Breakthrough in Obesity Treatment: Gastric Bypass Stent System NMPA Review Unveiled
In a significant stride towards combating obesity, a landmark clinical trial has culminated in the release of the NMPA Review Report for the innovative Gastric Bypass Stent System. This pioneering study was meticulously designed as a prospective, multicenter, randomized, parallel, placebo-controlled, superiority clinical trial, engaging some of the most prestigious clinical institutions across China.
The clinical trial saw participation from seven leading hospitals, including Beijing Friendship Hospital affiliated with Capital Medical University and Drum Tower Hospital affiliated with Nanjing University Medical School, among others. Initially set to enroll 100 subjects evenly split between trial and control groups, the study successfully registered 99 participants. The comprehensive analysis encompassed 98 subjects in the Full Analysis Set (FAS), 81 in the Per Protocol Set (PPS), and 98 in the Safety Set (SS), ensuring the trial's robustness and reliability.
The primary goal was to measure the proportion of subjects achieving more than a 5% weight reduction at 3 months post-enrollment, alongside the percentage of excess weight loss (EWL%). Secondary objectives included assessing changes in waist circumference and evaluating the device's effectiveness and safety within the trial group.
Results were groundbreaking. In the FAS set, 69.39% of the trial group achieved over a 5% reduction in weight three months after enrollment, dramatically outperforming the 30.61% in the control group. This marked difference of 38.78% firmly exceeded the superiority margin set at 10%, with the 95% confidence interval ranging from 20.53% to 57.03%. Similar superiority was confirmed in the PPS set, with 76.19% of the trial group reaching the weight loss goal compared to 35.90% of the control group, further validating the device's efficacy.
TX Medical boasts extensive experience in clinical trials for innovative medical devices, underscoring its dedication to pioneering advancements in medical technology. This expertise not only paves the way for groundbreaking treatment options but also marks significant progress in the development of non-surgical approaches to healthcare challenges.
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