<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/NCT03785795</url>
  </required_header>
  <id_info>
    <org_study_id>SBIR1.01</org_study_id>
    <nct_id>NCT03785795</nct_id>
  </id_info>
  <brief_title>Multichannel EMG Diagnosing True Preterm Labor</brief_title>
  <acronym>PTL</acronym>
  <official_title>Optimizing and Validating an EMG-based Fetal Monitor to Identify True Preterm Labor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PreTeL, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PreTeL, Inc</source>
  <oversight_info>
    <has_dmc>No</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>
      We have designed new electromyography sensors for measuring uterine activity. These sensors&#xD;
      are directional - they preferentially report uterine muscle contractions at specific&#xD;
      locations, called regions. By measuring the synchronization of the regions of the uterus&#xD;
      during contractions we intend to non-invasively determine if any patient is in-labor or&#xD;
      not-in-labor. Accurately diagnosing true preterm labor allows timely intervention to avoid&#xD;
      preterm birth; Accurately diagnosing false preterm labor avoids needlessly treating patients&#xD;
      who would not benefit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The legacy device for assessing uterine contractions is the tocodynamometer (Toco). The Toco&#xD;
      is plunger-driven device that measures the uterine shape change that occurs with a&#xD;
      contraction. Toco only reports the timing of contractions, not the contraction strength, and&#xD;
      cannot distinguish between false and true labor.&#xD;
&#xD;
      Our overarching goal is to validate our method of determining if a patient experiencing&#xD;
      contractions is in true labor or false labor. We will accomplish this by applying new&#xD;
      knowledge to an old technology - uterine EMG.&#xD;
&#xD;
      This trial is based on our advanced understanding of how the uterus generates coordinated&#xD;
      contractions without a pacemaker or dedicated electrical conduction pathways -&#xD;
      mechanotransduction and intrauterine pressure - but also uses bioelectrical signaling for&#xD;
      local tissue recruitment.&#xD;
&#xD;
      The uterus emits bioelectrical signals with each contraction that can be detected by&#xD;
      electromyography (EMG). To observe uterine bioelectrical signals, we created a novel EMG&#xD;
      sensor, we call the &quot;area sensor&quot;. This sensor is directional - capable of preferentially&#xD;
      reporting muscle contractions from immediately below the sensor location.&#xD;
&#xD;
      In this clinical trial we use multiple area sensors placed on the maternal abdomen to&#xD;
      directly observe how well the regional contractions are synchronized. Our hypothesis to be&#xD;
      tested is that highly synchronized contractions predicts true labor, unsynchronized predicts&#xD;
      false labor.&#xD;
&#xD;
      Patients with unclear labor status, or those in early labor will be studied. We will&#xD;
      correlate the results of the synchronization analysis against the patient's progress over the&#xD;
      ensuing 24 hours. These data will validate the ability to identify false and true labor using&#xD;
      multichannel EMG and area sensors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 25, 2018</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">January 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validating prediction of true/false labor status with delivery within 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>The test device predicts delivery. The prediction on each subject will be compared against the observed delivery time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Establishing the range and trend of synchronized sensor readings</measure>
    <time_frame>48 hours</time_frame>
    <description>The fraction of EMG channels active during each contraction, and the running average of the fraction, will be correlated with time to delivery</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Pregnancy Preterm</condition>
  <condition>Labor; Irregular</condition>
  <condition>Preterm Labor</condition>
  <arm_group>
    <arm_group_label>Uncertain diagnosis of true labor</arm_group_label>
    <description>Patients who cannot be accurately classified as experiencing true labor or false labor based on standard clinical assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Uncertain diagnosis of true labor</intervention_name>
    <description>Multichannel EMG of uterine bioelectrical signals will be recorded using area sensors. The output of the synchronization calculations will be correlated with the time to delivery</description>
    <arm_group_label>Uncertain diagnosis of true labor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women with viable pregnancies who are experiencing uterine contractions will be&#xD;
        studied. For each subject, her provider will not be certain if she is in true labor, or is&#xD;
        experiencing false labor contractions. Other than experiencing contractions, subjects will&#xD;
        have uncomplicated pregnancies. She will not have an indication for immediate delivery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  One living fetus&#xD;
&#xD;
          -  Experiencing frequent uterine contractions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cervical dilation &gt; 4 cm&#xD;
&#xD;
          -  Ruptured membranes&#xD;
&#xD;
          -  Maternal or fetal indications for immediate delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Subjects must be pregnant</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roger C Young, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>PreTeL, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Young RC. Mechanotransduction mechanisms for coordinating uterine contractions in human labor. Reproduction. 2016 Aug;152(2):R51-61. doi: 10.1530/REP-16-0156. Epub 2016 May 10.</citation>
    <PMID>27165050</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Preterm labor detection</keyword>
  <keyword>Labor detection</keyword>
  <keyword>False labor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Obstetric Labor, Premature</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Specific patient EMG tracings may be shared based on unique characteristics of pregnancy subsets.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03785795/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03785795
org study id: SBIR1.01
nct id: NCT03785795
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
We have designed new electromyography sensors for measuring uterine activity. These sensors
      are directional - they preferentially report uterine muscle contractions at specific
      locations, called regions. By measuring the synchronization of the regions of the uterus
      during contractions we intend to non-invasively determine if any patient is in-labor or
      not-in-labor. Accurately diagnosing true preterm labor allows timely intervention to avoid
      preterm birth; Accurately diagnosing false preterm labor avoids needlessly treating patients
      who would not benefit.
The legacy device for assessing uterine contractions is the tocodynamometer (Toco). The Toco
      is plunger-driven device that measures the uterine shape change that occurs with a
      contraction. Toco only reports the timing of contractions, not the contraction strength, and
      cannot distinguish between false and true labor.

      Our overarching goal is to validate our method of determining if a patient experiencing
      contractions is in true labor or false labor. We will accomplish this by applying new
      knowledge to an old technology - uterine EMG.

      This trial is based on our advanced understanding of how the uterus generates coordinated
      contractions without a pacemaker or dedicated electrical conduction pathways -
      mechanotransduction and intrauterine pressure - but also uses bioelectrical signaling for
      local tissue recruitment.

      The uterus emits bioelectrical signals with each contraction that can be detected by
      electromyography (EMG). To observe uterine bioelectrical signals, we created a novel EMG
      sensor, we call the "area sensor". This sensor is directional - capable of preferentially
      reporting muscle contractions from immediately below the sensor location.

      In this clinical trial we use multiple area sensors placed on the maternal abdomen to
      directly observe how well the regional contractions are synchronized. Our hypothesis to be
      tested is that highly synchronized contractions predicts true labor, unsynchronized predicts
      false labor.

      Patients with unclear labor status, or those in early labor will be studied. We will
      correlate the results of the synchronization analysis against the patient's progress over the
      ensuing 24 hours. These data will validate the ability to identify false and true labor using
      multichannel EMG and area sensors.
observational model: Case-Only
time perspective: Prospective
measure: Validating prediction of true/false labor status with delivery within 24 hours
time frame: 24 hours
description: The test device predicts delivery. The prediction on each subject will be compared against the observed delivery time.
measure: Establishing the range and trend of synchronized sensor readings
time frame: 48 hours
description: The fraction of EMG channels active during each contraction, and the running average of the fraction, will be correlated with time to delivery
arm group label: Uncertain diagnosis of true labor
description: Patients who cannot be accurately classified as experiencing true labor or false labor based on standard clinical assessments.
intervention type: Device
intervention name: Uncertain diagnosis of true labor
description: Multichannel EMG of uterine bioelectrical signals will be recorded using area sensors. The output of the synchronization calculations will be correlated with the time to delivery
arm group label: Uncertain diagnosis of true labor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Subjects must be pregnant
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roger C Young, MD
role: Principal Investigator
affiliation: PreTeL, Inc
facility: 
country: United States
citation: Young RC. Mechanotransduction mechanisms for coordinating uterine contractions in human labor. Reproduction. 2016 Aug;152(2):R51-61. doi: 10.1530/REP-16-0156. Epub 2016 May 10.
PMID: 27165050
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Obstetric Labor, Premature
sharing ipd: Undecided
ipd description: Specific patient EMG tracings may be shared based on unique characteristics of pregnancy subsets.
provided document: 