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EndoStim® 下食管括约肌 (LES) 刺激系统治疗反流的研究

2026年7月17日 更新者：EndoStim Inc.

EndoStim® 下食管括约肌 (LES) 刺激系统治疗胃食管反流病 (GERD) 的多中心、随机、双盲、假对照临床研究

本研究的目的是证明下食管括约肌 (LES) 刺激系统在治疗胃食管反流病 (GERD) 中的安全性和有效性。 这项调查是一项多中心、随机、双盲、假对照研究。 植入程序后，受试者将被随机分配到治疗组（立即刺激）或对照组（延迟刺激）六个月，然后是一个额外的开放标签阶段，所有受试者都将接受电刺激。 受试者在刺激后 5 年的延长开放标签随访阶段继续接受刺激治疗。

研究概览

地位

终止

条件

干预/治疗

详细说明

本次调查的目的是证明 EndoStim® 下食管括约肌 (LES) 刺激系统在治疗胃食管反流病 (GERD) 患者中的安全性和有效性。 本研究是一项多中心、随机、双盲、假对照的临床研究。 植入手术后，受试者将被随机分配到治疗组（立即刺激）或对照组（延迟刺激）进行为期 6 个月的双盲阶段，然后是一个额外的开放标签治疗阶段，所有受试者将接受电刺激治疗共12个月。 受试者继续接受刺激治疗，延长的开放标签跟进阶段包括刺激后 18 个月的电话采访，随后是刺激后 5 年的年度访问。

研究类型

介入性

注册 (实际的)

161

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 比利时
      • Leuven、比利时
        • Universitaire Ziekenhuizen Leuven
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85013
        • St. Joseph's Hospital and Medical Center
      • Scottsdale、Arizona、美国、85258
        • HonorHealth Research Institute
    • California
      • Los Angeles、California、美国、90033
        • University of Southern California (USC)
      • Stanford、California、美国、94305
        • Stanford Center for Clinical Research
    • Colorado
      • Englewood、Colorado、美国、80113
        • Institute of Esophageal and Reflux Surgery
    • Florida
      • Tampa、Florida、美国、33606
        • University of South Florida
    • New York
      • New York、New York、美国、10032
        • Columbia University Medical Center
      • New York、New York、美国、10021
        • Cornell University Weill Medical College
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • University of North Carolina
      • Charlotte、North Carolina、美国、28260
        • Carolinas Healthcare System
    • Ohio
      • Cleveland、Ohio、美国、44109
        • The MetroHealth System
      • Columbus、Ohio、美国、43210
        • The Ohio State University Medical Center
    • Oregon
      • Portland、Oregon、美国、97213
        • Oregon Clinic
      • Portland、Oregon、美国、97239
        • Oregon Health Science University
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15224
        • Allegheny Health Network Research Institute
    • Tennessee
      • Nashville、Tennessee、美国、37212
        • Vanderbilt University Medical Center
    • Texas
      • Round Rock、Texas、美国、78665
        • Baylor Scott & White Research Institute
    • Virginia
      • Richmond、Virginia、美国、23298
        • Virginia Commonwealth University
  • 英国
      • London、英国
        • University College London
  • 荷兰
      • Maastricht、荷兰
        • Clinical Trial Center Maastricht

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

22年 至 75年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 能够并愿意提供书面知情同意书
  2. 能够并愿意遵守规定的学习程序和后续计划
  3. 知情同意时 22 - 75 岁
  4. 记录的胃食管反流病 (GERD) 症状超过 6 个月（反流和/或胃灼热，定义为对酸中和或抑制有反应的上腹烧灼痛或胸骨后疼痛），需要每天使用质子泵抑制剂 (PPI) 或其他药物抗反流药物治疗，尽管最大限度的药物治疗或“不耐受”-严重的副作用（例如 对一种 PPI 或轻度/中度副作用（例如 恶心、呕吐、腹泻或腹痛）至至少 2 种不同化学类别的 PPI。
  5. PPI 治疗的症状改善由 PPI 后 GERD 健康相关生活质量 (HRQL) 综合评分≥20 分证明，与非 PPI 综合 GERD-HRQL 评分相比，PPI 改善≥10 分。 满足上述 PPI 不耐受定义的患者不需要有≥10 分的改善。 满足此标准的 on-PPI 分数将是基线访问后恢复 PPI 后完成的 GERD-HRQL 评估的分数。
  6. 在停用 PPI 至少 5 天和停用 H2 受体阻滞剂至少 2 天后进行 pH 监测期间下食管酸暴露过多（定义为远端食管 pH < 4 的时间 > 6.0%）。 至少 18 小时的食管 pH 值记录将被认为是足够的，并且将根据酸暴露百分比时间最高的那一天（至少 18 小时的有效数据）纳入。
  7. 食道炎 ≤ B 级（洛杉矶 (LA) 分类），通过上消化道内窥镜检查，停用 PPI 和 H2 阻滞剂 10-14 天
  8. 对于 > 30% 的吞咽和 > 30% 的 HRM 蠕动收缩或≥ 30% 的蠕动收缩且 DCI >450，食管体收缩幅度 > 30 mmHg。
  9. 能够进行全身麻醉和腹腔镜手术的合适手术候选人

排除标准：

  1. 以前的 EndoStim LES 系统植入物和/或植入物尝试
  2. 既往涉及胃食管交界处或铅植入部位的手术，例如尼森胃底折叠术
  3. 先前用于治疗 GERD 和/或 Barrett 食管的内窥镜干预
  4. 通过内窥镜检查确定大于 3 cm 的食管裂孔疝
  5. 胃轻瘫史
  6. 研究者认为排除抗反流手术的任何非 GERD 食管动力障碍
  7. 食管狭窄病史或已知食管狭窄或显着食管解剖异常（阻塞性病变等）
  8. 巴雷特食管或任何级别的异型增生
  9. C 级或 D 级食管炎病史（LA 分类）
  10. 疑似或确诊食管癌或胃癌病史
  11. 食道或胃底静脉曲张
  12. 在过去 3 个月内每周出现一次以上的吞咽困难症状
  13. 无法忍受 H2 受体阻滞剂或 PPI 药物的停药
  14. 怀疑或已知对钛、铂、铱、不锈钢、硅胶、环氧树脂或尼龙过敏
  15. 体重指数 (BMI) > 35 公斤/平方米
  16. 任何重大的多系统疾病
  17. 自身免疫性疾病或结缔组织疾病（硬皮病、皮肌炎、钙质沉积-雷诺氏-食管硬化指综合征 (CREST)、干燥综合征、夏普综合征等）需要在过去 2 年内进行治疗
  18. 1 型糖尿病或不受控制的 2 型糖尿病 (T2DM) 定义为 HbA1c > 9.5 在过去 6 个月内或在筛查/基线时
  19. 显着心律失常或异位或显着心血管疾病（即 不稳定型心绞痛、血流动力学显着的瓣膜病、严重的充血性心力衰竭）或最近 6 个月内的任何心脏治疗干预。
  20. 最近 6 个月内发生过重大脑血管事件
  21. 现有的植入式电刺激器（起搏器、植入式心律转复除颤器、深部脑刺激器（DBS）、骨生长或盆底刺激器、药泵等）
  22. 有生育能力的女性受试者正在怀孕或哺乳，或打算在试验期间怀孕，但未使用可靠的避孕措施
  23. 目前正在参加其他可能混杂的研究
  24. 研究者确定的活动性感染
  25. 过去 2 年内除基底细胞癌外的任何恶性肿瘤病史
  26. 预期寿命不到3年aa。 诊断为严重精神疾病（双相情感障碍、精神分裂症等）bb。 由研究者或发起人自行决定的任何会干扰对研究终点的准确解释或妨碍参与试验的情况

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
假比较器：Control Group (delayed stimulation)
This group will undergo laparoscopic implantation surgery with or without crural repair (surgeon discretion). The device will not be activated: Sham EndoStim stimulation for first six months of study. It will be activated at the Month 6 visit and provide lower esophageal stimulation from Month 6 thru end of study.
设备：从第 6 个月到研究结束的 EndoStim 刺激
下食道刺激
其他名称：
  • EndoStim 植入式脉冲发生器 (IPG)
  • 下食管刺激
设备：研究前六个月的假 EndoStim 刺激
EndoStim 设备保持“关闭”状态（未提供刺激）
程序：Laparoscopic implantation surgery with or without crural repair
Laparoscopic surgery with or without crural repair to implant the pulse generator and bipolar lead.
实验性的：Treatment Group (immediate stimulation)
The group will undergo laparoscopic implantation surgery with or without crural repair (surgeon discretion). The device will be activated two weeks post-implantation and the subject will receive EndoStim stimulation for first six months of study and continue with EndoStim stimulation from Month 6 thru end of study.
设备：从第 6 个月到研究结束的 EndoStim 刺激
下食道刺激
其他名称：
  • EndoStim 植入式脉冲发生器 (IPG)
  • 下食管刺激
设备：前六个月研究的 EndoStim 刺激
下食道刺激
其他名称：
  • EndoStim 植入式脉冲发生器 (IPG)
  • 下食管刺激
程序：Laparoscopic implantation surgery with or without crural repair
Laparoscopic surgery with or without crural repair to implant the pulse generator and bipolar lead.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Primary Safety Endpoint: Rate of Device and/or Procedure-related Serious Adverse Events After 12 Months Post-implant
大体时间：12 months after implant
Rate of occurrence of device and/or procedure-related serious adverse events after 12 months of implant
12 months after implant
Primary Efficacy Endpoint: Percentage of Subjects Achieving pH Success (pH<4 for More Than 5.3% of Time or at Least 50% Improvement in pH Compared to Baseline)
大体时间：Comparison of 6 months to baseline data
Comparison between treatment and control group: percentage of subjects achieving pH success ((pH<4 for more than 5.3% of time or at least 50% improvement in pH compared to baseline)
Comparison of 6 months to baseline data

次要结果测量

结果测量
措施说明
大体时间
Secondary Endpoint (Open-label, 12 Months on Stimulation): GERD-HRQL Score (Off-PPI/H2 Blocker)
大体时间：12 months on stimulation
The secondary efficacy endpoint was the number of subjects achieving GERD symptom success defined as an improvement in the composite GERD Health-related Quality of Life (GERD-HRQL) patient reported outcome questionnaire score of 50% or more after 12 months on stimulation compared to the baseline off-PPI or H2 blocker composite GERD-HRQL score. Questions regarding heartburn severity and difficulty swallowing are asked on scale of 0 to 5: 0 = No symptoms; 1 = Symptoms noticeable but not bothersome; 2 = Symptoms noticeable and bothersome but not every day; 3 = Symptoms bothersome every day; 4 = Symptoms affect daily activities; and 5 = Symptoms are incapacitating - unable to do activities. The composite score is calculated by adding the responses to the individual questions. The minimum score possible is 0 and the maximum score is 45.
12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): GERD-HRQL On-PPI
大体时间：12 months on stimulation
Composite GERD Health-related Quality of Life (GERD-HRQL) patient reported outcome questionnaire scores. Questions regarding are asked on scale of 0 to 5: 0 = No symptoms; 1 = Symptoms noticeable but not bothersome; 2 = Symptoms noticeable and bothersome but not every day; 3 = Symptoms bothersome every day; 4 = Symptoms affect daily activities; and 5 = Symptoms are incapacitating - unable to do activities. The composite score is calculated by adding the responses to the individual questions. The minimum score possible is 0 and the maximum score is 45. Previous versions of the protocol and case report forms did not include the question about bloating; thus, this question was not included in the calculation of the composite score. The lower scores are associated with less impactful symptoms.
12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Mean Percentage (%) of Time Distal Supine Esophageal pH is <4.0
大体时间：12 months on stimulation
Patients with a minimum of 18 hours of Bravo Esophageal pH monitoring had the percent time calculated for time where the distal supine esophageal pH < 4.0 over the total number of hours recorded. Data are reported as change from baseline.
12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Severity of Heartburn Symptoms
大体时间：12 months on stimulation

Heartburn symptoms were recorded by the patient in a diary. Severity was scored on a scale of 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe). Low scores represent a better outcome.

Median daily severity of worst episode during the on-PPI/H2 blocker period reported as change from baseline.
12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Regurgitation Symptom Severity
大体时间：12 months on stimulation

Regurgitation symptoms were recorded by the patient in a diary. Severity was scored on a scale of 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe). Low scores represent a better outcome.

Median daily severity of worst episode reported as change from baseline.
12 months on stimulation
Secondary Endpoint (Open-label,12 Months on Stimulation): Stop Regular Use of Acid-suppression Medication
大体时间：12 months on stimulation
Number of subjects reporting more than 50% of days with no PPI medication use in the patient diary during the "on-PPI" period.
12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): 50% or More Reduction in Nocturnal Symptoms of Heartburn
大体时间：12 months on stimulation

Heartburn symptoms were recorded by the patient in a diary. Severity was scored on a scale of 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe).

Percent of reported time with any heartburn symptoms at night during the on-PPI period.
12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): 50% or More Reduction in Nocturnal Symptoms of Regurgitation
大体时间：12 months on stimulation

Regurgitation symptoms were recorded by the patient in a diary. Severity was scored on a scale of 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe).

Percent of reported time with any regurgitation symptoms at night during the on-PPI period. Data are reported as change from baseline.
12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Quality of Life (SF-12) - Physical Health
大体时间：12 months on stimulation

The Short Form Health Survey (SF-12) is used to assess quality of life. Scores are generated from the Quality Metric proprietary algorithm. The mean score in the US general population is set to 50 with standard deviation of 10. The higher scores indicate a higher quality of life.

Number of patients with any improvement
12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Quality of Life (SF-12) - Mental Health
大体时间：12 months on stimulation

The Short Form Health Survey (SF-12) was used to assess quality of life. Scores are generated from the Quality Metric proprietary algorithm. The mean score in the US general population is set to 50 with standard deviation of 10. The higher scores indicate a higher quality of life.

Number of patients with any improvement
12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Stop All Use of Acid-suppression Medication
大体时间：12 months on stimulation
Number of subjects reporting zero days of PPI medication use in the patient diary during the "on-PPI" period.
12 months on stimulation
Secondary Endpoint (Blinded): Regurgitation Symptom Frequency
大体时间：6-month follow-up visit
As recorded in the patient diary (includes both day and night) for the on-PPI period. Data are reported as change from baseline of the percent of reported time with any regurgitation symptoms.
6-month follow-up visit
Secondary Endpoint (Blinded): Bravo Esophageal pH Monitoring Fraction Time
大体时间：6-month visit
Fraction of time (percent of total) with distal esophageal pH < 4.0 using Bravo Esophageal pH Monitoring from baseline to the Month 6 Visit for patients who were off PPI medication for a minimum of five days before the test. Data are reported as change from baseline.
6-month visit
Secondary Endpoint (Blinded): Acid Suppression Medication Use
大体时间：6-month follow-up visit
Percent of time reported in the patient diary with any PPI medication use for symptoms. Data are reported as change from baseline.
6-month follow-up visit
Secondary Endpoint (Blinded): Heartburn Symptom Frequency
大体时间：6-month follow-up visit
Heartburn symptom frequency (day and night) as measured by Subject Diary during the on-PPI period. Data are reported as change from baseline of the percent of reported time with any heartburn symptoms.
6-month follow-up visit
Secondary Endpoint (Blinded): Quality of Life (SF-12) - Mental Health
大体时间：6-month follow-up visit
The Short Form Health Survey (SF-12) was used to assess quality of life, both in terms of physical health and mental health. Scores are generated from the Quality Metric's proprietary algorithm. The mean score in the US general population is set to 50 with standard deviation of 10. The higher scores indicate a higher quality of life. Data are reported as change from baseline.
6-month follow-up visit
Secondary Endpoint (Blinded): Quality of Life (SF-12) - Physical Heath Score
大体时间：6-month follow-up visit
The Short Form Health Survey (SF-12) was used to assess quality of life, both in terms of physical health and mental health. Scores are generated from the Quality Metric's proprietary algorithm. The mean score in the US general population is set to 50 with standard deviation of 10. Higher scores indicate a higher quality of life. Data are reported as change from baseline.
6-month follow-up visit

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

EndoStim Inc.

调查人员

  • 首席研究员：Nicholas J Shaheen, MD, MPH、University of North Carolina
  • 首席研究员：Vic Velanovich, MD、University of South Florida

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年5月1日

初级完成 (实际的)

2019年10月1日

研究完成 (实际的)

2019年10月1日

研究注册日期

首次提交

2016年4月15日

首先提交符合 QC 标准的

2016年4月20日

首次发布 (估计的)

2016年4月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CS-100

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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