Background

Emerging weight-loss medications pave the way for non-invasive obesity treatment, but sustained benefits require integration of mechanisms like dietary monitoring, mechanical and hormonal restrictions, and malabsorption. Reversible, minimally invasive medical devices are advancing to implement this multimodal strategy, reflecting a comprehensive approach for enduring effectiveness in obesity management.OBJECTIVESThis retrospective study aims to assess safety, effectiveness, metabolic and hormonal impact, as well as satiety and eating behaviors effects of B-ClampTM (MID, Dardilly), a reversible vertical clamp reducing gastric volume.SETTINGUniversity Hospital.

Methods

Our study (NCT01129297) included 42 patients who underwent B-ClampTM insertion for severe obesity (BMI>35 and diabetes or BMI>40 kg/m2) following a minimum of 6 months of specialized nutritional preparation (2019-2022). We investigated the mechanisms of diabetes mellitus during standardized meals test (SMT), where Insulin, GLP-1, and Ghrelin levels were measured. We assessed satiety (DEBQ), food intake, and quality of life (QoL, SF36).

Results

Forty-two patients (BMI: 41.6+-5.6) underwent laparoscopic B-ClampTM placement without severe adverse events. The one-year systematic endoscopy revealed one case of asymptomatic gastric erosion. Three years post-surgery, weight loss in addition to that already achieved during nutritional preparation was 14% (% Total Weight Loss). Food tolerance was excellent, as 93% of patients reporting no vomiting. SMT results demonstrated increased GLP-1 secretion at 60 minutes (p<0.01), but no discernible impact on Ghrelin secretion (p=0.34). There was a reduction in food intake, an enhancement in QoL, and a positive shift in DEBQ (p<0.01).

Conclusions

ClampTM seems to be a secure, well-tolerated, and effective restrictive procedure.