<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/NCT03024242</url>
  </required_header>
  <id_info>
    <org_study_id>TVS</org_study_id>
    <nct_id>NCT03024242</nct_id>
  </id_info>
  <brief_title>Tight Vaginoscopy: a Simplified Novel Technique for a Better Vaginal Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bivalve vaginal speculum insertion is a basic final step of vaginal examination.&#xD;
      Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow&#xD;
      vagina, women with vaginismus or patients with a history of previous vaginal surgery. In such&#xD;
      cases, the value of vaginoscopy (examination of the vagina without speculum) is evident.&#xD;
      Indications of vaginoscopy are expanding. In addition to confirmation of suspected vaginal&#xD;
      masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal wall in&#xD;
      girls due to foreign body , traumatic injuries or sexual abuse. In a systematic review, the&#xD;
      effectiveness and feasibility of using hysteroscopy for exploration of the immature genital&#xD;
      tract (vaginoscopy) were documented.It may help in the diagnosis and treatment of gynecologic&#xD;
      disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow&#xD;
      vagina. Another recent systematic review highlighted the importance of Vagino-hysteroscopy as&#xD;
      an easy way to gain access to the cervical canal and an important tool with which to diagnose&#xD;
      and treat vaginal lesions.&#xD;
&#xD;
      In practice, we notice leakage of excessive irrigating fluid per vagina with poor&#xD;
      visualization during vaginoscopy. To the best of our knowledge, no study addressed a solution&#xD;
      to improve visualization and success of vaginoscopic surgery. This study aims to test&#xD;
      feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy if&#xD;
      compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic surgery&#xD;
      in patients with vaginal or cervical lesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The success rate of the procedure</measure>
    <time_frame>20 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The satisfaction rate by satisfaction score</measure>
    <time_frame>20 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Endosalpingiosis</condition>
  <arm_group>
    <arm_group_label>Tight vaginoscope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The vaginoscope was extracted and loaded inside a thick rubber ring before its reinsertion inside the vagina again. To avoid leakage from the center of the thick rubber ring, the vaginoscopy is inserted through a premade central cruciate incision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tight vaginoscope</intervention_name>
    <arm_group_label>Tight vaginoscope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatizing women with suspected narrow vagina.&#xD;
&#xD;
          -  Nulliparous women or virgin w&#xD;
&#xD;
          -  Vaginal or cervical lesion or foreign body.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiparous women&#xD;
&#xD;
          -  Nulliparous women with patulous or lax vaginae were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women Health Hospital - Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Khairy Ali</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03024242
org study id: TVS
nct id: NCT03024242
lead sponsor: 
has dmc: No
Bivalve vaginal speculum insertion is a basic final step of vaginal examination.
      Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow
      vagina, women with vaginismus or patients with a history of previous vaginal surgery. In such
      cases, the value of vaginoscopy (examination of the vagina without speculum) is evident.
      Indications of vaginoscopy are expanding. In addition to confirmation of suspected vaginal
      masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal wall in
      girls due to foreign body , traumatic injuries or sexual abuse. In a systematic review, the
      effectiveness and feasibility of using hysteroscopy for exploration of the immature genital
      tract (vaginoscopy) were documented.It may help in the diagnosis and treatment of gynecologic
      disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow
      vagina. Another recent systematic review highlighted the importance of Vagino-hysteroscopy as
      an easy way to gain access to the cervical canal and an important tool with which to diagnose
      and treat vaginal lesions.

      In practice, we notice leakage of excessive irrigating fluid per vagina with poor
      visualization during vaginoscopy. To the best of our knowledge, no study addressed a solution
      to improve visualization and success of vaginoscopic surgery. This study aims to test
      feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy if
      compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic surgery
      in patients with vaginal or cervical lesions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The success rate of the procedure
time frame: 20 minutes
measure: The satisfaction rate by satisfaction score
time frame: 20 minutes
arm group label: Tight vaginoscope
arm group type: Experimental
description: The vaginoscope was extracted and loaded inside a thick rubber ring before its reinsertion inside the vagina again. To avoid leakage from the center of the thick rubber ring, the vaginoscopy is inserted through a premade central cruciate incision.
intervention type: Device
intervention name: Tight vaginoscope
arm group label: Tight vaginoscope
criteria: 
gender: Female
minimum age: 10 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Khairy Ali
investigator title: Lecturer
sharing ipd: Yes