Pilot study of temporary controllable gastric pseudobezoars for dynamic non-invasive gastric volume reduction

Abstract

Invasive surgical procedures for gastric volume reduction or bypass have been considered the most effective approach to sustainable long-term weight reduction. However, non-invasive techniques for dynamic volume reduction from inside the stomach are lacking. The aim of this study was to propose temporary, permeable, controllable pseudobezoars for non-invasive, long-term sustainable gastric volume reduction and to test them in pilot human studies. Permeable sac-like carriers made from biocompatible and biodegradable material were filled with expandable superabsorbent fiber and polymer granules. The implements were designed to prevent the expulsion of the pseudobezoars through the pylorus for a controlled time period. The pseudobezoars were administered transorally to two human patients (2M, 78.9 kg/174 cm, girth 88.1 cm, and 89.7 kg/175, girth 95.2 cm). Body weight dynamics, girth, level of satiety, stools, bowel regularity and notable side effects were monitored in three distinct 1 month periods: baseline, therapy and washout. Sonographic verification of the presence of pseudobezoars in the stomachs of both subjects was performed at the end of the therapy month and was repeated at the end of the washout period to examine the clearance of the implements. During the therapy month, both individuals exhibited significant weight and girth reduction (p < 0.05), and substantially increased satiety levels. The patients retained their bowel regularity and did not report any notable side effects. The temporary pseudobezoars were clearly noticeable sonographically in both patients at the end of the therapy month and cleared after its discontinuation. Controllable temporary pseudobezoars were designed and tested in pilot studies.

Utilization of Temporary Controllable Intragastric Pseudobezoars for the Treatment of Obesity

“…A novel temporary, controllable pseudobezoar weight loss concept was formulated recently [15][16][17][18]19••, 20, 21, 22••]. It propounds artificial, temporary pseudobezoars that are intended to combine the noninvasiveness of the conservative therapies with the long-term sustainable weight loss effect of the invasive antiobesity approaches.…”

“…The first pilot human study [19,20] involved two overweight healthy male adults (2 M, BW084.3±7.6 kg, body mass index (BMI)027.7±2.3 kg/m 2 , HC091.7±5.0 cm). Significant weight loss and girth reduction during the therapy period were registered and the final values were BW079.7± 6.0 kg and HC088.3 ± 3.7 cm.…”

Gastric Electrical Stimulation for the Treatment of Obesity: From Entrainment to Bezoars—A Functional Review

“…The recently proposed temporary controllable pseudobezoar concept [52–58] can be considered a bridge between the two main obesity treatment streams—starting as a completely conservative, noninvasive approach—this therapy literally grows in the human stomach to an intragastric bezoar-based treatment, with the capability to be discontinued in a controllable noninvasive fashion. Attempts have been made to combine bezoar-based therapy with gastric electrical stimulation, but the evidence of efficient electrical stimulation from the mucosal side of the gastrointestinal tract remains anecdotal [52–55].…”

“…A novel temporary, controllable pseudobezoar weight loss concept was formulated recently [58, 80, 81]. It proposes the utilization of artificial, temporary pseudobezoars which is intended to combine the noninvasiveness of the conservative therapies with the long-term sustainable weight loss effect of the invasive antiobesity approaches.…”

“…Their regular intake reduces gastric volume similarly to the way intragastric balloons do, thus invoking constant feeling of satiety. Pilot and blind, placebo-controlled chronic human studies [58, 80, 81] have confirmed the viability of pseudobezoar approach as an alternative, noninvasive, safe, and effective weight control method. A 30-day therapy was reported, resulting in increased satiety, significant weight reduction, and insignificant side effects.…”