<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/NCT01730963</url>
  </required_header>
  <id_info>
    <org_study_id>RRT-12-01</org_study_id>
    <nct_id>NCT01730963</nct_id>
  </id_info>
  <brief_title>Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians</brief_title>
  <official_title>Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Reproductive Research Technologies, LP</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Reproductive Research Technologies, LP</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multi-reader multi-case study was designed to evaluate the performance of SureCALL®&#xD;
      Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor&#xD;
      intended to measure uterine activity. It is intended for use on pregnant women, with&#xD;
      singleton pregnancies, using surface electrodes on the maternal abdomen. The device is&#xD;
      intended for use by healthcare professionals in a clinical setting.&#xD;
&#xD;
      This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to&#xD;
      the predicate Tocodynamometer device (TOCO).&#xD;
&#xD;
      This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a&#xD;
      Gestation Age of greater than 36 and not in labor at five clinical sites. Each study subject&#xD;
      was instrumented with two technologies for measuring uterine activity:&#xD;
&#xD;
        1. Standard tocodynamometer attached to the maternal abdomen,&#xD;
&#xD;
        2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography&#xD;
           attached to the maternal abdomen&#xD;
&#xD;
      An assessment was obtained and quantified from masked, qualified clinical obstetrician&#xD;
      readers for the evaluation of the equivalence of both labor monitor devices by identifying in&#xD;
      isolation the individual uterine contraction signals and the peak of each contraction signal&#xD;
      as recorded by each labor monitor device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers</measure>
    <time_frame>9 - 41 Minutes</time_frame>
    <description>Agreement will be assessed by coefficient of individual agreement (CIA) derived from a dataset of all Reader-marked contractions. In addition, sensitivity and false positive rate per hours will be estimated for each patient by each reader. If CIA ≥ 0.445 (Barnhart, 2007, section 3) or CIA&gt;0.8, Pan 2010), the SureCALL® is not significantly different than the TOCO.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Pregnant, Preterm, In Labor</arm_group_label>
    <description>Gestation Age at or less than 36 weeks, clinically determined to be in labor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregnant, Preterm, Nonlaboring</arm_group_label>
    <description>Gestation Age at or less than 36 weeks, clinically determined to not be in labor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregnant, Term, Nonlaboring</arm_group_label>
    <description>Gestation Age more than 36 weeks, clinically determined to not be in labor</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women with uncomplicated singleton pregnancies&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton Pregnancy&#xD;
&#xD;
          -  Informed Consent Required&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multifetal Pregnancy&#xD;
&#xD;
          -  Informed Consent Not Given&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Timothy B Waterhouse, MD</last_name>
    <role>Study Director</role>
    <affiliation>Reproductive Research Technologies, LP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph's Hospital and Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel University College of Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Texas OB/GYN Associates</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woman's Hospital of Texas</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 20, 2012</last_update_submitted>
  <last_update_submitted_qc>November 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01730963
org study id: RRT-12-01
nct id: NCT01730963
lead sponsor: 
has dmc: No
This multi-reader multi-case study was designed to evaluate the performance of SureCALL®
      Labor Monitor® (SureCALL®) directly to the standard Tocodynamometer device (TOCO).
The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor
      intended to measure uterine activity. It is intended for use on pregnant women, with
      singleton pregnancies, using surface electrodes on the maternal abdomen. The device is
      intended for use by healthcare professionals in a clinical setting.

      This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to
      the predicate Tocodynamometer device (TOCO).

      This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a
      Gestation Age of greater than 36 and not in labor at five clinical sites. Each study subject
      was instrumented with two technologies for measuring uterine activity:

        1. Standard tocodynamometer attached to the maternal abdomen,

        2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography
           attached to the maternal abdomen

      An assessment was obtained and quantified from masked, qualified clinical obstetrician
      readers for the evaluation of the equivalence of both labor monitor devices by identifying in
      isolation the individual uterine contraction signals and the peak of each contraction signal
      as recorded by each labor monitor device.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers
time frame: 9 - 41 Minutes
description: Agreement will be assessed by coefficient of individual agreement (CIA) derived from a dataset of all Reader-marked contractions. In addition, sensitivity and false positive rate per hours will be estimated for each patient by each reader. If CIA ≥ 0.445 (Barnhart, 2007, section 3) or CIA>0.8, Pan 2010), the SureCALL® is not significantly different than the TOCO.
arm group label: Pregnant, Preterm, In Labor
description: Gestation Age at or less than 36 weeks, clinically determined to be in labor
arm group label: Pregnant, Preterm, Nonlaboring
description: Gestation Age at or less than 36 weeks, clinically determined to not be in labor
arm group label: Pregnant, Term, Nonlaboring
description: Gestation Age more than 36 weeks, clinically determined to not be in labor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Timothy B Waterhouse, MD
role: Study Director
affiliation: Reproductive Research Technologies, LP
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor