Trial results for a study evaluating combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) for obesity were posted on 2025-10-23. The trial reported a significant mean difference of 0.53 (p=0.01) in durability scores for the combined treatment compared to ESG alone.
Background
Obesity is a complex chronic disease associated with numerous health complications. Endoscopic Sleeve Gastroplasty (ESG) is an established minimally invasive procedure for weight loss, offering an alternative to traditional bariatric surgery. This study explored the potential benefits of combining ESG with Hybrid Argon Plasma Coagulation (HAPC) to enhance outcomes for individuals with obesity who have not achieved sustained weight loss through non-surgical programs. The aim was to assess the safety and effectiveness of this combined approach for weight loss and improving obesity-related co-morbidities.
Trial design
This completed study, designated as Phase NA, enrolled 45 participants with Obesity. The trial compared the safety and effectiveness of combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) against ESG alone. Participants had a BMI ≥ 30 and ≤40 kg/m² and had previously failed to achieve and maintain weight loss with a non-surgical program.
Key results
The trial reported several key measurements related to durability, assessed on a scale:
- Durability (Score on a scale):
- Control Group (ESG): Mean of 1.2 (Standard Deviation 0.1)
- Treatment Group (ESG + HAPC): Mean of 3.0 (Standard Deviation 0.12)
- Durability (Score on a scale):
- Control Group (ESG): Mean of 1.4 (Standard Deviation 0.7)
- Treatment Group (ESG + HAPC): Mean of 3.0 (Standard Deviation 0.0)
- Durability (Score on a scale):
- Control Group (ESG): Mean of 1.4 (Standard Deviation 0.7)
- Treatment Group (ESG + HAPC): Mean of 3.0 (Standard Deviation 0)
- Durability (Score on a scale):
- Control Group (ESG): Mean of 2.8 (Standard Deviation 0.4)
- Treatment Group (ESG + HAPC): Mean of 1.8 (Standard Deviation 0.7)
- Durability (Score on a scale):
- Control Group (ESG): Mean of 2.8 (Standard Deviation 0.4)
- Treatment Group (ESG + HAPC): Mean of 1.9 (Standard Deviation 0.7)
- Durability (Score on a scale):
- Control Group (ESG): Mean of 2.8 (Standard Deviation 0.4)
- Treatment Group (ESG + HAPC): Mean of 1.8 (Standard Deviation 0.6)
Key analyses further evaluated these findings:
- A t-test (2-sided) comparing scores from the proximal, mid, and distal stomach between groups found a Mean Difference (Final Values) of 0.53 (95.0% Confidence Interval: 0.31 to 0.74), with a p-value of 0.01.
- An ANCOVA analysis reported a Mean Difference (Final Values) of 19.125 (95.0% Confidence Interval: 19.125 to 19.125) with a p-value of 1.
- Further ANCOVA analyses yielded p-values of 0.757, 0.271, 0.29, and 0.72.
What this means
The results indicate that the combined approach of Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty may offer an advantage in certain durability measures for individuals with obesity. Specifically, a statistically significant mean difference of 0.53 (p=0.01) was observed in durability scores across different stomach regions when comparing the combined treatment to ESG alone. While some individual durability measurements showed higher mean scores in the treatment group, other analyses did not demonstrate significant differences. These findings suggest potential benefits for the combined procedure in enhancing durability, which could contribute to sustained weight loss and improved management of obesity-related co-morbidities.
Source
The information for this condition update was sourced from ClinicalTrials.gov, a public registry of clinical studies. The trial results for NCT05559866, titled "Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial", were posted on 2025-10-23 on clinicaltrials.gov.