NCT06655740进行中（未招募）不适用
A Pilot Human Study of the Safety, Tolerability and Effectiveness of the Aqua Medical Circumferential RF Vapor (RFV) Ablation System for Duodenal Mucosal Ablation for the Management of Insulin Requiring Type-2 Diabetes Mellitus
Aqua Medical, Inc.1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Safety Endpoint
研究概览
简要总结
The purpose of this study is to determine whether RFVA of the duodenal mucosa with or without the combination of Semaglutide is a safe and effective treatment to remove the need for insulin therapy among patients with T2D who are on stable doses of insulin.
详细描述
This is a prospective, open-label pilot, to determine safety and efficacy of step-up therapy with RFVA and Semaglutide
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years old but ≤ 65 years old. (Women of childbearing potential must be using one acceptable methods of contraception throughout the study.)
- •Diagnosed with type 2 diabetes mellitus for ≥1 year but ≤ 8 years duration.
- •Glycated haemoglobin ≤ 8.0% (64 mmol/mol).
- •Fasting serum C-peptide ≥ 0.6 ng/mL.
- •Body mass index ≥ 27.5 and ≤ 42.5 kg/m
- •On a daily insulin (basal or combined with short-acting) for at least three months, with a dose ≤ 0.6 U/kg, with a stable dose (≤ 20%) over the last month.
- •Able to comply with study requirements and understand and sign the informed consent form.
排除标准
- •Diagnosis of Type 1 diabetes mellitus
- •Any history of diabetic ketoacidosis or hyperosmolar nonketotic coma
- •Current use of insulin pump.
- •Current, or within the last 3 months, use of a GLP-1 analogue.
- •Current use of a long-acting sulphonylureas (e.g. glibenclamide, chlorpropamide, glimepiride, glyburide)
- •History of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party assistance, in the last year).
- •Known autoimmune disease, including but not limited to celiac disease, duodenal Crohn disease or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other systemic autoimmune connective tissue disorder.
- •Previous gastrointestinal surgery that could limit treatment of the duodenum such as Billroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions. (Prior laparoscopic sleeve gastrectomy (LSG) will not be an exclusion).
- •History of pancreatitis (acute or chronic).
- •Known diabetic gastroparesis.
- •Persistent anaemia, defined as haemoglobin ≤ 9 g/dL
- •Known active hepatitis or active liver disease.
- •Acute gastrointestinal illness in the previous 7 days.
- •Known history of severe irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease.
- •Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including moderate-severe (Grade C or D) esophagitis, dysphagia due to achalasia or stricture/stenosis, esophageal varices, esophageal perforation, or any other disorder of the esophagus.
- •Upper gastrointestinal conditions such as active ulcers, polyps, varices, strictures, congenital or acquired duodenal telangiectasia.
- •Current use of anticoagulation therapy (e.g. warfarin) or direct-acting oral anticoagulants (e.g. rivaroxaban, apixaban, edoxaban and dabigatran) that cannot be discontinued for 3-5 days before and 7 days after the procedure.
- •Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 5 days before and 7 days after the procedure.
- •Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed.
- •Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit.
- •Use of drugs known to affect gastrointestinal motility (e.g. Metoclopramide)
- •Use of weight loss medications such as Sibutramine (e.g. Meridia), Orlistat (e.g. Xenical), Phentermine or over-the-counter weight loss medications (prescription medication)
- •Significant cardiovascular disease, including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within 6 months prior to the Screening Visit.
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type
- •Uncontrolled thyroid disease
- •Mean of 3 separate blood pressure measurements >180 mmHg (systolic) or >100 mmHg (diastolic).
- •Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 (estimated by MDRD).
- •Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.
- •Active illicit substance abuse or alcoholism (>2 drinks/day regularly)
- •Active malignancy within the last 5 years (excluding non-melanoma skin cancers)
- •Active systemic infection
- •Women who are currently breastfeeding.
- •Pregnancy or wish to get pregnant in the next year.
- •Participating in another ongoing clinical trial of an investigational drug or device.
- •Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.
- •Critically ill or has a life expectancy < 3 years.
- •Use of heart pacemaker or other electronic device implants
- •General contraindications to deep or conscious sedation, general anesthesia, high risk as determined by anesthesiologist (e.g., ASA score 4 or higher), or contraindications to upper GI endoscopy.
结局指标
主要结局
Safety Endpoint
时间窗: 1 month
Number of subjects with reported device or procedure related SAEs or UADEs.
Efficacy Endpoint
时间窗: 168 days
Percentage of patients free of insulin at 168 days post RF vapor ablation with an HbA1c ≤ 7.5% (58 mmol/mol)
次要结局
- Proportion of patients who can tolerate semaglutide without need for discontinuation(168 days)
- Reduction in insulin dose from baseline(168 days)
- Proportion of subjects with ≥50% reduction in their insulin dose at 168 days(168 days)
- Percentage of patients who remain off insulin(168 days)
- Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score(168 days)
- Change in BMI(168 days)
- Change in HOMA-IR by visit over time(168 days)
- Change in alanine transaminase(168 days)
- Change in aspartate transaminase(168 days)
- Change in fibrosis index 4 (FIB-4) score(168 days)
- Technical success of duodenal mucosal ablation using RFVA(1 month)
- Procedure time(1 month)
- Proportion of patients who remain free of insulin and Semaglutide(24 weeks)
- Absolute change in HbA1c(84 days)
- Absolute change in HbA1c by visit over time(168 days)
- Change in fasting plasma glucose from baseline(168 days)
- Change in fasting plasma glucose by visit over time(168 days)
- Technical success of duodenal mucosal ablation using RFVA(1 month)
- Procedure time(1 month)
- Proportion of patients who remain free of insulin and Semaglutide(24 weeks)
- Absolute change in HbA1c(84 days)
- Absolute change in HbA1c by visit over time(168 days)
- Change in fasting plasma glucose from baseline(168 days)
- Change in fasting plasma glucose by visit over time(168 days)
- Change in HOMA-IR by visit over time(168 days)
- Change in alanine transaminase(168 days)
- Change in aspartate transaminase(168 days)
- Change in fibrosis index 4 (FIB-4) score(168 days)
- Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score(168 days)
- Change in BMI(168 days)
- Reduction in insulin dose from baseline(168 days)
- Proportion of subjects with ≥50% reduction in their insulin dose at 168 days(168 days)
- Percentage of patients who remain off insulin(168 days)
- Proportion of patients who can tolerate semaglutide without need for discontinuation(168 days)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
RF Vapor Ablation Retreatment of Duodenal Mucosa in Non-responders With Type-2 Diabetes MellitusDiabetes Mellitus, Type 2NCT06724822Aqua Medical, Inc.12
招募中
不适用
Study of Duodenal Mucosal RF Vapor Ablation in Subjects With Type-2 Diabetes MellitusDiabetes Mellitus Type 2NCT05887635Aqua Medical, Inc.40
已完成
不适用
Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)Noninsulin-Dependent Diabetes MellitusDiabetes Mellitus, Type 2NCT02879383Fractyl Health Inc.109
撤回
不适用
Duodenal Exclusion for the Treatment of Type 2 DiabetesDiabetesNCT00534547Medtronic - MITG
已完成
1 期
Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and NaproxenHealthyNCT00366262Wyeth is now a wholly owned subsidiary of Pfizer