MULTICENTER PILOT RANDOMIZED CONTROLLED TRIAL EVALUATING THE EFFICACY OF THE PRIMARY OBESITY SURGERY ENDOLUMINAL (POSE2.0) PROCEDURE IN OBESITY MANAGEMENT

Background and aims: The Primary Obesity Surgery Endoluminal 2.0 (POSE2.0) is an endoscopic gastric remodeling procedure that utilizes an incisionless operating platform (IOP, San Clemente, CA) to remodel the stomach and alter appetite (Figure 1). Its core innovation involves creating full-thickness gastric plications using suture anchor pairs constructed of nitinol baskets, enhancing the intervention's durability. Our study (NCT03837691) is the first randomized controlled trial to assess the technical feasibility, safety, efficacy of POSE2.0.

Methods: 35 patients with obesity were randomized in a 5:2 open-label fashion to either the POSE2.0 procedure with moderate-intensity lifestyle modification (POSE2.0) or lifestyle modification alone (LM) at 4 US Academic Centers. The primary outcomes were percentage of total body weight loss (%TBWL) at 12 months and the incidence of adverse events. Secondary outcomes included the presence of plications on follow-up endoscopy at 12 months and the impact on the intervention on gastric emptying assessed using the 13C-Spirulina Gastric Emptying Breath Test (GEBT, Cairn Diagnostics, Brentwood, TN). Modified intent-to-treat (mITT) and Per Protocol (PP) analyses were performed.

Results: Demographic data are detailed in Table 1. At 12 months, the POSE2.0 group exhibited significant total body weight loss (TBWL) of 12.8 ± 7.55%, surpassing the 2.5 ± 11.34% in the LS group, as per modified intention-to-treat (mITT) analysis (p=0.006). On a per-protocol basis, TBWL in the POSE2.0 group reached 14.0 ± 7.64%. Notably, no serious adverse events related to the device or procedure were observed. Endoscopic durability assessments at 12 months confirmed the integrity of all plications and the gastroplasty construct, with no pathological findings. Gastric emptying, measured by T50 values, showed a mild delay of 19.5 ± 42.85 and 19.6 ± 31.68 minutes at 2 and 6 months, respectively, with no correlation to weight loss (r2=-0.04, p=0.56). The Gastroparesis Cardinal Symptom Index (GCSI) revealed no increase in nausea, retching, vomiting, or bloating at 1, 2, 6, and 12 months, while parameters of fullness improved consistently across these time points.

Conclusions: POSE2.0 demonstrates safety, efficacy, and durability as an endoscopic bariatric therapy. This intervention aligns with the evolving paradigm in minimally invasive obesity management, highlighting its role in modulating appetite-related mechanisms.