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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT05917795
Status
Recruiting
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Conditions

  • End Stage Renal Disease
  • Endoscopic Sleeve Gastroplasty
  • Kidney Transplantation
  • Obesity, Morbid

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic Sleeve Gastroplasty (ESG) — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Jun 26, 2023
Start date
Sep 24, 2023
Status verified
Jun 2023
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Kidney transplant list inclusion [ Time Frame: 12 months ]

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