<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/NCT03281798</url>
  </required_header>
  <id_info>
    <org_study_id>20220117-1</org_study_id>
    <secondary_id>16-008556</secondary_id>
    <nct_id>NCT03281798</nct_id>
    <nct_alias>NCT05368727</nct_alias>
  </id_info>
  <brief_title>Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction</brief_title>
  <acronym>CYSTO</acronym>
  <official_title>Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rodrigo Ruano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to study the outcomes of maternal and fetal patients who are&#xD;
      undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">August 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2027</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants where the procedure was technically performed</measure>
    <time_frame>Day 1 (Post fetal cystoscopy procedure)</time_frame>
    <description>Number of participants where the fetal cystoscopy procedure was successfully technically performed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants where the etiology of LUTO was correctly diagnosed</measure>
    <time_frame>Up to 1 month post delivery</time_frame>
    <description>Number of participants where the etiology of LUTO was correctly diagnosed during fetal cystoscopy as compared to post natal cystoscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants where the posterior urethral valve were successfully released</measure>
    <time_frame>Day 1 (Post fetal cystoscopy procedure)</time_frame>
    <description>Number of participants where the posterior urethral valve were successfully released</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe pulmonary hypoplasia</measure>
    <time_frame>Up to 1 month post delivery</time_frame>
    <description>As per treating physician evaluation of clinical assessments post-natal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe renal impairment</measure>
    <time_frame>Up to 24 months post delivery</time_frame>
    <description>As per treating physician evaluation of clinical assessments post-natal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants whose fetal cystoscopy resulted in maternal complications</measure>
    <time_frame>Day 1 post delivery</time_frame>
    <description>Maternal and obstetrical complications such as preterm premature rupture of the membranes (PPROM), prematurity (birth &lt;37 weeks), extremely preterm birth (&lt;32 weeks), and urological fistulae and fetal demise.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Lower Urinary Tract Obstructive Syndrome</condition>
  <condition>Lower Urinary Tract Obstruction, Congenital</condition>
  <condition>Bladder Outlet Obstruction</condition>
  <condition>Bladder Outflow Obstruction</condition>
  <arm_group>
    <arm_group_label>Fetal Cystoscopy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fetoscopes</intervention_name>
    <description>Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.</description>
    <arm_group_label>Fetal Cystoscopy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fetal Cystoscopy</intervention_name>
    <description>A fetoscope will be inserted into the fetal bladder via the maternal abdomen and advanced into the fetal bladder outlet. Identified obstruction will be opened using laser.</description>
    <arm_group_label>Fetal Cystoscopy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women&#xD;
&#xD;
          2. Singleton pregnancy&#xD;
&#xD;
          3. Maternal age ≥ 18 years&#xD;
&#xD;
          4. Male fetus with LUTO, dilated bladder, &quot;keyhole sign&quot; and bilateral hydronephrosis&#xD;
&#xD;
          5. Oligohydramnios or Anhydramnios&#xD;
&#xD;
          6. Favorable urine analysis defined as urinary sodium is &lt; 100 milliequivalents per liter&#xD;
             (mEq/L), chloride &lt; 90 mEq/L, and osmolality &lt; 200 milliosmoles per kilogram (mOsm/kg)&#xD;
             after 20 weeks and in the absence of previous in utero intervention for the disease&#xD;
             (vesicoamniotic shunt placement or fetal cystoscopy).&#xD;
&#xD;
          7. Absence of chromosomal abnormalities and associated anomalies&#xD;
&#xD;
          8. Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7&#xD;
             weeks&#xD;
&#xD;
          9. Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling&#xD;
             (CVS)). Patients declining invasive testing will be excluded.&#xD;
&#xD;
         10. Family have considered and declined the option of termination of the pregnancy at less&#xD;
             than 24 weeks.&#xD;
&#xD;
         11. Family meets psychosocial criteria, including sufficient social support and ability to&#xD;
             understand requirements of the study.&#xD;
&#xD;
         12. Parents or guardian are willing to provide signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Fetal anomaly unrelated to LUTO&#xD;
&#xD;
          2. Congenital cardiac anomaly&#xD;
&#xD;
          3. Female fetus&#xD;
&#xD;
          4. Increased risk for preterm labor including short cervical length (&lt;1.5 cm), history of&#xD;
             incompetent cervix with or without cerclage, and previous preterm birth&#xD;
&#xD;
          5. Placental abnormalities (previa, abruption, accreta) known at time of enrollment&#xD;
&#xD;
          6. Contraindications to surgery including previous hysterotomy in active uterine segment&#xD;
&#xD;
          7. Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal&#xD;
             membrane separation, uterine anomalies incompatible with fetoscopy&#xD;
&#xD;
          8. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune&#xD;
             thrombocytopenia affecting the current pregnancy&#xD;
&#xD;
          9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk&#xD;
             of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or&#xD;
             Hepatitis status is unknown, the patient must be tested and found to have negative&#xD;
             results before enrollment&#xD;
&#xD;
         10. Maternal medical condition that is a contraindication to surgery or anesthesia&#xD;
&#xD;
         11. Patient does not have health insurance to cover routine clinical care including&#xD;
             prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and&#xD;
             fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is&#xD;
             considered an experimental procedure.&#xD;
&#xD;
         12. Inability to comply with travel and follow-up requirements of the trial&#xD;
&#xD;
         13. Participation in another intervention study that influences maternal and fetal&#xD;
             morbidity and mortality or participation in this trial in a previous pregnancy&#xD;
&#xD;
         14. Patients declining invasive testing&#xD;
&#xD;
         15. Family does not meet psychosocial criteria including insufficient&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rodrigo Ruano, MD, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rodrigo A Ruano, MD, PhD.</last_name>
    <phone>305.243.0769</phone>
    <email>rodrigo.ruano@miami.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rodrigo Ruano, MD, Ph.D</last_name>
      <phone>305-243-0769</phone>
      <email>rodrigo.ruano@miami.edu</email>
    </contact>
    <investigator>
      <last_name>Rodrigo Ruano</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Rodrigo Ruano</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neck Obstruction</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/NCT03281798
org study id: 20220117-1
secondary id: 16-008556
nct id: NCT03281798
nct alias: NCT05368727
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The purpose of the study is to study the outcomes of maternal and fetal patients who are
      undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants where the procedure was technically performed
time frame: Day 1 (Post fetal cystoscopy procedure)
description: Number of participants where the fetal cystoscopy procedure was successfully technically performed.
measure: Number of participants where the etiology of LUTO was correctly diagnosed
time frame: Up to 1 month post delivery
description: Number of participants where the etiology of LUTO was correctly diagnosed during fetal cystoscopy as compared to post natal cystoscopy
measure: Number of participants where the posterior urethral valve were successfully released
time frame: Day 1 (Post fetal cystoscopy procedure)
description: Number of participants where the posterior urethral valve were successfully released
measure: Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe pulmonary hypoplasia
time frame: Up to 1 month post delivery
description: As per treating physician evaluation of clinical assessments post-natal.
measure: Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe renal impairment
time frame: Up to 24 months post delivery
description: As per treating physician evaluation of clinical assessments post-natal.
measure: Number of participants whose fetal cystoscopy resulted in maternal complications
time frame: Day 1 post delivery
description: Maternal and obstetrical complications such as preterm premature rupture of the membranes (PPROM), prematurity (birth <37 weeks), extremely preterm birth (<32 weeks), and urological fistulae and fetal demise.
arm group label: Fetal Cystoscopy Group
arm group type: Experimental
description: Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation.
intervention type: Device
intervention name: Fetoscopes
description: Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.
arm group label: Fetal Cystoscopy Group
intervention type: Procedure
intervention name: Fetal Cystoscopy
description: A fetoscope will be inserted into the fetal bladder via the maternal abdomen and advanced into the fetal bladder outlet. Identified obstruction will be opened using laser.
arm group label: Fetal Cystoscopy Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rodrigo Ruano, MD, PhD.
role: Principal Investigator
affiliation: University of Miami
last name: Rodrigo A Ruano, MD, PhD.
phone: 305.243.0769
email: rodrigo.ruano@miami.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Miami
investigator full name: Rodrigo Ruano
investigator title: Professor
mesh term: Urinary Bladder Neck Obstruction
sharing ipd: No