<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/NCT03259191</url>
  </required_header>
  <id_info>
    <org_study_id>GI of Zhongda</org_study_id>
    <nct_id>NCT03259191</nct_id>
  </id_info>
  <brief_title>Anti-reflux Mucosectomy (ARMS) is a Useful Therapy for Refractory Gastroesophageal Reflux Disease (RGERD)</brief_title>
  <official_title>Department of Gastroenterology, Zhongda Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruihua Shi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongda Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux&#xD;
      disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 20, 2017</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of symptoms</measure>
    <time_frame>1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>Improvement of all the symptoms related with RGERD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications of ARMS</measure>
    <time_frame>1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>Complications of ARMS,such as esophageal stenosis and dysphagia.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Refractory Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>completely circumferential ARMS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>semi-circumferential ARMS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>anti-reflux mucosectomy</intervention_name>
    <description>Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.</description>
    <arm_group_label>completely circumferential ARMS</arm_group_label>
    <arm_group_label>semi-circumferential ARMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Full sufficiency in literacy&#xD;
&#xD;
          2. Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks&#xD;
&#xD;
          3. Refractory gastroesophageal reflux disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe heart, lung, and cerebrovascular disease&#xD;
&#xD;
          2. Severe hematopoietic system disease&#xD;
&#xD;
          3. Abnormal blood coagulation function&#xD;
&#xD;
          4. Oropharyngeal abnormalities&#xD;
&#xD;
          5. Severe spine malformation&#xD;
&#xD;
          6. In pregnancy and lactation at present, or plan to become pregnant within 2 years&#xD;
&#xD;
          7. Severe inflammation or huge ulcers in stomach&#xD;
&#xD;
          8. Mental and psychological disorde&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huiping Wang</last_name>
    <role>Study Chair</role>
    <affiliation>Zhongda Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ruihua Shi, MD,PhD</last_name>
    <phone>+8613951799326</phone>
    <email>ruihuashi@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jiacheng Tan, MD,PhD</last_name>
    <phone>+8615105165989</phone>
    <email>cencen_njjs@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhongda Hospital Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiacheng Tan</last_name>
      <phone>8615105165989</phone>
      <email>cencen_njjs@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 20, 2017</last_update_submitted>
  <last_update_submitted_qc>August 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
    <investigator_full_name>Ruihua Shi</investigator_full_name>
    <investigator_title>MD, PhD, Postdoctoral Mentor, Chief Physician</investigator_title>
  </responsible_party>
  <keyword>Anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis, Peptic</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/NCT03259191
org study id: GI of Zhongda
nct id: NCT03259191
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux
      disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Improvement of symptoms
time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
description: Improvement of all the symptoms related with RGERD.
measure: Complications of ARMS
time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
description: Complications of ARMS,such as esophageal stenosis and dysphagia.
arm group label: completely circumferential ARMS
arm group type: Other
arm group label: semi-circumferential ARMS
arm group type: Other
intervention type: Procedure
intervention name: anti-reflux mucosectomy
description: Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.
arm group label: completely circumferential ARMS
arm group label: semi-circumferential ARMS
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Huiping Wang
role: Study Chair
affiliation: Zhongda Hospital
last name: Ruihua Shi, MD,PhD
phone: +8613951799326
email: ruihuashi@126.com
last name: Jiacheng Tan, MD,PhD
phone: +8615105165989
email: cencen_njjs@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Zhongda Hospital
investigator full name: Ruihua Shi
investigator title: MD, PhD, Postdoctoral Mentor, Chief Physician
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic
sharing ipd: No