Automatic Endoscopic Gastroplasty for Obesity Comorbidities, with Valerio Pontecorvi, MD

New research is shedding light on the utility of EndoZipTM, a fully automated endoscopic suturing device designed to reduce gastric volume for obesity treatment, for treating patients with obesity-related comorbidities.1

The data were presented at Digestive Disease Week (DDW) 2025 by Valerio Pontecorvi, MD, a digestive system disease specialist at Gemelli University Hospital, and highlight the safety and efficacy of automatic endoscopic gastroplasty for the treatment of obesity and associated comorbidities such as hypertension and type 2 diabetes.1

“The EndoZip is the first fully automatic and robotic suturing device,” Pontecorvi explained to HCPLive, describing key differences from other currently available devices.

In a recent multicenter study, use of EndoZip resulted in an average total body weight loss of 13.21% at 12 months with additional improvements observed in metabolic health indicators such as reductions in waist circumference, HbA1C, and alanine aminotransferase levels. In addition, significant quality of life improvements were also reported, with technical success of the procedure achieved in all patients and a low incidence of reported adverse events.2

Now, the system’s efficacy and safety of EndoZip for treating patients with obesity-related comorbidities is being explored in a prospective, single-arm, open-label, clinical trial. It enrolled patients with BMI of 30-42g/m2 and hypertension and/or type 2 diabetes mellitus who failed non invasive weight-loss therapies and were deemed suitable for bariatric endoscopy by a multidisciplinary team.1

The findings presented at DDW were part of an interim analysis of percentage of total body weight loss, changes in Hb1AC, changes in ambulatory blood pressure monitor, and the incidence of adverse events in a cohort of 20 patients seen at a single tertiary center.1

Among the cohort, the majority of patients were female (80%) with a mean age of 51.9±9.6 years and a mean BMI of 34.8±3.1 kg/m2. Investigators noted 5 (25%) patients had both hypertension and type 2 diabetes, 11 (55%) had only hypertension, and 4 (20%) had only type 2 diabetes.1

At 6 months, the mean percentage of total body weight loss was 11.9% ±5.0. Among the patients with hypertension, 6 (40.0%) showed an improvement in ambulatory blood pressure monitor values and 7 (46.7%) showed no change. In 2 (13.3%) cases, investigators observed a worsening of ambulatory blood pressure monitor values but noted the patients had discontinued an antihypertensive medication.1

In patients with type 2 diabetes, 7 (77.8%) showed an improvement of Hb1AC (range 0.5-2.5) and 2 (22.2%) showed no variation. Investigators did not observe any correlation between weight loss and ABPM changes (P = .196) and Hb1AC changes (P = .571). A single moderate adverse event was noted, which was a bleeding that was effectively managed by endoscopic hemostasis.1

“I think that the next step will be to see all the data from all the centers,” Pontecorvi said, acknowledging that the data presented at DDW were from just one of multiple centers involved in the full study. “We need to complete, to observe, and to analyze all the data as the first step. Then, we need to enlarge the population of study. The more studies, the better the data are.”

References

1. Matteo MV, Bove V, De Siena M, et al. AUTOMATIC ENDOSCOPIC GASTROPLASTY FOR THE TREATMENT OF OBESITY AND ASSOCIATED COMORBIDITIES: AN INTERIM ANALYSIS OF A PROSPECTIVE CLINICAL TRIAL

2. PRNewswire. Nitinotes Announces Multicenter Study on EndoZip Endoscopic Suturing System for Obesity Treatment Published in GIE Journal. September 27, 2024. Accessed May 3, 2025. https://www.prnewswire.com/news-releases/nitinotes-announces-multicenter-study-on-endozip-endoscopic-suturing-system-for-obesity-treatment-published-in-gie-journal-302261153.html