<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/NCT03829774</url>
  </required_header>
  <id_info>
    <org_study_id>CS/PRv2.0/C-Sec/2019</org_study_id>
    <nct_id>NCT03829774</nct_id>
  </id_info>
  <brief_title>To Study and Evaluate the Effectiveness of Treatment by Percutaneous Electrical NeuroStimulation (PENS) for Post-operative Pain in Cesarean Section Patients Using Primary Relief v 2.0</brief_title>
  <acronym>POPS</acronym>
  <official_title>To Study and Evaluate the Effectiveness of Treatment by Percutaneous Electrical NeuroStimulation (PENS) for Post-operative Pain in Cesarean Section Patients Using Primary Relief v 2.0</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DyAnsys, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DyAnsys, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study and evaluate the Effectiveness of Treatment by Percutaneous Electrical&#xD;
      NeuroStimulation (PENS) for post-operative pain in Cesarean Section patients using First&#xD;
      Relief&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>assessing the effects of PENS therapy in Postoperative period of Lower Segment Caesarean Section pain using VAS score.</measure>
    <time_frame>2 hours of device activation</time_frame>
    <description>To assess the effects of PENS therapy in Post-Operative period of Lower Segment Caesarean Section pain using the Visual Analogue Scale measurement. The level of pain is calculated from the VAS (Visual Analogue Scale) before the device is installed and assessed after 2 hours of the device activation. The pain level should be decreased when assessing after 2 hours of device installation. The score should be below 5. where 0 being no pain, 5 being moderate and 10 being maximum pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the impact of this treatment in terms of Quality Of Life</measure>
    <time_frame>2nd day</time_frame>
    <description>whether treatment can negate the need for more complex surgical treatments and/or reduce the need for drug treatment. Change in quality of life will be measured using the Evaluation form measurement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Cesarean Section; Dehiscence</condition>
  <arm_group>
    <arm_group_label>Primary Relief v 2.0 Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test product or device called Primary Relief v 2.0 device will be used for the study. The study will be conducted for a period of two to three months with the treatment period of 3 - 4 days i.e single treatment (installation). The additional time taken will be to define the characteristics of the patient population and to recruit appropriate patients. Finally, there will be a data analysis and report writing period. Overall, the study is expected to 3 months. The device will be placed onto the auricle part of the ear for percutaneous electrical nerve stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paracetamol</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A control group, receiving a standard treatment as follows: primary choice of analgesic was intravenous Paracetamol , 1 gram, and if the pain relief was inadequate, diclofenac inj. If pain persisted in spite of these measures, 50 mg tramadol was administered intravenously</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Primary Relief v 2.0</intervention_name>
    <description>The test product or device called Primary Relief v 2.0 will be used for the study. The study will be conducted for a period of two to three months with the treatment period of 3 - 4 days i.e single treatment (installation). The additional time taken will be to define the characteristics of the patient population and to recruit appropriate patients. Finally, there will be a data analysis and report writing period. Overall, the study is expected to 3 months. The device will be placed onto the auricle part of the ear for percutaneous electrical nerve stimulation.</description>
    <arm_group_label>Primary Relief v 2.0 Device</arm_group_label>
    <other_name>Percutaeneous Nerve Field Stimulator Neurostimulator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <description>A control group, receiving a standard treatment as follows: primary choice of analgesic was intravenous paracetamol, 1 gram, and if the pain relief was inadequate, diclofenac inj. If pain persisted in spite of these measures, 50 mg tramadol was administered intravenously</description>
    <arm_group_label>Paracetamol</arm_group_label>
    <other_name>Standard Drug Treatment for Postoperative pain</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age range between 22 - 35 years&#xD;
&#xD;
          2. Patient willing to undergo C-section surgery&#xD;
&#xD;
          3. Patient having pains after one hour of post C-Section surgery&#xD;
&#xD;
          4. Patients who is conscious and oriented for device installation after anesthetic effect&#xD;
&#xD;
          5. Patient who completed required clinical and biochemical investigations as deemed&#xD;
             necessary by the gynecologist after post C - section surgery.&#xD;
&#xD;
          6. No previous poor obstetrical outcome&#xD;
&#xD;
          7. No experience in Han's Acupoint nerve stimulator and TENS for other reasons.&#xD;
&#xD;
          8. Term pregnancy (&gt; 37 weeks of gestation).&#xD;
&#xD;
          9. Understands and is willing to participate in the clinical study and can comply with&#xD;
             study procedures.&#xD;
&#xD;
         10. Normal cognitive and communicative ability as judged by clinical assessment and&#xD;
             ability to complete self-reported questionnaires.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Had been diagnosed with other diseases such as preoperative presence of maternal&#xD;
             mental, neurological disease, affecting evaluation of pains and disease condition.&#xD;
&#xD;
          2. Had combined with gestational hypertension, gestational diabetes, gestational thyroid&#xD;
             disease.&#xD;
&#xD;
          3. Had taken analgesic drugs&#xD;
&#xD;
          4. Had used diazepam, piperazine hydrochloride or other sedative, analgesic drugs in the&#xD;
             stage of labor.&#xD;
&#xD;
          5. Were overweight or low pregnancy weight, Body mass index (&lt; 18.5 or &gt;25 kg/m2).&#xD;
&#xD;
          6. Patients who are not agreeing to receive painless labor and not sign the informed&#xD;
             consent form.&#xD;
&#xD;
          7. Neonatal problem requiring immediate separation from the mother for medical care or&#xD;
             NICU admittance.&#xD;
&#xD;
          8. Severe placental abruption.&#xD;
&#xD;
          9. Hydrops (accumulation of fluid or edema in fetus body tissue and cavities) if&#xD;
             secondary to anemia or heart failure.&#xD;
&#xD;
         10. Known twin to twin transfusion syndrome (TTS).&#xD;
&#xD;
         11. Congenital anomalies that may hamper the procedure (gastroschisis, amphalacele, spina&#xD;
             bifida).&#xD;
&#xD;
         12. Home birth.&#xD;
&#xD;
         13. Severe mental health problem&#xD;
&#xD;
         14. Hearing impairment.&#xD;
&#xD;
         15. Legal abortion&#xD;
&#xD;
         16. Twin pregnancy&#xD;
&#xD;
         17. Instrumental birth&#xD;
&#xD;
         18. Uterine anomalies with contraindication for vaginal birth. Eg: previous opening of&#xD;
             uterine cavity, myomectomy, congenital abnormalities.&#xD;
&#xD;
         19. Placenta anomalies.&#xD;
&#xD;
         20. Placenta praevia, suspected acreta, increta, percreta especially after previous&#xD;
             caesarean.&#xD;
&#xD;
         21. Fetal abnormalities, growth restriction.&#xD;
&#xD;
         22. Maternal complication with surgery.&#xD;
&#xD;
         23. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days&#xD;
             preceding screening; or subject or physician anticipates use of any of these therapies&#xD;
             by the subject during the course of the study&#xD;
&#xD;
         24. Previous participation in the Treatment Phase of this Protocol&#xD;
&#xD;
         25. Malignant disease not in remission for five years or more that has been medically or&#xD;
             surgically treated without evidence of metastases&#xD;
&#xD;
         26. Presence of one or more medical conditions, as determined by medical history, which&#xD;
             seriously compromises the subject's ability to complete the study, including history&#xD;
             of poor adherence with medical treatment, unstable pain intensity or pain medications&#xD;
             6 weeks prior to the study, renal, hepatic, hematologic, active auto-immune or immune&#xD;
             diseases that, in the opinion of the Investigator, would make the subject an&#xD;
             inappropriate candidate for this study: a) One or more abnormal blood biochemistry&#xD;
             analyte result that is ≥ 3 times that of the upper limit of the normal range&#xD;
&#xD;
         27. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history&#xD;
             known to be infected with Human Immunodeficiency Virus (HIV)&#xD;
&#xD;
         28. American Heart Association (AHA) Class III and IV congestive heart failure (CHF), as&#xD;
             defined by the following criteria: a) Class III: Symptoms with moderate exertion b)&#xD;
             Class IV: Symptoms at rest or c) Cardiac pacemakers.&#xD;
&#xD;
         29. Subjects with a diagnosis of psychiatric disorders such as major depressive disorder,&#xD;
             bipolar disorder, obsessive compulsive disorder, generalized anxiety, dysthymia or&#xD;
             suicidality/suicide ideation&#xD;
&#xD;
         30. Subjects not willing to undergo treatment before discharge from the hospital.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant Women willing to undergo C-Section</gender_description>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Balachandran V, MD</last_name>
    <phone>+91 9946452707</phone>
    <email>v.balachandran@dyansys.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hariharan A, B.Tech</last_name>
    <phone>+91 8124147672</phone>
    <email>a.hariharan@dyansys.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinic</name>
      <address>
        <city>Warangal</city>
        <state>Telangana</state>
        <zip>506002</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Balachandran V, MD</last_name>
      <phone>9496452707</phone>
      <email>v.balachandaran@dyansys.com</email>
    </contact>
    <contact_backup>
      <last_name>Robin M, GNM</last_name>
      <phone>8722627172</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</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>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
  </intervention_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/NCT03829774
org study id: CS/PRv2.0/C-Sec/2019
nct id: NCT03829774
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To study and evaluate the Effectiveness of Treatment by Percutaneous Electrical
      NeuroStimulation (PENS) for post-operative pain in Cesarean Section patients using First
      Relief
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: assessing the effects of PENS therapy in Postoperative period of Lower Segment Caesarean Section pain using VAS score.
time frame: 2 hours of device activation
description: To assess the effects of PENS therapy in Post-Operative period of Lower Segment Caesarean Section pain using the Visual Analogue Scale measurement. The level of pain is calculated from the VAS (Visual Analogue Scale) before the device is installed and assessed after 2 hours of the device activation. The pain level should be decreased when assessing after 2 hours of device installation. The score should be below 5. where 0 being no pain, 5 being moderate and 10 being maximum pain.
measure: Evaluate the impact of this treatment in terms of Quality Of Life
time frame: 2nd day
description: whether treatment can negate the need for more complex surgical treatments and/or reduce the need for drug treatment. Change in quality of life will be measured using the Evaluation form measurement.
arm group label: Primary Relief v 2.0 Device
arm group type: Experimental
description: The test product or device called Primary Relief v 2.0 device will be used for the study. The study will be conducted for a period of two to three months with the treatment period of 3 - 4 days i.e single treatment (installation). The additional time taken will be to define the characteristics of the patient population and to recruit appropriate patients. Finally, there will be a data analysis and report writing period. Overall, the study is expected to 3 months. The device will be placed onto the auricle part of the ear for percutaneous electrical nerve stimulation.
arm group label: Paracetamol
arm group type: Placebo Comparator
description: A control group, receiving a standard treatment as follows: primary choice of analgesic was intravenous Paracetamol , 1 gram, and if the pain relief was inadequate, diclofenac inj. If pain persisted in spite of these measures, 50 mg tramadol was administered intravenously
intervention type: Device
intervention name: Primary Relief v 2.0
description: The test product or device called Primary Relief v 2.0 will be used for the study. The study will be conducted for a period of two to three months with the treatment period of 3 - 4 days i.e single treatment (installation). The additional time taken will be to define the characteristics of the patient population and to recruit appropriate patients. Finally, there will be a data analysis and report writing period. Overall, the study is expected to 3 months. The device will be placed onto the auricle part of the ear for percutaneous electrical nerve stimulation.
arm group label: Primary Relief v 2.0 Device
other name: Percutaeneous Nerve Field Stimulator Neurostimulator
intervention type: Drug
intervention name: Paracetamol
description: A control group, receiving a standard treatment as follows: primary choice of analgesic was intravenous paracetamol, 1 gram, and if the pain relief was inadequate, diclofenac inj. If pain persisted in spite of these measures, 50 mg tramadol was administered intravenously
arm group label: Paracetamol
other name: Standard Drug Treatment for Postoperative pain
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant Women willing to undergo C-Section
minimum age: 22 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Balachandran V, MD
phone: +91 9946452707
email: v.balachandran@dyansys.com
last name: Hariharan A, B.Tech
phone: +91 8124147672
email: a.hariharan@dyansys.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Acetaminophen
sharing ipd: Undecided