Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at&#xD;
               night;&#xD;
  &#xD;
            3. Subjects, in the opinion of the investigator, with profound gastroparesis symptoms&#xD;
               upon waking in the morning;&#xD;
  &#xD;
            4. Subjects without a regular and defined sleep schedule;&#xD;
  &#xD;
            5. Pregnancy, or subject that intends to become pregnant during participation in the&#xD;
               study;&#xD;
  &#xD;
            6. Chemical dependency;&#xD;
  &#xD;
            7. Enterra lead impedance measurements ≥ 700 Ohms at screening visit;&#xD;
  &#xD;
            8. Life expectancy &lt; 1 year from conditions other than GI diseases;&#xD;
  &#xD;
            9. Subjects with an underlying disease leading to follow-up by MRI;&#xD;
  &#xD;
           10. Participation in other clinical studies;&#xD;
  &#xD;
           11. Subjects involved in current or past medical-related litigation;&#xD;
  &#xD;
           12. Subjects with cognitive impairment or other characteristic that would limit subject's&#xD;
               ability to complete study requirements.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Abigail Stocker, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Louisville</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Timothy McAllister</last_name>
      <phone>855-768-3772</phone>
      <email>clinicalresearch@enterramedical.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jason Hamann, PhD</last_name>
      <phone>855-768-3772</phone>
      <email>clinicalresearch@enterramedical.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Louisville</name>
        <address>
          <city>Louisville</city>
          <state>Kentucky</state>
          <zip>40202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abigail Stocker, MD</last_name>
        <phone>502-588-4600</phone>
        <email>abigail.stocker@louisville.edu</email>
      </contact>
      <investigator>
        <last_name>Abigail Stocker, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Gastric electrical stimulation</keyword>
    <keyword>Gastroparesis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroparesis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980455
  org study id: CLN 001-PR-00755
  nct id: NCT05980455
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this research study is to evaluate if different Enterra™ device programming
        methods active during sleeping hours can maintain gastroparesis-related symptom relief and
        quality of life measures.
  
        Participants in this study with existing Enterra™ devices will be randomly assigned to one of
        three programming methods that will be active during sleep. Participants will answer daily
        questions about their gastroparesis symptoms on an application with their phone/tablet.
        Participants will answer quality of life questionnaires about their gastroparesis symptoms at
        study visits.
  
        Participants will be involved in the study for up to six months after treatment assignment.
  
        Programming parameters in the study are within currently approved labeling.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Percent Change in Weekly Vomiting Frequency by GCSI-DD
  time frame: 3 Months, 6 Months
  description: Less than a 50% increase in GCSI-DD weekly vomiting frequency from baseline
  measure: Scoring Change in Nausea Severity by GCSI-DD
  time frame: 3 Months, 6 Months
  description: Less than a 1-point increase in GCSI-DD nausea severity from baseline
  measure: Mean Change from Baseline in GCSI-DD Total Symptom Score
  time frame: 3 Months, 6 Months
  description: Change in GCSI-DD Total Symptom Score from baseline
  measure: Mean Change from Baseline in GCSI-DD Nausea Severity
  time frame: 3 Months, 6 Months
  description: Change in GCSI-DD nausea severity from baseline
  measure: Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency
  time frame: 3 Months, 6 Months
  description: Change in GCSI-DD weekly vomiting frequency from baseline
  measure: Mean Change from Baseline in PAGI-QoL Scores
  time frame: 3 Months, 6 Months
  description: Change in PAGI-QoL from baseline
  measure: Mean Change from Baseline in Quality of Sleep Scores
  time frame: 3 Months, 6 Months
  description: Change in Quality of Sleep from baseline
  arm group label: Control Sleep Cycle
  arm group type: Active Comparator
  description: Baseline device programming parameters will be used during study participation. No modification to Enterra™ device programming will be in effect during waking or sleeping hours.
  arm group label: Arm 1 Sleep Cycle
  arm group type: Experimental
  description: Device programming parameters participants have at enrollment will be used during waking hours.
  During sleeping hours, the Enterra™ device will cycle through modified programming over the course of 6 hours. Each hour, the Enterra™ device will deliver 30 minutes of reduced stimulation, followed by 30 minutes of waking hours stimulation. At the end of the 6-hour sleep cycle, the Enterra™ device will return to waking hours programming.
  arm group label: Arm 2 Sleep Cycle
  arm group type: Experimental
  description: Device programming parameters participants have at enrollment will be used during waking hours.
  During sleeping hours, the Enterra™ device will cycle through modified programming over the course of 8 hours. Each hour, the Enterra™ device will deliver 45 minutes of reduced stimulation, followed by 15 minutes of waking hours stimulation. At the end of the 8-hour sleep cycle, the Enterra™ device will return to waking hours programming.
  intervention type: Device
  intervention name: Enterra™ Therapy System
  description: The Enterra™ Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.
  arm group label: Arm 1 Sleep Cycle
  arm group label: Arm 2 Sleep Cycle
  arm group label: Control Sleep Cycle
  other name: Gastric electrical stimulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Abigail Stocker, MD
  role: Principal Investigator
  affiliation: University of Louisville
  last name: Timothy McAllister
  phone: 855-768-3772
  email: clinicalresearch@enterramedical.com
  last name: Jason Hamann, PhD
  phone: 855-768-3772
  email: clinicalresearch@enterramedical.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Gastroparesis