<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/NCT03255005</url>
  </required_header>
  <id_info>
    <org_study_id>P2017/401</org_study_id>
    <nct_id>NCT03255005</nct_id>
  </id_info>
  <brief_title>Endomina Controlled Study</brief_title>
  <official_title>A Controlled Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) as an Aid for Endoscopic Gastric Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasme 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>
      The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty&#xD;
      (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular&#xD;
      by the incidence of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a&#xD;
      delayed treatment control group (diet alone; crossover at 6 months) with a treatment group&#xD;
      (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgery is currently the only effective treatment for morbid obesity and can be divided into&#xD;
      restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary&#xD;
      pancreatic deviation and duodenal switch) or a combination of both (RYGBP).&#xD;
&#xD;
      This latter technique is the most common and most effective surgical procedure performed&#xD;
      worldwide and has been processed to be an effective treatment of morbid obesity and its&#xD;
      complications, achieving excess weight loss of 65 to 80 %; 1-2 years after surgery.&#xD;
&#xD;
      Vertical gastric plication is a novel surgical approach for reducing the stomach capacity.&#xD;
      Anterior surface plication and greater curvature plication are variations of vertical gastric&#xD;
      plication that reduce the gastric capacity through infolding of the anterior surface or&#xD;
      greater curvature of the stomach, respectively. These approaches have been tested, with&#xD;
      positive results.&#xD;
&#xD;
      A transoral or endoluminal approach (i.e. a procedure that requires no incision, because&#xD;
      access is granted through the mouth) offers the potential for additional benefit to the&#xD;
      patient, because the procedures continue to become more and more minimally invasive.&#xD;
&#xD;
      Advances in endoluminal devices are now allowing clinicians the ability to begin exploring&#xD;
      bariatric procedures performed via flexible endoscopy. Although these procedures may not be&#xD;
      as effective as their surgical counterparts, these less-invasive options may relieve patients&#xD;
      of the significant risks associated with surgery and might become part of the armamentarium&#xD;
      of obesity management.&#xD;
&#xD;
      Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that may be&#xD;
      attached to an endoscope inside the body and allows remote actuation of the device during a&#xD;
      peroral intervention. It offers the possibilities of making transoral full thickness tissue&#xD;
      apposition and may allow performing, via a transoral route, large plications with tight&#xD;
      serosa to serosa apposition.&#xD;
&#xD;
      After a first trial on pigs (safety), a second trial on human patients was performed. This&#xD;
      trial included 11 patients treated with the same technique. There were no complications and&#xD;
      the short term results were encouraging with 41% EWL at 6 month.&#xD;
&#xD;
      A multicentric trial NCT02582229 entitled: &quot; A Prospective Study to Evaluate the Efficacy of&#xD;
      an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction. &quot; is&#xD;
      ongoing and inclusion of patients ended in December 2016 with a total of 51 patients included&#xD;
      in 3 European centers. Early results of the trial had showed that dietician follow-up is an&#xD;
      important part of the success. During that time implementation of the procedure had been&#xD;
      done.&#xD;
&#xD;
      The aim of this trial is to compare a control group (diet alone) with a treatment group&#xD;
      (Endomina procedure plus diet).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">March 26, 2020</completion_date>
  <primary_completion_date type="Actual">March 26, 2020</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Group A: treatment J0 + Diet 1 year Group B: Diet 6 months - Treatment - Diet 1 year</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of all Adverse Device Effects</measure>
    <time_frame>one year from procedure</time_frame>
    <description>Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>one year from procedure</time_frame>
    <description>total weight loss and excess weight loss</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight loss at 6 months</measure>
    <time_frame>at 6 months after the procedure (treatment group)</time_frame>
    <description>comparison between diet and treatment group at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>More than 15% weight loss</measure>
    <time_frame>one year from procedure</time_frame>
    <description>Proportion of patients in the Endomina Group with a loss of weight of more than 15%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>one year from procedure</time_frame>
    <description>SF36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TBWL</measure>
    <time_frame>one year from procedure</time_frame>
    <description>Mean % total body weight loss (%TBWL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight and height</measure>
    <time_frame>one year from procedure</time_frame>
    <description>To calculate the body mass index (BMI)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controled group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endomina</intervention_name>
    <description>Endoscopic sleeve reduction</description>
    <arm_group_label>Controled group</arm_group_label>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diet</intervention_name>
    <description>Multidisciplinary follow-up</description>
    <arm_group_label>Controled group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18-65 years;&#xD;
&#xD;
          2. Class I or class II obesity (i.e. BMI between 30 to 40 kg/m²);&#xD;
&#xD;
          3. Must be able to comply with all study requirements for the duration of the study as&#xD;
             outlined in the protocol. This includes complying with the visit schedule as well as&#xD;
             study specific procedures such as: clinical assessment, endoscopy, radiography, as&#xD;
             well as laboratory investigations;&#xD;
&#xD;
          4. Must be able to understand and be willing to provide written informed consent;&#xD;
&#xD;
          5. Must live within 75 km of the treatment site;&#xD;
&#xD;
          6. Had followed the bariatric multidisciplinary workup (blood analyses, dietician,&#xD;
             psychologist and doctor appointments).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Achalasia and any other esophageal motility disorders;&#xD;
&#xD;
          2. Severe esophagitis;&#xD;
&#xD;
          3. Gastro-duodenal ulcer;&#xD;
&#xD;
          4. Heart diseases: unstable angina, myocardial infarction within the past year, or heart&#xD;
             disease classified within the New York Heart Association's Class III or IV functional&#xD;
             capacity;&#xD;
&#xD;
          5. Hypertension: uncontrolled hypertension during last 3 months;&#xD;
&#xD;
          6. Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c &gt; 10%);&#xD;
&#xD;
          7. TBWL &gt;5% over the last 6 months;&#xD;
&#xD;
          8. Severe renal, hepatic, pulmonary disease or cancer;&#xD;
&#xD;
          9. GI stenosis or obstruction;&#xD;
&#xD;
         10. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;&#xD;
&#xD;
         11. Previous bariatric surgery, balloon or other endoscopic obesity-related therapy;&#xD;
&#xD;
         12. Anticoagulant therapy;&#xD;
&#xD;
         13. Impending gastric surgery 60 days post intervention;&#xD;
&#xD;
         14. Currently participating in other study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gastroenterology Department Erasme Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHM Hopital Marseille Nord Hepato-Gastroentérologie et Oncologie Digestive</name>
      <address>
        <city>Marseille</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee; Abu Dayyeh BK, Kumar N, Edmundowicz SA, Jonnalagadda S, Larsen M, Sullivan S, Thompson CC, Banerjee S. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015 Sep;82(3):425-38.e5. doi: 10.1016/j.gie.2015.03.1964. Epub 2015 Jul 29.</citation>
    <PMID>26232362</PMID>
  </results_reference>
  <results_reference>
    <citation>Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.</citation>
    <PMID>18392907</PMID>
  </results_reference>
  <results_reference>
    <citation>Menchaca HJ, Harris JL, Thompson SE, Mootoo M, Michalek VN, Buchwald H. Gastric plication: preclinical study of durability of serosa-to-serosa apposition. Surg Obes Relat Dis. 2011 Jan-Feb;7(1):8-14. doi: 10.1016/j.soard.2010.11.002. Epub 2010 Nov 12.</citation>
    <PMID>21255733</PMID>
  </results_reference>
  <results_reference>
    <citation>Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.</citation>
    <PMID>18355825</PMID>
  </results_reference>
  <results_reference>
    <citation>Paxton JH, Matthews JB. The cost effectiveness of laparoscopic versus open gastric bypass surgery. Obes Surg. 2005 Jan;15(1):24-34. doi: 10.1381/0960892052993477.</citation>
    <PMID>15760496</PMID>
  </results_reference>
  <results_reference>
    <citation>Huberty V, Ibrahim M, Hiernaux M, Chau A, Dugardeyn S, Deviere J. Safety and feasibility of an endoluminal-suturing device for endoscopic gastric reduction (with video). Gastrointest Endosc. 2017 Apr;85(4):833-837. doi: 10.1016/j.gie.2016.08.007. Epub 2016 Aug 22.</citation>
    <PMID>27562938</PMID>
  </results_reference>
  <results_reference>
    <citation>ASGE Bariatric Endoscopy Task Force; ASGE Technology Committee; Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, Banerjee S. Endoscopic bariatric therapies. Gastrointest Endosc. 2015 May;81(5):1073-86. doi: 10.1016/j.gie.2015.02.023. Epub 2015 Mar 28. No abstract available.</citation>
    <PMID>25828245</PMID>
  </results_reference>
  <results_reference>
    <citation>ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy; Ginsberg GG, Chand B, Cote GA, Dallal RM, Edmundowicz SA, Nguyen NT, Pryor A, Thompson CC. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011 Nov;74(5):943-53. doi: 10.1016/j.gie.2011.08.053. No abstract available.</citation>
    <PMID>22032311</PMID>
  </results_reference>
  <results_reference>
    <citation>Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724. Erratum In: JAMA. 2005 Apr 13;293(14):1728.</citation>
    <PMID>15479938</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>endoscopy</keyword>
  <keyword>endoscopic sleeve gastroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT03255005
org study id: P2017/401
nct id: NCT03255005
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this trial is to evaluate the efficacy of an endoluminal vertical gastroplasty
      (EVG) using an endoluminal-suturing device. Safety will also be characterized, in particular
      by the incidence of all Adverse Device Effects (ADEs). A secondary endpoint is to compare a
      delayed treatment control group (diet alone; crossover at 6 months) with a treatment group
      (EVG plus diet). Other secondary endpoints include improvements in other obesity measures.
Surgery is currently the only effective treatment for morbid obesity and can be divided into
      restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary
      pancreatic deviation and duodenal switch) or a combination of both (RYGBP).

      This latter technique is the most common and most effective surgical procedure performed
      worldwide and has been processed to be an effective treatment of morbid obesity and its
      complications, achieving excess weight loss of 65 to 80 %; 1-2 years after surgery.

      Vertical gastric plication is a novel surgical approach for reducing the stomach capacity.
      Anterior surface plication and greater curvature plication are variations of vertical gastric
      plication that reduce the gastric capacity through infolding of the anterior surface or
      greater curvature of the stomach, respectively. These approaches have been tested, with
      positive results.

      A transoral or endoluminal approach (i.e. a procedure that requires no incision, because
      access is granted through the mouth) offers the potential for additional benefit to the
      patient, because the procedures continue to become more and more minimally invasive.

      Advances in endoluminal devices are now allowing clinicians the ability to begin exploring
      bariatric procedures performed via flexible endoscopy. Although these procedures may not be
      as effective as their surgical counterparts, these less-invasive options may relieve patients
      of the significant risks associated with surgery and might become part of the armamentarium
      of obesity management.

      Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that may be
      attached to an endoscope inside the body and allows remote actuation of the device during a
      peroral intervention. It offers the possibilities of making transoral full thickness tissue
      apposition and may allow performing, via a transoral route, large plications with tight
      serosa to serosa apposition.

      After a first trial on pigs (safety), a second trial on human patients was performed. This
      trial included 11 patients treated with the same technique. There were no complications and
      the short term results were encouraging with 41% EWL at 6 month.

      A multicentric trial NCT02582229 entitled: " A Prospective Study to Evaluate the Efficacy of
      an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Gastric Reduction. " is
      ongoing and inclusion of patients ended in December 2016 with a total of 51 patients included
      in 3 European centers. Early results of the trial had showed that dietician follow-up is an
      important part of the success. During that time implementation of the procedure had been
      done.

      The aim of this trial is to compare a control group (diet alone) with a treatment group
      (Endomina procedure plus diet).
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Group A: treatment J0 + Diet 1 year Group B: Diet 6 months - Treatment - Diet 1 year
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of all Adverse Device Effects
time frame: one year from procedure
description: Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.
measure: Weight loss
time frame: one year from procedure
description: total weight loss and excess weight loss
measure: Weight loss at 6 months
time frame: at 6 months after the procedure (treatment group)
description: comparison between diet and treatment group at 6 months
measure: More than 15% weight loss
time frame: one year from procedure
description: Proportion of patients in the Endomina Group with a loss of weight of more than 15%
measure: Quality of life
time frame: one year from procedure
description: SF36
measure: TBWL
time frame: one year from procedure
description: Mean % total body weight loss (%TBWL)
measure: Weight and height
time frame: one year from procedure
description: To calculate the body mass index (BMI)
arm group label: Treatment group
arm group type: Active Comparator
description: Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year
arm group label: Controled group
arm group type: Active Comparator
description: Diet for 6 months then Endoscopic sleeve gastroplasty (Endomina) with multidisciplinary follow-up for 1 year
intervention type: Device
intervention name: Endomina
description: Endoscopic sleeve reduction
arm group label: Controled group
arm group label: Treatment group
intervention type: Behavioral
intervention name: Diet
description: Multidisciplinary follow-up
arm group label: Controled group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: Belgium
country: France
citation: ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee; Abu Dayyeh BK, Kumar N, Edmundowicz SA, Jonnalagadda S, Larsen M, Sullivan S, Thompson CC, Banerjee S. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015 Sep;82(3):425-38.e5. doi: 10.1016/j.gie.2015.03.1964. Epub 2015 Jul 29.
PMID: 26232362
citation: Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.
PMID: 18392907
citation: Menchaca HJ, Harris JL, Thompson SE, Mootoo M, Michalek VN, Buchwald H. Gastric plication: preclinical study of durability of serosa-to-serosa apposition. Surg Obes Relat Dis. 2011 Jan-Feb;7(1):8-14. doi: 10.1016/j.soard.2010.11.002. Epub 2010 Nov 12.
PMID: 21255733
citation: Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.
PMID: 18355825
citation: Paxton JH, Matthews JB. The cost effectiveness of laparoscopic versus open gastric bypass surgery. Obes Surg. 2005 Jan;15(1):24-34. doi: 10.1381/0960892052993477.
PMID: 15760496
citation: Huberty V, Ibrahim M, Hiernaux M, Chau A, Dugardeyn S, Deviere J. Safety and feasibility of an endoluminal-suturing device for endoscopic gastric reduction (with video). Gastrointest Endosc. 2017 Apr;85(4):833-837. doi: 10.1016/j.gie.2016.08.007. Epub 2016 Aug 22.
PMID: 27562938
citation: ASGE Bariatric Endoscopy Task Force; ASGE Technology Committee; Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, Kumar N, Larsen M, Sullivan S, Thompson CC, Banerjee S. Endoscopic bariatric therapies. Gastrointest Endosc. 2015 May;81(5):1073-86. doi: 10.1016/j.gie.2015.02.023. Epub 2015 Mar 28. No abstract available.
PMID: 25828245
citation: ASGE/ASMBS Task Force on Endoscopic Bariatric Therapy; Ginsberg GG, Chand B, Cote GA, Dallal RM, Edmundowicz SA, Nguyen NT, Pryor A, Thompson CC. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011 Nov;74(5):943-53. doi: 10.1016/j.gie.2011.08.053. No abstract available.
PMID: 22032311
citation: Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724. Erratum In: JAMA. 2005 Apr 13;293(14):1728.
PMID: 15479938
responsible party type: Sponsor
mesh term: Obesity