<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/NCT03034616</url>
  </required_header>
  <id_info>
    <org_study_id>029416</org_study_id>
    <nct_id>NCT03034616</nct_id>
  </id_info>
  <brief_title>Ovarian Laparoscopic In Vivo Activation of Ovary for Premature Ovarian Insufficiency</brief_title>
  <acronym>OLIVA</acronym>
  <official_title>in Vivo Activation of Ovarian Cortex in Premature Ovarian Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The OLIVA device will enable to perform shallow slashes on the ovarian cortex in patients&#xD;
      undergoing oophorectomy. Prior to the resection of the ovary from the pedicle we will perform&#xD;
      5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to&#xD;
      the depth of cuts and proximity to blood vessels and later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The OLIVA device is built of 5 parallel razor blades enclosed by protective cap&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depth of cuts and closeness to blood vessel</measure>
    <time_frame>Up to 30 days after procedure</time_frame>
    <description>The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proximity of cuts to blood vessel</measure>
    <time_frame>Up to 30 days after procedure</time_frame>
    <description>The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Primary Ovarian Insufficiency</condition>
  <arm_group>
    <arm_group_label>ex vivo activation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>'OLIVA device' in patients that undergo oophorectomy on the cortex of the removed ovary we will perform 5 parallel slashes 3 cm long.&#xD;
this will be followed by investigation by the pathologist as to the depth of cuts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>in vivo activation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>'OLIVA device' in patients undergoing oophorectomy before the resection from is pedicle on cortex of the ovary we will perform 5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to the depth of cuts and proximity to blood vessels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POI OLIVA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>'OLIVA device' in patients with premature ovarian failure and following safety data from arm 2 activation by ovarian slashing will be performed laparoscopically by closed cutting device (OLIVA). follow-up by sonography and hormonal markers of ovarian activity</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OLIVA device</intervention_name>
    <description>OLIVA device is a laparoscopic device with a standard handle and a tip built of 5 parallel razor blades enclosed by protective cap opened by a separate button.&#xD;
This device will enable to perform shallow slashes on the ovarian cortex following the grasping of the ovary without damaging other abdominal and pelvic organs</description>
    <arm_group_label>POI OLIVA</arm_group_label>
    <arm_group_label>ex vivo activation</arm_group_label>
    <arm_group_label>in vivo activation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Peri/menopausal women undergoing laparoscopic oophorectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with ovarian malignancy&#xD;
&#xD;
          -  Women with polycystic ovarian syndrome&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hadassah Medical Organization</investigator_affiliation>
    <investigator_full_name>Ariel Revel</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Primary ovarian insufficiency</keyword>
  <keyword>In-vivo activation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Primary Ovarian Insufficiency</mesh_term>
    <mesh_term>Menopause, Premature</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03034616
org study id: 029416
nct id: NCT03034616
lead sponsor: 
has dmc: No
The OLIVA device will enable to perform shallow slashes on the ovarian cortex in patients
      undergoing oophorectomy. Prior to the resection of the ovary from the pedicle we will perform
      5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to
      the depth of cuts and proximity to blood vessels and later.
The OLIVA device is built of 5 parallel razor blades enclosed by protective cap
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Depth of cuts and closeness to blood vessel
time frame: Up to 30 days after procedure
description: The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device
measure: Proximity of cuts to blood vessel
time frame: Up to 30 days after procedure
description: The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device
arm group label: ex vivo activation
arm group type: Experimental
description: 'OLIVA device' in patients that undergo oophorectomy on the cortex of the removed ovary we will perform 5 parallel slashes 3 cm long.
this will be followed by investigation by the pathologist as to the depth of cuts.
arm group label: in vivo activation
arm group type: Active Comparator
description: 'OLIVA device' in patients undergoing oophorectomy before the resection from is pedicle on cortex of the ovary we will perform 5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to the depth of cuts and proximity to blood vessels.
arm group label: POI OLIVA
arm group type: Active Comparator
description: 'OLIVA device' in patients with premature ovarian failure and following safety data from arm 2 activation by ovarian slashing will be performed laparoscopically by closed cutting device (OLIVA). follow-up by sonography and hormonal markers of ovarian activity
intervention type: Device
intervention name: OLIVA device
description: OLIVA device is a laparoscopic device with a standard handle and a tip built of 5 parallel razor blades enclosed by protective cap opened by a separate button.
This device will enable to perform shallow slashes on the ovarian cortex following the grasping of the ovary without damaging other abdominal and pelvic organs
arm group label: POI OLIVA
arm group label: ex vivo activation
arm group label: in vivo activation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Hadassah Medical Organization
investigator full name: Ariel Revel
investigator title: Principal investigator
mesh term: Primary Ovarian Insufficiency
mesh term: Menopause, Premature
sharing ipd: No