<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/NCT04434781</url>
  </required_header>
  <id_info>
    <org_study_id>1708840627</org_study_id>
    <nct_id>NCT04434781</nct_id>
  </id_info>
  <brief_title>Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis</brief_title>
  <acronym>G-POEM</acronym>
  <official_title>Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis: A Database Repository</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>No</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>
      Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of&#xD;
      Gastroparesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastroparesis is a disease of the stomach where there is significant delay in gastric&#xD;
      emptying of contents to the intestines. This disease results in a multitude of symptoms&#xD;
      including nausea, vomiting, weight loss, and malnutrition.&#xD;
&#xD;
      Current treatments for gastroparesis include dietary changes, oral medications (prokinetic&#xD;
      agents to enhance gastric motility, acid reducers, anti-emetics to reduce nausea and&#xD;
      vomiting), gastric stimulators and rarely surgery.&#xD;
&#xD;
      G-POEM (Gastric Per-Oral Endoscopic Myotomy-creating a cut in the muscle that controls&#xD;
      gastric emptying), an incision-less (no cutting of the surface of the body) endoscopic&#xD;
      procedure, is increasingly being performed to assist in the management of certain groups of&#xD;
      patients with gastroparesis.&#xD;
&#xD;
      This data will be used for research purposes only to determine the clinical impact of&#xD;
      endoscopic treatments on gastroparesis. The physicians will also be able to better understand&#xD;
      the patient's condition and disease process that may lead to improved standard of care and&#xD;
      improved patient management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 7, 2018</start_date>
  <completion_date type="Anticipated">August 15, 2026</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM</measure>
    <time_frame>60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month &amp; 60 months</time_frame>
    <description>The Gastroparesis Cardinal Symptom Index (GCSI) is used for assessing severity of symptoms associated with gastroparesis. Patients are to score each of the 9 symptom criteria on 0 (None) to 5 (Very Severe) Likert Scale. The higher the score the more symptomatic from gastroparesis the patient is.&#xD;
Nausea or Vomiting (score 0-5 for each of the following 3 criteria)&#xD;
Nausea&#xD;
Retching&#xD;
Vomiting Postprandial fullness or early satiety (score 0-5 for each of the following 4 criteria)&#xD;
Stomach Fullness&#xD;
Not able to finish a normal-sized meal&#xD;
Feeling excessively full after meals&#xD;
Loss of appetite Bloating (score 0-5 for each of the following 2 criteria)&#xD;
Bloating&#xD;
Stomach visibly larger</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM</measure>
    <time_frame>60 months span: baseline and assess change at 1,3,6,12,24, 36,48 &amp; 60 months</time_frame>
    <description>Change in PAGI-Sym score: The PAGI-SYM is composed of 20 items and 6 subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEM</measure>
    <time_frame>baseline and assess change at 1,3,6,12,24,36,48 &amp; 60 months</time_frame>
    <description>Change in health belief questionnaire (SF-36) score: Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability and the higher scores indicate better health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEM</measure>
    <time_frame>baseline; and assess change at 6, and 24 months</time_frame>
    <description>we will track change in GES at 6 months and 24 months post G-POEM and compare to baseline. Normal GES should have under 5% at 4 hours</description>
  </primary_outcome>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Gastroparesis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        As long as patients fall under the inclusion criteria and do not fall under exclusions,&#xD;
        every patient can be considered. Patient must be declared safe to undergo procedure on&#xD;
        individual basis from an evaluation from head doctor on study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age&#xD;
&#xD;
          -  Referral for endoscopic treatment of Gastroparesis for symptom management&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  Absence of gastroparesis based on scintigraphy studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad Al-Haddad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jacque Peterman</last_name>
    <phone>317-944-0980</phone>
    <email>petermaj@iu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohammad Al-Haddad, MD</last_name>
    <phone>317-944-0980</phone>
    <email>moalhadd@iu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Indiana University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad Al-Haddad, MD</last_name>
      <phone>317-944-0980</phone>
      <email>moalhadd@iu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>October 10, 2018</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>May 24, 2023</last_update_submitted>
  <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Mohammad Al-Haddad</investigator_full_name>
    <investigator_title>Associate Professor of Medicine, Associate Clinical Director</investigator_title>
  </responsible_party>
  <keyword>GPOEM</keyword>
  <keyword>Gastric Per-Oral Endoscopic Myotomy</keyword>
  <keyword>Myotomy</keyword>
  <keyword>Gastroparesis</keyword>
  <keyword>g-poem</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04434781
org study id: 1708840627
nct id: NCT04434781
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of
      Gastroparesis.
Gastroparesis is a disease of the stomach where there is significant delay in gastric
      emptying of contents to the intestines. This disease results in a multitude of symptoms
      including nausea, vomiting, weight loss, and malnutrition.

      Current treatments for gastroparesis include dietary changes, oral medications (prokinetic
      agents to enhance gastric motility, acid reducers, anti-emetics to reduce nausea and
      vomiting), gastric stimulators and rarely surgery.

      G-POEM (Gastric Per-Oral Endoscopic Myotomy-creating a cut in the muscle that controls
      gastric emptying), an incision-less (no cutting of the surface of the body) endoscopic
      procedure, is increasingly being performed to assist in the management of certain groups of
      patients with gastroparesis.

      This data will be used for research purposes only to determine the clinical impact of
      endoscopic treatments on gastroparesis. The physicians will also be able to better understand
      the patient's condition and disease process that may lead to improved standard of care and
      improved patient management.
observational model: Other
time perspective: Prospective
measure: Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM
time frame: 60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months
description: The Gastroparesis Cardinal Symptom Index (GCSI) is used for assessing severity of symptoms associated with gastroparesis. Patients are to score each of the 9 symptom criteria on 0 (None) to 5 (Very Severe) Likert Scale. The higher the score the more symptomatic from gastroparesis the patient is.
Nausea or Vomiting (score 0-5 for each of the following 3 criteria)
Nausea
Retching
Vomiting Postprandial fullness or early satiety (score 0-5 for each of the following 4 criteria)
Stomach Fullness
Not able to finish a normal-sized meal
Feeling excessively full after meals
Loss of appetite Bloating (score 0-5 for each of the following 2 criteria)
Bloating
Stomach visibly larger
measure: Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM
time frame: 60 months span: baseline and assess change at 1,3,6,12,24, 36,48 & 60 months
description: Change in PAGI-Sym score: The PAGI-SYM is composed of 20 items and 6 subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe)
measure: Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEM
time frame: baseline and assess change at 1,3,6,12,24,36,48 & 60 months
description: Change in health belief questionnaire (SF-36) score: Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability and the higher scores indicate better health
measure: Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEM
time frame: baseline; and assess change at 6, and 24 months
description: we will track change in GES at 6 months and 24 months post G-POEM and compare to baseline. Normal GES should have under 5% at 4 hours
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mohammad Al-Haddad, MD
role: Principal Investigator
affiliation: Indiana University
last name: Jacque Peterman
phone: 317-944-0980
email: petermaj@iu.edu
last name: Mohammad Al-Haddad, MD
phone: 317-944-0980
email: moalhadd@iu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Mohammad Al-Haddad
investigator title: Associate Professor of Medicine, Associate Clinical Director
mesh term: Gastroparesis