Aims EndoZip is a fully automated endoscopic suturing device designed to reduce gastric
volume for obesity treatment, minimizing the operator-dependence for endoscopic gastroplasty.
A recent multicenter clinical trial showed that the device is safe and effective for
the treatment of class I and II obesity1. In this study, we aim to assess the efficacy and safety of EndoZip to treat patients
with obesity-related comorbidities.
Methods This an interim analysis of a prospective, single-arm, open-label, clinical trial
including patients with BMI of 30-42g/m2 and hypertension and/or type 2 diabetes mellitus (T2DM) who failed non-invasive weight-loss
therapies and deemed suitable for bariatric endoscopy according to the multidisciplinary
team. We report percentage of total body weight loss (%TBWL), changes in Hb1AC, changes
in ambulatory blood pressure monitor (ABPM) following automatic endoscopic procedure.
Incidence of adverse events was also recorded [1]. A correlation between weight loss, categorized as “%TBWL<5%=Unchanged”, “%TBWL
5%-10%=modest Weight Loss “, and “%TBWL>10%=significant weight loss”, and changes
in comorbidities have been explored by using Chi-Square test.
Results Twenty patients (80% female, mean age 51.9±9.6, mean BMI 34.8±3.1 kg/m2) were enrolled at a single tertiary center. Five patients (25%) had both hypertension
and T2DM, eleven (55%) had only hypertension, and four (20%) had only T2DM. One patient
with hypertension was lost to follow-up. At 6-months, the mean%TBWL was 11.9%±5.0.
Among the patients with hypertension, 6/15 (40.0%) showed an improvement in ABPM values,
7/15 (46.7%) showed no change, and in 2/15 (13.3%) cases, there was a worsening of
ABPM values. In these latter two cases, the patients had discontinued an antihypertensive
medication. 7/9 (77.8%) patients with T2DM showed an improvement of Hb1AC (range Δ
0.5-2.5) and 2/9 (22.2%) showed no variation. No correlation between weight loss and
ABPM changes (P=0.196) and Hb1AC changes (P=0.571) were observed. One moderate adverse
event occurred, namely a bleeding that was effectively managed by endoscopic hemostasis.
Conclusions Based on these preliminary results, automatic endoscopic gastroplasty seems to be
safe and promising for the treatment of obesity and associated comorbidities such
as hypertension and T2DM. While a formal correlation could not be established due
to the limited sample size, a strong trend of improvement in T2DM outcomes was observed.
