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Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates (ESGiTXKidney)

Primary Purpose

Obesity, Morbid, End Stage Renal Disease, Kidney Transplantation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic Sleeve Gastroplasty (ESG)
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients (i.e., age between 18 and 70 years). BMI ≥ 35 kg/m²; Patients with chronic kidney disease (CKD) G4-G5 (glomerular filtration rate [GFR] <30ml/min/1.73 m2) who are expected to reach end-stage kidney disease (ESKD) at least 6 to 12 months before anticipated dialysis initiation (pre-emptive transplant candidates) or patients already on haemodialysis when medically stable and kidney failure deemed irreversible; Patients not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2); Signed informed consent. Exclusion Criteria: Patients on peritoneal dialysis Upper gastro-intestinal bleeding (gastric or oesophageal) in the previous six months; Ongoing or active malignancy during the last 5 years Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification; Previous stomach, oesophagus or duodenum surgery; Technical non-feasibility in the opinion of the endoscopist; Clinical signs of active infection; Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg); Active drugs or alcohol abuse; Pregnancy, lactation (desire to become pregnant during study duration); Enrolment in other clinical studies; Contraindication to general anaesthesia; Other conditions to exclude the subject in investigators opinion; Refusal to sign informed consent. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    kidney transplant candidates with obesity (BMI > 35 kg/m2)

    Arm Description

    Subjects with an indication to kidney transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2)

    Outcomes

    Primary Outcome Measures

    Kidney transplant list inclusion
    number of patients who achieve a BMI < 35 kg/m² within 12 months post-ESG, allowing them to be included in the kidney transplant list

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2023
    Last Updated
    July 20, 2023
    Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05917795
    Brief Title
    Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
    Acronym
    ESGiTXKidney
    Official Title
    Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2027 (Anticipated)
    Study Completion Date
    July 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects (≥35 kg/m2) with end stage renal disease who need of kidney transplantation to reduce their BMI below 35 in order to be inserted in the waiting list BMI. The main question[s] it aims to answer are: Is the procedure effective in reducing BMI to the target level in 12 months? Which is the effect on weight loss, quality of life and obesity-related comorbidities? Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Morbid, End Stage Renal Disease, Kidney Transplantation, Endoscopic Sleeve Gastroplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    kidney transplant candidates with obesity (BMI > 35 kg/m2)
    Arm Type
    Experimental
    Arm Description
    Subjects with an indication to kidney transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2)
    Intervention Type
    Procedure
    Intervention Name(s)
    Endoscopic Sleeve Gastroplasty (ESG)
    Intervention Description
    ESG will be performed under general anaesthesia with orotracheal intubation. The Endomina® suturing system (EndoTools Therapeutics S.A., Gosselies, Belgium) mounted on a single channel endoscope (GIF-H190/GIF-HQ190; Olympus Medical Systems Corp., Tokyo, Japan) will be used. This system allows to obtain full thickness gastric sutures through the gastric wall of the gastric body, leaving the antrum and the gastric fundus free. The ESG starts with the reduction of the gastric body, suturing from distal to proximal and starting from the notch of the angulus and ending at the level of the fundus. 4-8 full thickness stitches will be placed, with 2 passes per stitch. The final effect of ESG is the creation of a gastric tubule thus reducing the volume of the stomach. After the procedure, the final shape will be evaluated, to examine any gaps that would require additional closure, and to exclude bleedings and/or other complications.
    Primary Outcome Measure Information:
    Title
    Kidney transplant list inclusion
    Description
    number of patients who achieve a BMI < 35 kg/m² within 12 months post-ESG, allowing them to be included in the kidney transplant list
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients (i.e., age between 18 and 70 years). BMI ≥ 35 kg/m²; Patients with chronic kidney disease (CKD) G4-G5 (glomerular filtration rate [GFR] <30ml/min/1.73 m2) who are expected to reach end-stage kidney disease (ESKD) at least 6 to 12 months before anticipated dialysis initiation (pre-emptive transplant candidates) or patients already on haemodialysis when medically stable and kidney failure deemed irreversible; Patients not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2); Signed informed consent. Exclusion Criteria: Patients on peritoneal dialysis Upper gastro-intestinal bleeding (gastric or oesophageal) in the previous six months; Ongoing or active malignancy during the last 5 years Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification; Previous stomach, oesophagus or duodenum surgery; Technical non-feasibility in the opinion of the endoscopist; Clinical signs of active infection; Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg); Active drugs or alcohol abuse; Pregnancy, lactation (desire to become pregnant during study duration); Enrolment in other clinical studies; Contraindication to general anaesthesia; Other conditions to exclude the subject in investigators opinion; Refusal to sign informed consent. -

    12. IPD Sharing Statement

    Learn more about this trial

    Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates

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