<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/NCT03227978</url>
  </required_header>
  <id_info>
    <org_study_id>1060006968</org_study_id>
    <nct_id>NCT03227978</nct_id>
  </id_info>
  <brief_title>PCL (Poly-ε-caprolactone) Mesh Pleurodesis</brief_title>
  <official_title>PCL (Poly-ε-caprolactone) Mesh Pleurodesis in Thoracoscopic Treatment of Primary Spontaneous Pneumothorax</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Recent advances in thoracoscopic surgery have made it a commonly used technique for treating&#xD;
      spontaneous pneumothoraces and preventing recurrence. The goal of surgical treatment is to&#xD;
      find the offending bleb, remove it, and do some manipulation to encourage pleural symphysis.&#xD;
      Methods of thoracoscopic pleural symphysis have included mechanical abrasion and instillation&#xD;
      of chemical irritants. Each method reduces the rate of pneumothorax recurrence to a certain&#xD;
      degree, but the recurrence rates after thoracoscopic surgery are widely varied in the&#xD;
      literature. Although several articles show significantly lower rates, there are also articles&#xD;
      demonstrating that the recurrence rates of pneumothorax after thoracoscopic surgery ranged&#xD;
      between 5 and 12%, which are higher than the rates reported after open thoracotomy. It is&#xD;
      suggested that a less intense pleural inflammatory reaction is induced by thoracoscopic&#xD;
      procedure than by thoracotomy. Besides, post-pleurodesis severe pain and bleeding were&#xD;
      encountered frequently. A potential alternative to increase the intensity of pleural&#xD;
      inflammation and thereby prevent pneumothorax recurrence is film pleurodesis. Only few&#xD;
      studies have been reported where more than one film pleurodesis has been tried, and the&#xD;
      mechanism of film pleurodesis remains unclear.&#xD;
&#xD;
      Poly-ε-caprolactone (PCL) is a FDA-approved biomaterial with a slow degradation time of&#xD;
      approximately 24 months when degraded by hydrolysis only. Recently, some investigators&#xD;
      combined PCL with other biomaterials such as chitosan, polyethylene glycol, hyaluronic acid&#xD;
      to produce anti-adhesion barrier for clinical applications. However, only few studies report&#xD;
      PCL only could provide anti-adhesion effect. In contrast to common complications of&#xD;
      postoperative abdominal adhesions, adhesion (or pleurodesis) is an important therapeutic tool&#xD;
      to control the incidence of recurrent pneumothorax. We suppose that if a biomaterial induces&#xD;
      adhesion following abdominal surgery, perhaps it may be applied to pleurodesis tool for&#xD;
      preventing recurrence of spontaneous pneumothorax. We hypothesized that PCL membrane-induced&#xD;
      pleurodesis can be achieved intrapleurally.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary spontaneous pneumothorax usually occurs in young, lean young men. In most cases, the&#xD;
      cause of pneumothorax is rupture of blebs at the apex of the lung. Traditionally, bullectomy&#xD;
      with mechanical pleurodesis through thoracotomy is indicated in patients with recurrence or&#xD;
      persisted air leakage. The possible causes of recurrent pneumothorax and prolonged air&#xD;
      leakage are missed bleb surrounding the endoscopic suture line or suboptimal suturing or&#xD;
      healing of the thoracoscopic suture. To prevent these complications, a novel method using&#xD;
      coverage of the endoscopic suture line by a large absorbable vicryl mesh during thoracoscopic&#xD;
      surgery was proved to be safe and feasible. Theoretically, the mesh can strengthen the suture&#xD;
      line and induce local fibrosis surrounding the suture line, and reduce the rate of recurrent&#xD;
      pneumothorax and prolonged air leakage. To prove this hypothesis, we will conduct a&#xD;
      prospective randomized trial in National Taiwan University Hospital. We will enroll 10&#xD;
      patients with primary spontaneous pneumothorax who will be assigned to PCL mesh pleurodesis&#xD;
      after thoracoscopic bullectomy and pleural abrasion. The primary endpoint is to check the&#xD;
      biocompatibility of PCL mesh. The secondary endpoint is to evaluate the safety after&#xD;
      thoracoscopic bullectomy and pleural abrasion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2018</primary_completion_date>
  <phase>Early Phase 1</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>blood pressure and temperature</measure>
    <time_frame>three days</time_frame>
    <description>mmHg and celsius degree</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain scale</measure>
    <time_frame>3 days, 1 month and 6 months</time_frame>
    <description>from 0 to 9</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>PCL Pleurodesis</condition>
  <arm_group>
    <arm_group_label>PCL mesh group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: The participants will be received thoracoscopic bullectomy and abrasion of pleura, then PCL mesh will be applied over the lung.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>PCL mesh pleurodesis</intervention_name>
    <description>Coverage of the lung surface by PCL mesh</description>
    <arm_group_label>PCL mesh group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary spontaneous pneumothorax patients who require thoracoscopic bullectomy and&#xD;
             pleurodesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic obstructive pulmonary disease, hemopneumothorax, catamenial pneumothorax,&#xD;
             pregnant, malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Shing Chen, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ke-Cheng Chen, M.D., Ph.D.</last_name>
    <phone>+886975363798</phone>
    <email>cskchen@gmail.com</email>
  </overall_contact>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 19, 2017</last_update_submitted>
  <last_update_submitted_qc>July 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pleurodesis</keyword>
  <keyword>PCL</keyword>
  <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/NCT03227978
org study id: 1060006968
nct id: NCT03227978
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Recent advances in thoracoscopic surgery have made it a commonly used technique for treating
      spontaneous pneumothoraces and preventing recurrence. The goal of surgical treatment is to
      find the offending bleb, remove it, and do some manipulation to encourage pleural symphysis.
      Methods of thoracoscopic pleural symphysis have included mechanical abrasion and instillation
      of chemical irritants. Each method reduces the rate of pneumothorax recurrence to a certain
      degree, but the recurrence rates after thoracoscopic surgery are widely varied in the
      literature. Although several articles show significantly lower rates, there are also articles
      demonstrating that the recurrence rates of pneumothorax after thoracoscopic surgery ranged
      between 5 and 12%, which are higher than the rates reported after open thoracotomy. It is
      suggested that a less intense pleural inflammatory reaction is induced by thoracoscopic
      procedure than by thoracotomy. Besides, post-pleurodesis severe pain and bleeding were
      encountered frequently. A potential alternative to increase the intensity of pleural
      inflammation and thereby prevent pneumothorax recurrence is film pleurodesis. Only few
      studies have been reported where more than one film pleurodesis has been tried, and the
      mechanism of film pleurodesis remains unclear.

      Poly-ε-caprolactone (PCL) is a FDA-approved biomaterial with a slow degradation time of
      approximately 24 months when degraded by hydrolysis only. Recently, some investigators
      combined PCL with other biomaterials such as chitosan, polyethylene glycol, hyaluronic acid
      to produce anti-adhesion barrier for clinical applications. However, only few studies report
      PCL only could provide anti-adhesion effect. In contrast to common complications of
      postoperative abdominal adhesions, adhesion (or pleurodesis) is an important therapeutic tool
      to control the incidence of recurrent pneumothorax. We suppose that if a biomaterial induces
      adhesion following abdominal surgery, perhaps it may be applied to pleurodesis tool for
      preventing recurrence of spontaneous pneumothorax. We hypothesized that PCL membrane-induced
      pleurodesis can be achieved intrapleurally.
Primary spontaneous pneumothorax usually occurs in young, lean young men. In most cases, the
      cause of pneumothorax is rupture of blebs at the apex of the lung. Traditionally, bullectomy
      with mechanical pleurodesis through thoracotomy is indicated in patients with recurrence or
      persisted air leakage. The possible causes of recurrent pneumothorax and prolonged air
      leakage are missed bleb surrounding the endoscopic suture line or suboptimal suturing or
      healing of the thoracoscopic suture. To prevent these complications, a novel method using
      coverage of the endoscopic suture line by a large absorbable vicryl mesh during thoracoscopic
      surgery was proved to be safe and feasible. Theoretically, the mesh can strengthen the suture
      line and induce local fibrosis surrounding the suture line, and reduce the rate of recurrent
      pneumothorax and prolonged air leakage. To prove this hypothesis, we will conduct a
      prospective randomized trial in National Taiwan University Hospital. We will enroll 10
      patients with primary spontaneous pneumothorax who will be assigned to PCL mesh pleurodesis
      after thoracoscopic bullectomy and pleural abrasion. The primary endpoint is to check the
      biocompatibility of PCL mesh. The secondary endpoint is to evaluate the safety after
      thoracoscopic bullectomy and pleural abrasion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: blood pressure and temperature
time frame: three days
description: mmHg and celsius degree
measure: pain scale
time frame: 3 days, 1 month and 6 months
description: from 0 to 9
arm group label: PCL mesh group
arm group type: Experimental
description: Intervention: The participants will be received thoracoscopic bullectomy and abrasion of pleura, then PCL mesh will be applied over the lung.
intervention type: Combination Product
intervention name: PCL mesh pleurodesis
description: Coverage of the lung surface by PCL mesh
arm group label: PCL mesh group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Jin-Shing Chen, M.D., Ph.D.
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Ke-Cheng Chen, M.D., Ph.D.
phone: +886975363798
email: cskchen@gmail.com
responsible party type: Sponsor
sharing ipd: Undecided