A Single-center Randomized Controlled Trial Evaluating Whether Adding Fundal Mucosal Ablation (FMA) to Standard Endoscopic Sleeve Gastroplasty (ESG) Leads to Greater Weight Loss, Improved Obesity-related Comorbidities, and Better Metabolic and Hormonal Outcomes Compared With ESG Alone in Adults With Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Percentage Change in Total Body Weight (%TBWL) from baseline to 1 month
研究概览
简要总结
The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. ESG reduces stomach volume through endoscopic suturing, while FMA uses Hybrid Argon Plasma Coagulation to ablate ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and improving satiety. Because previous ESG with FMA studies were small and single-arm, this trial is designed to provide comparative evidence against ESG alone.
Eligible adults aged 18 years or older with a BMI of at least 30 kg/m² and a history of unsuccessful weight-loss attempts will be enrolled. Participants will be randomized on the procedure day to either ESG with FMA or standard ESG alone. The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. ESG reduces stomach volume through endoscopic suturing, while FMA uses Hybrid Argon Plasma Coagulation to ablate ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and improving satiety. Because previous ESG with FMA studies were small and single-arm, this trial is designed to provide comparative evidence against ESG alone.
Eligible adults aged 18 years or older with a BMI of at least 30 kg/m² and a history of unsuccessful weight-loss attempts will be enrolled. Participants will be randomized 1:1 on the procedure day to either ESG with FMA or standard ESG alone. The primary outcome is the difference between groups in percentage total body weight loss at 12 months. Secondary outcomes include percent excess weight loss, fasting ghrelin levels, blood pressure and antihypertensive medication use, lipid profile, fasting glucose, insulin, HbA1c, insulin resistance, hepatic steatosis and fibrosis measures, quality of life, pain, gastric symptoms, appetite and eating behavior, and the frequency and severity of adverse events.
详细描述
Obesity is associated with a number of chronic health conditions, including type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease, obstructive sleep apnea, and metabolic liver disease. Treatment options include lifestyle modification, anti-obesity medications, bariatric surgery, and endoscopic weight-loss procedures.
ESG is an endoscopic procedure in which full-thickness sutures are placed to reduce the volume and length of the stomach and create a sleeve-like configuration. The gastric fundus is generally preserved during ESG. Although ESG has been shown to produce clinically meaningful weight loss, weight loss following ESG is generally less than that achieved with surgical sleeve gastrectomy.
One possible explanation for this difference is the role of the gastric fundus in appetite regulation. The fundus contains a large number of cells that produce ghrelin, a hormone involved in hunger and food intake. Procedures that remove or alter the gastric fundus may reduce circulating ghrelin levels. Fundal mucosal ablation (FMA) is an emerging endoscopic technique designed to treat the mucosal lining of the gastric fundus while preserving the stomach itself. Early studies have suggested that FMA may reduce fasting ghrelin levels and may contribute to reductions in hunger and body weight. The ENLIGHT trial is designed to determine whether adding FMA to standard ESG provides additional benefit compared with ESG alone.
Participants assigned to the ESG group will undergo standard ESG under general anesthesia. Participants assigned to the ESG with FMA group will undergo standard ESG together with FMA during the same procedure. Following the procedure, participants in both groups will receive similar standard post-procedure care. Participants will be followed for approximately 52 weeks after the procedure.
Study Significance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥18 years
- •Subjects with a BMI ≥30 kg/m²
- •Subjects have a history of failure of at least one prior weight loss attempt, including but not limited to dietary modification, physical exercise, behavioral modification, pharmacologic therapy (alone or in combination), or other non-surgical weight reduction methods.
- •Willing and able to comply with all study requirements, including but not limited to signing a written informed consent form prior to participation, routine follow-up visit schedule, completing all required laboratory, imaging, and additional assessments, and participating in dietary counseling sessions.
- •Women of childbearing potential (i.e., not postmenopausal and not surgically sterilized) must agree to use adequate and effective contraception methods throughout the study period.
- •Able to travel to visit the study site and have access to the internet to facilitate remote follow-up activities, as applicable.
排除标准
- •Prior gastric or bariatric surgery/procedure that may affect the anatomy or feasibility of the intervention, (e.g; prior Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, endoscopic sleeve gastroplasty).
- •Clinically significant structural abnormality that may increase procedural risk or interfere with endoscopic access
- •Conditions associated with increased bleeding (e.g., severe coagulopathy, severe immunocompromise).
- •Conditions that may affect weight, eating behavior, (e.g; GI motility disorders, gastroparesis, chronic abdominal pain, eating disorders, or active psychological conditions).
- •Pregnancy, breastfeeding, or any other condition that, in the opinion of the investigator or treating physician, would make participation unsafe or interfere with study procedures.
- •Other cases deemed by the examining physician as unsuitable for safe treatment.
研究组 & 干预措施
ESG with Fundal Mucosal Ablation
干预措施: Endoscopic Sleeve Gastroplasty (ESG) (Procedure)
ESG with Fundal Mucosal Ablation
干预措施: Fundal Mucosal Ablation (Procedure)
Endoscopic Sleeve Gastroplasty (ESG) Alone
干预措施: Endoscopic Sleeve Gastroplasty (ESG) (Procedure)
结局指标
主要结局
Percentage Change in Total Body Weight (%TBWL) from baseline to 1 month
时间窗: Baseline to 1 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 3 month
时间窗: Baseline to 3 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 6 month
时间窗: Baseline to 6 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 9 month
时间窗: Baseline to 9 month
Percentage Change in Total Body Weight (%TBWL) from baseline to 12 month
时间窗: Baseline to 12 month
次要结局
- Percent change in Excess Weight Loss (%EWL) from baseline to 1 month(Baseline to 1 month)
- Percent change in Excess Weight Loss (%EWL) from baseline to 3 month(Baseline to 3 month)
- Percent change in Excess Weight Loss (%EWL) from baseline to 6 month(Baseline to 6 month)
- Percent change in Excess Weight Loss (%EWL) from baseline to 9 month(Baseline to 9 month)
- Percent change in Excess Weight Loss (%EWL) from baseline to 12 month(Baseline to 12 month)
- Number of Participants With Procedure-Related Adverse Events (1 Month)(Up to 1 month after procedure)
- Number of Participants With Procedure-Related Adverse Events (3 Month)(Up to 3 month after procedure)
- Number of Participants With Procedure-Related Adverse Events (6 Month)(Up to 6 month after procedure)
- Number of Participants With Procedure-Related Adverse Events (9 Month)(Up to 9 month after procedure)
- Number of Participants With Procedure-Related Adverse Events (12 Month)(Up to 12 month after procedure)
- Change in Serum Ghrelin level from baseline to 1 month(Baseline to 1 month)
- Change in Serum Ghrelin level from baseline to 6 month(Baseline to 6 month)
- Change in Serum Ghrelin level from baseline to 12 month(Baseline to 12 month)
- Change in Systolic Blood Pressure from Baseline to 1 Month(Baseline to 1 month)
- Change in Diastolic Blood Pressure from Baseline to 1 Month(Baseline to 1 month)
- Change in Systolic Blood Pressure from Baseline to 3 Months(Baseline to 3 months)
- Change in Diastolic Blood Pressure from Baseline to 3 Months(Baseline to 3 months)
- Change in Systolic Blood Pressure from Baseline to 6 Months(Baseline to 6 months)
- Change in Diastolic Blood Pressure from Baseline to 6 Months(Baseline to 6 months)
- Change in Systolic Blood Pressure from Baseline to 9 Months(Baseline to 9 months)
- Change in Diastolic Blood Pressure from Baseline to 9 Months(Baseline to 9 months)
- Change in Systolic Blood Pressure from Baseline to 12 Months(Baseline to 12 months)
- Change in Diastolic Blood Pressure from Baseline to 12 Months(Baseline to 12 months)
- Change in Fasting Plasma Glucose from Baseline to 1 Month(Baseline to 1 month)
- Change in Fasting Plasma Glucose from Baseline to 6 Months(Baseline to 6 months)
- Change in Fasting Plasma Glucose from Baseline to 12 Months(Baseline to 12 months)
- Change in Fasting Serum Insulin Concentration from Baseline to 1 Month(Baseline to 1 month)
- Change in Fasting Serum Insulin Concentration from Baseline to 6 Months(Baseline to 6 months)
- Change in Fasting Serum Insulin Concentration from Baseline to 12 Months(Baseline to 12 months)
- Change in Hemoglobin A1c (HbA1c) from Baseline to 1 Month(Baseline to 1 month)
- Change in Hemoglobin A1c (HbA1c) from Baseline to 6 Months(Baseline to 6 months)
- Change in Hemoglobin A1c (HbA1c) from Baseline to 12 Months(Baseline to 12 months)
- Change in Total Cholesterol from Baseline to 1 Month(Baseline to 1 month)
- Change in Total Cholesterol from Baseline to 6 Months(Baseline to 6 months)
- Change in Total Cholesterol from Baseline to 12 Months(Baseline to 12 months)
- Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 1 Month(Baseline to 1 month)
- Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 6 Months(Baseline to 6 months)
- Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 12 Months(Baseline to 12 months)
- Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 1 Month(Baseline to 1 month)
- Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 6 Months(Baseline to 6 months)
- Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 12 Months(Baseline to 12 months)
- Change in Triglycerides from Baseline to 1 Month(Baseline to 1 month)
- Change in Triglycerides from Baseline to 6 Months(Baseline to 6 months)
- Change in Triglycerides from Baseline to 12 Months(Baseline to 12 months)
- Change in Hepatic Steatosis Index (HSI) from Baseline to 1 Month(Baseline to 1 month)
- Change in Hepatic Steatosis Index (HSI) from Baseline to 6 Months(Baseline to 6 months)
- Change in Hepatic Steatosis Index (HSI) from Baseline to 12 Months(Baseline to 12 months)
- Change in Liver Stiffness Measurement from Baseline to 1 Month(Baseline to 1 month)
- Change in Liver Stiffness Measurement from Baseline to 6 Months(Baseline to 6 months)
- Change in Liver Stiffness Measurement from Baseline to 12 Months(Baseline to 12 months)
- Change in Quality of Life Score from Baseline to 1 Month(Baseline to 1 month)
- Change in Quality of Life Score from Baseline to 3 Months(Baseline to 3 months)
- Change in Quality of Life Score from Baseline to 6 Months(Baseline to 6 months)
- Change in Quality of Life Score from Baseline to 12 Months(Baseline to 12 months)
研究者
Shailendra Singh
Professor & Director of Advanced Therapeutic Endoscopy, Director of Bariatric Endoscopy
West Virginia University