DRKS00014809尚未招募不适用
Re-Do procedure with EndoStim implantation in patients with persistent gastro-oesophageal reflux or dysphagia after fundoplication - Redo-Endostim
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •I. Subject is 18 – 65 years of age at the time of informed consent
- •II. Subject must be able and willing to provide written informed consent
- •III. Subject has undergone a fundoplication in the past (Nissen or Toupet). Between
- •fundoplication and inclusion into this study at least 6 months have to have passed.
- •IV. No more than 6 months before Re-Do procedure: indication for a re-do intervention was determined during an interdisciplinary consultation with objective proof of symptoms and comprehensive gastro-enterological diagnostic.
- •V. No more than 6 months before Re-Do procedure: impedance pH measurement showed a low esophageal acid exposure (pH < 4 in the distal
- •esophagus in = 5,0% of the measurements), at minimum 14 days after
- •discontinuing PPI and 2 days of discontinuing H2 blocker.
- •VI. No more than 6 months before Re-Do procedure: A high resolution manometry (HRM) or a classic manometry of the esophagus was performed
- •VII. No more than 6 months before Re-Do procedure: Objective findings of dysphagia caused by reflux.
- •VIII. If the leading symptom was dysphagia, at least one balloon dilatation intervention was
- •attempted to resolve the problem.
- •IX. Subject is a suitable surgical candidate able to undergo laparoscopic
- •surgery and implantation of the EndoStim LES stimulation system
排除标准
- •I. Subject had a previous EndoStim LES System implant and/or implant attempt
- •II. Female subject of child-bearing potential and is pregnant or nursing, or intends to become
- •pregnant during the trial period, and/or is not using a reliable form of birth control
- •III. Subject is currently enrolled in another research study
- •IV. Subject underwent previous endoscopic intervention for the treatment of GERD and/or a
- •Barrett’s esophagus.
- •V. Other diseases of the upper gastrointestinal tract
- •VI. Subject has suspected or known allergies to titanium, platinum, iridium, stainless steel,
- •silicone, epoxy, or nylon
- •VII. Subject has an active infection confirmed by the investigator
- •VIII. The subject is diagnosed with an upside-down stomach (Gastric volvulus)
- •IX. Subject has a known history of gastroparesis
- •X. The subject is diagnosed with a large hiatal hernia that would need a mesh augmentation.
- •XI. Subject has any non-GERD esophageal motility disorders that in the opinion of investigator
- •preclude an anti-reflux procedure
- •XII. Subject has history of or known esophageal stricture or significant esophageal anatomic
- •abnormalities (obstructive lesions, etc.)
- •XIII. Subject has Barrett’s epithelium with any grade of dysplasia.
- •XIV. Subject has a history of suspected or confirmed esophageal or gastric cancer
- •XV. Subject has esophageal or gastric varices (grade II or larger)
- •XVI. Subject has an autoimmune or a connective tissue disorder (scleroderma, dermatomyositis,
- •Calcinosis-Raynaud’s-Esophagus Sclerodactyly Syndrome (CREST), Sjogren’s Syndrome,
- •Sharp’s Syndrome, etc.) requiring therapy in the preceding 2 years
- •XVII. Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease (i.e.
- •unstable angina pectoris, hemodynamically significant valvular disease, severe congestive
- •heart failure), or any cardiac therapeutic intervention within the last 6 months.
- •XVIII. Subject has had a significant cerebrovascular event within the last 6 months
- •XIX. Subject has an existing implanted electrical stimulator (pacemaker, implantable cardioverter
- •defibrillator, DBS, bone growth or pelvic floor stimulators, drug pumps, etc.)
- •XX. Subject has a history of any malignancy with a life expectancy < 1 year
- •XXI. Subject has a diagnosed major untreated psychiatric disorder (bipolar, schizophrenia, etc.)
- •XXII. Subject has any condition that, at the discretion of the investigator, would interfere with
- •accurate interpretation of the study endpoints or preclude participation in the trial
- •XXIII. Subject is imprisoned
- •XXIV. Subject with alcohol or drug abuse
研究者
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