- Data show a strong correlation in the duration of gastric contractility measured by means of the VIPUN GMS and manometry (golden standard) technique.
- Data show that the contraction frequency automatically detected by the VIPUN GMS, is strongly correlated with that observed by expert gastroenterologists on manometry recordings.
- Data show that the VIPUN GMS can be used to identify hallmarks of gastrointestinal motility, such as the MMC cycle and postprandial accommodation reflex.
Mechelen, Belgium, June 5, 2023 – VIPUN Medical, a company engaged in the development of innovate nutrition devices today announced positive clinical study results from LOTUS, a prospective, interventional, single-arm, monocentric, investigation in healthy adult humans designed to validate the VIPUN GMS as a gastric motility monitoring system.
The primary hypothesis, that the duration of gastric contractility measured by means of the VIPUN GMS and manometry (golden standard technique) are strongly correlated, was confirmed, both at the level of 10-min periods (r = 0.92, p < 0.001) and at subject level (ρ = 0.96, p < 0.001). A strong correlation was defined up front as a coefficient ≥ 0.7.
The secondary hypothesis, that the contraction frequency observed by expert gastro-enterologists on manometry is strongly correlated with the contraction frequency automatically detected by the VIPUN GMS, was confirmed, both the level of 10-min periods (r = 0.68, p < 0.0001) and at subject-level (ρ = 0.87, p = 0.001).
Expert gastroenterologists agreed on the presence/absence of hallmarks of normal gastric motility on both technologies. The intra-reader agreement was on average 84.6% for the identification of a MMC cycle and 76.2% for the identification of the accommodation reflex. These results indicate that both technologies allow a similar interpretation.