xml: <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/NCT05992103</url>
    </required_header>
    <id_info>
      <org_study_id>PS-002</org_study_id>
      <nct_id>NCT05992103</nct_id>
    </id_info>
    <brief_title>ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss)</brief_title>
    <acronym>AW2</acronym>
    <official_title>Single-Stage Gastric Fundus Ablation and Endoscopic Sleeve Gastroplasty for Weight Loss</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>True You Weight Loss</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>True You Weight Loss</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research is to investigate the combined effects of fundic ablation (FA)&#xD;
        and endoscopic sleeve gastroplasty on circulating plasma ghrelin, satiation, and total body&#xD;
        weight loss, as well as the incidence of adverse events. This procedure will be carried out&#xD;
        with the HybridAPC (ERBE Elektromedizin GmbH, Tübingen, Germany). The HybridAPC instrument&#xD;
        creates an electric current to deliver a safe amount of thermal injury to a portion of the&#xD;
        stomach known as the gastric fundus. This thermal injury will target a hormone called ghrelin&#xD;
        which is the only known hormone linked to increasing appetite, calorie intake, and weight&#xD;
        gain. This procedure is designed to target the bodily effects of appetite control and gastric&#xD;
        sensory and motor functions which cause the feeling of fullness and satiation. When fundic&#xD;
        mucosal ablation is paired with endoscopic sleeve gastroplasty (ESG), this combined&#xD;
        investigational approach may lead to decreased fasting ghrelin levels, improved satiation,&#xD;
        and greater total body weight loss than traditional ESG. This study will help determine if&#xD;
        the combined impact of FA with ESG within the same endoscopic session should be made&#xD;
        available to patients as part of a comprehensive weight loss strategy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure&#xD;
        and mediated by multiple central and peripheral pathways that may serve as targets for&#xD;
        therapeutic interventions. The endoscopic sleeve gastroplasty (ESG) is a per oral gastric&#xD;
        remodeling technique that employs full-thickness suturing to imbricate the stomach along the&#xD;
        greater curvature to achieve a restricted, sleeve-like configuration. While the ESG&#xD;
        recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as&#xD;
        robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major&#xD;
        difference between ESG and LSG is that the former does not involve the gastric fundus. The&#xD;
        proximal stomach, and the fundus in particular, produces ghrelin, the only known orexigenic&#xD;
        hormone, which has been linked to increased calorie intake and weight gain. Studies have&#xD;
        observed reduced levels of ghrelin along multiple timepoints following LSG, and this has been&#xD;
        attributed to targeting of the fundus, as bariatric surgeries that did not involve the fundus&#xD;
        did not see a decrease in circulating plasma ghrelin. In contrast, in a small comparative&#xD;
        study of ESG and LSG, patients who had undergone ESG did not show any decrease in fasting&#xD;
        ghrelin levels, 8 ostensibly due to fundic-sparing. In this study, the investigators propose&#xD;
        to investigate the effects of fundic ablation (FA-ESG) on total body weight loss (TBWL) as&#xD;
        well as the incidence of adverse events. Fundic ablation will be followed with ESG, to&#xD;
        evaluate the combined impact of FA and ESG (FA-ESG). This study hypothesizes that the&#xD;
        combined endoscopic intervention (FA-ESG) will result in significant weight loss while&#xD;
        maintaining an acceptable safety profile&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 14, 2023</start_date>
    <completion_date type="Anticipated">May 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 14, 2025</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>Rate of Safety Complications</measure>
      <time_frame>Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12</time_frame>
      <description>Occurrence of Grade III - V complications according to the Clavien-Dindo classification</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of Adverse Events</measure>
      <time_frame>Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12</time_frame>
      <description>Occurrence of Adverse Events and Serious Adverse Events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percent Change in Total Body Weight Loss (TBWL) from Baseline</measure>
      <time_frame>Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12</time_frame>
      <description>Measure percent change in total body weight over time following FA-ESG. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Fundic Ablation in Combination with Endoscopic Sleeve Gastroplasty</intervention_name>
      <description>Fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the treatment of adults with obesity</description>
      <arm_group_label>Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Fundic Mucosal Ablation with ERBE HybridAPC</intervention_name>
      <description>Fundic mucosal ablation utilizing approved ERBE HybridAPC</description>
      <arm_group_label>Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Apollo ESG</intervention_name>
      <description>Using only Apollo ESG as approved per label</description>
      <arm_group_label>Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects aged 21-65&#xD;
  &#xD;
            2. Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²&#xD;
  &#xD;
            3. History of at least one unsuccessful dietary effort to lose body weight&#xD;
  &#xD;
            4. Willing and able to participate in the study procedures&#xD;
  &#xD;
            5. Understand and voluntarily sign the informed consent&#xD;
  &#xD;
            6. Approved ESG candidate at True You Weight Loss&#xD;
  &#xD;
            7. Access to internet&#xD;
  &#xD;
            8. Reliable transportation to and from Cary, North Carolina surrounding area&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Younger than 21 years of age&#xD;
  &#xD;
            2. Older than 65 years of age&#xD;
  &#xD;
            3. Patients on any medications or supplements including those that may influence&#xD;
               cholecystokinin (CCK), glucose, growth hormone, insulin and/or somatostatin levels&#xD;
  &#xD;
            4. Milk and/or soy allergies&#xD;
  &#xD;
            5. History of any stomach manipulation (including repair of hiatal hernia)&#xD;
  &#xD;
            6. History of disordered eating&#xD;
  &#xD;
            7. Patients who do not give their consent to the enrollment in the study or are&#xD;
               incompetent, unconscious or unable to express their consent for any reason&#xD;
  &#xD;
            8. Hemoglobin A1c &gt; 7.0 or any patient with symptoms suggestive of gastroparesis or a&#xD;
               formal diagnosis of gastroparesis&#xD;
  &#xD;
            9. Patients taking the following medications known to impair gastric accommodation:&#xD;
               buspirone, mirtazapine&#xD;
  &#xD;
           10. Patients taking the following medications known to accelerate or impair gastric&#xD;
               emptying: Reglan (metoclopramide), Zelnorm (tegaserod), Motegrity (prucalopride),&#xD;
               erythromycin, Motilium (domperidone), opiates, anticholinergic agents&#xD;
  &#xD;
           11. Patients who are pregnant or who plan to become pregnant during study duration&#xD;
  &#xD;
           12. Use of non-steroidal anti-inflammatory medications without the ability to stop these&#xD;
               during study duration&#xD;
  &#xD;
           13. Patients on chronic anticoagulation&#xD;
  &#xD;
           14. History of functional gastrointestinal disorder, including functional dyspepsia,&#xD;
               irritable bowel syndrome, or other syndromes known to affect gastric sensorimotor&#xD;
               function.&#xD;
  &#xD;
           15. Concurrent use of weight loss medications.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chase Wooley, BS</last_name>
      <phone>(919) 336-4171</phone>
      <email>chase@trueyouweightloss.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christopher E McGowan, MD, MSCR</last_name>
      <email>drmcgowan@trueyouweightloss.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>True You Weight Loss</name>
        <address>
          <city>Cary</city>
          <state>North Carolina</state>
          <zip>27513</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Chase Wooley, BS</last_name>
        <phone>919-336-4171</phone>
        <email>Chase@TrueYouWeightLoss.com</email>
      </contact>
      <investigator>
        <last_name>Christopher E McGowan, MD, MSCR</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.trueyouweightloss.com</url>
      <description>Sponsor Site</description>
    </link>
    <reference>
      <citation>Fukunishi Y. [Electron microscopic findings in peripheral nerve lesions of nude mouse inoculated with M. leprae--perineural lesion]. Nihon Rai Gakkai Zasshi. 1985 Jul-Sep;54(3):82-7. doi: 10.5025/hansen1977.54.82. No abstract available. Japanese.</citation>
      <PMID>3915747</PMID>
    </reference>
    <reference>
      <citation>Cummings DE, Overduin J. Gastrointestinal regulation of food intake. J Clin Invest. 2007 Jan;117(1):13-23. doi: 10.1172/JCI30227.</citation>
      <PMID>17200702</PMID>
    </reference>
    <reference>
      <citation>Goitein D, Lederfein D, Tzioni R, Berkenstadt H, Venturero M, Rubin M. Mapping of ghrelin gene expression and cell distribution in the stomach of morbidly obese patients--a possible guide for efficient sleeve gastrectomy construction. Obes Surg. 2012 Apr;22(4):617-22. doi: 10.1007/s11695-011-0585-9.</citation>
      <PMID>22231739</PMID>
    </reference>
    <reference>
      <citation>Anderson B, Switzer NJ, Almamar A, Shi X, Birch DW, Karmali S. The impact of laparoscopic sleeve gastrectomy on plasma ghrelin levels: a systematic review. Obes Surg. 2013 Sep;23(9):1476-80. doi: 10.1007/s11695-013-0999-7.</citation>
      <PMID>23794092</PMID>
    </reference>
    <reference>
      <citation>McCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614.</citation>
      <PMID>31592891</PMID>
    </reference>
    <reference>
      <citation>Langer FB, Reza Hoda MA, Bohdjalian A, Felberbauer FX, Zacherl J, Wenzl E, Schindler K, Luger A, Ludvik B, Prager G. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg. 2005 Aug;15(7):1024-9. doi: 10.1381/0960892054621125.</citation>
      <PMID>16105401</PMID>
    </reference>
    <reference>
      <citation>Lopez-Nava G, Negi A, Bautista-Castano I, Rubio MA, Asokkumar R. Gut and Metabolic Hormones Changes After Endoscopic Sleeve Gastroplasty (ESG) Vs. Laparoscopic Sleeve Gastrectomy (LSG). Obes Surg. 2020 Jul;30(7):2642-2651. doi: 10.1007/s11695-020-04541-0.</citation>
      <PMID>32193741</PMID>
    </reference>
    <reference>
      <citation>Vijayvargiya P, Chedid V, Wang XJ, Atieh J, Maselli D, Burton DD, Clark MM, Acosta A, Camilleri M. Associations of gastric volumes, ingestive behavior, calorie and volume intake, and fullness in obesity. Am J Physiol Gastrointest Liver Physiol. 2020 Aug 1;319(2):G238-G244. doi: 10.1152/ajpgi.00140.2020. Epub 2020 Jul 6.</citation>
      <PMID>32628074</PMID>
    </reference>
    <reference>
      <citation>Fayad L, Oberbach A, Schweitzer M, Askin F, Voltaggio L, Larman T, Enderle M, Hahn H, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization (GMD): translation to a novel endoscopic metabolic therapy. Endosc Int Open. 2019 Dec;7(12):E1640-E1645. doi: 10.1055/a-0957-3067. Epub 2019 Nov 25.</citation>
      <PMID>31788546</PMID>
    </reference>
    <reference>
      <citation>Lopez Nava G, Arau RT, Asokkumar R, Maselli DB, Rapaka B, Matar R, Bautista I, Espinos Perez JC, Bilbao AM, Jaruvongvanich V, Vargas EJ, Storm AC, Neto MG, Abu Dayyeh BK. Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity. Clin Gastroenterol Hepatol. 2023 Jan;21(1):81-89.e4. doi: 10.1016/j.cgh.2022.04.019. Epub 2022 May 6.</citation>
      <PMID>35533995</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Weight Loss</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992103
  org study id: PS-002
  nct id: NCT05992103
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this research is to investigate the combined effects of fundic ablation (FA)
        and endoscopic sleeve gastroplasty on circulating plasma ghrelin, satiation, and total body
        weight loss, as well as the incidence of adverse events. This procedure will be carried out
        with the HybridAPC (ERBE Elektromedizin GmbH, Tübingen, Germany). The HybridAPC instrument
        creates an electric current to deliver a safe amount of thermal injury to a portion of the
        stomach known as the gastric fundus. This thermal injury will target a hormone called ghrelin
        which is the only known hormone linked to increasing appetite, calorie intake, and weight
        gain. This procedure is designed to target the bodily effects of appetite control and gastric
        sensory and motor functions which cause the feeling of fullness and satiation. When fundic
        mucosal ablation is paired with endoscopic sleeve gastroplasty (ESG), this combined
        investigational approach may lead to decreased fasting ghrelin levels, improved satiation,
        and greater total body weight loss than traditional ESG. This study will help determine if
        the combined impact of FA with ESG within the same endoscopic session should be made
        available to patients as part of a comprehensive weight loss strategy.
  Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure
        and mediated by multiple central and peripheral pathways that may serve as targets for
        therapeutic interventions. The endoscopic sleeve gastroplasty (ESG) is a per oral gastric
        remodeling technique that employs full-thickness suturing to imbricate the stomach along the
        greater curvature to achieve a restricted, sleeve-like configuration. While the ESG
        recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as
        robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major
        difference between ESG and LSG is that the former does not involve the gastric fundus. The
        proximal stomach, and the fundus in particular, produces ghrelin, the only known orexigenic
        hormone, which has been linked to increased calorie intake and weight gain. Studies have
        observed reduced levels of ghrelin along multiple timepoints following LSG, and this has been
        attributed to targeting of the fundus, as bariatric surgeries that did not involve the fundus
        did not see a decrease in circulating plasma ghrelin. In contrast, in a small comparative
        study of ESG and LSG, patients who had undergone ESG did not show any decrease in fasting
        ghrelin levels, 8 ostensibly due to fundic-sparing. In this study, the investigators propose
        to investigate the effects of fundic ablation (FA-ESG) on total body weight loss (TBWL) as
        well as the incidence of adverse events. Fundic ablation will be followed with ESG, to
        evaluate the combined impact of FA and ESG (FA-ESG). This study hypothesizes that the
        combined endoscopic intervention (FA-ESG) will result in significant weight loss while
        maintaining an acceptable safety profile
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Rate of Safety Complications
  time frame: Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
  description: Occurrence of Grade III - V complications according to the Clavien-Dindo classification
  measure: Rate of Adverse Events
  time frame: Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
  description: Occurrence of Adverse Events and Serious Adverse Events
  measure: Percent Change in Total Body Weight Loss (TBWL) from Baseline
  time frame: Week 1, Month 1, Month 2, Month 3, Month 4, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12
  description: Measure percent change in total body weight over time following FA-ESG. TBWL = pre-op weight - post op body weight. % TBWL is the fraction of body weight expressed in percentage term
  arm group label: Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty
  arm group type: Experimental
  description: Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session
  intervention type: Procedure
  intervention name: Fundic Ablation in Combination with Endoscopic Sleeve Gastroplasty
  description: Fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the treatment of adults with obesity
  arm group label: Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty
  intervention type: Device
  intervention name: Fundic Mucosal Ablation with ERBE HybridAPC
  description: Fundic mucosal ablation utilizing approved ERBE HybridAPC
  arm group label: Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty
  intervention type: Device
  intervention name: Apollo ESG
  description: Using only Apollo ESG as approved per label
  arm group label: Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chase Wooley, BS
  phone: (919) 336-4171
  email: chase@trueyouweightloss.com
  last name: Christopher E McGowan, MD, MSCR
  email: drmcgowan@trueyouweightloss.com
  facility: 
  contact: 
  investigator: 
  country: United States
  url: http://www.trueyouweightloss.com
  description: Sponsor Site
  citation: Fukunishi Y. [Electron microscopic findings in peripheral nerve lesions of nude mouse inoculated with M. leprae--perineural lesion]. Nihon Rai Gakkai Zasshi. 1985 Jul-Sep;54(3):82-7. doi: 10.5025/hansen1977.54.82. No abstract available. Japanese.
  PMID: 3915747
  citation: Cummings DE, Overduin J. Gastrointestinal regulation of food intake. J Clin Invest. 2007 Jan;117(1):13-23. doi: 10.1172/JCI30227.
  PMID: 17200702
  citation: Goitein D, Lederfein D, Tzioni R, Berkenstadt H, Venturero M, Rubin M. Mapping of ghrelin gene expression and cell distribution in the stomach of morbidly obese patients--a possible guide for efficient sleeve gastrectomy construction. Obes Surg. 2012 Apr;22(4):617-22. doi: 10.1007/s11695-011-0585-9.
  PMID: 22231739
  citation: Anderson B, Switzer NJ, Almamar A, Shi X, Birch DW, Karmali S. The impact of laparoscopic sleeve gastrectomy on plasma ghrelin levels: a systematic review. Obes Surg. 2013 Sep;23(9):1476-80. doi: 10.1007/s11695-013-0999-7.
  PMID: 23794092
  citation: McCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614.
  PMID: 31592891
  citation: Langer FB, Reza Hoda MA, Bohdjalian A, Felberbauer FX, Zacherl J, Wenzl E, Schindler K, Luger A, Ludvik B, Prager G. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg. 2005 Aug;15(7):1024-9. doi: 10.1381/0960892054621125.
  PMID: 16105401
  citation: Lopez-Nava G, Negi A, Bautista-Castano I, Rubio MA, Asokkumar R. Gut and Metabolic Hormones Changes After Endoscopic Sleeve Gastroplasty (ESG) Vs. Laparoscopic Sleeve Gastrectomy (LSG). Obes Surg. 2020 Jul;30(7):2642-2651. doi: 10.1007/s11695-020-04541-0.
  PMID: 32193741
  citation: Vijayvargiya P, Chedid V, Wang XJ, Atieh J, Maselli D, Burton DD, Clark MM, Acosta A, Camilleri M. Associations of gastric volumes, ingestive behavior, calorie and volume intake, and fullness in obesity. Am J Physiol Gastrointest Liver Physiol. 2020 Aug 1;319(2):G238-G244. doi: 10.1152/ajpgi.00140.2020. Epub 2020 Jul 6.
  PMID: 32628074
  citation: Fayad L, Oberbach A, Schweitzer M, Askin F, Voltaggio L, Larman T, Enderle M, Hahn H, Khashab MA, Kalloo AN, Kumbhari V. Gastric mucosal devitalization (GMD): translation to a novel endoscopic metabolic therapy. Endosc Int Open. 2019 Dec;7(12):E1640-E1645. doi: 10.1055/a-0957-3067. Epub 2019 Nov 25.
  PMID: 31788546
  citation: Lopez Nava G, Arau RT, Asokkumar R, Maselli DB, Rapaka B, Matar R, Bautista I, Espinos Perez JC, Bilbao AM, Jaruvongvanich V, Vargas EJ, Storm AC, Neto MG, Abu Dayyeh BK. Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity. Clin Gastroenterol Hepatol. 2023 Jan;21(1):81-89.e4. doi: 10.1016/j.cgh.2022.04.019. Epub 2022 May 6.
  PMID: 35533995
  responsible party type: Sponsor
  mesh term: Weight Loss