Registry Study of the NDO Surgical Plicator for the Treatment of GERD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 131
- 试验地点
- 13
- 主要终点
- Quality of Life
研究概览
简要总结
The purpose of this study is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicator™. The outcomes will be tracked through analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and medication use questionaires will be administered and documented twice before the procedure and then again at outlined intervals following the procedure. Additionally, financial measures will be evaluated (i.e. pre-procedural and procedural time and costs, staffing/personnel needs during procedure, anesthesia and related costs, recovery time and associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be completed.
This post-market evaluation is a multi-center study design using the NDO Surgical, Inc. Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and medication use before and after treatment with the device. Patient follow-ups will be completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is suitable for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
- •Subject agrees to study participation and signs/dates an informed consent form.
排除标准
- •Significant esophageal dysmotility as determined by manometry
- •Esophagitis grade III or IV (Savary-Miller)
- •Barrett's epithelium
- •Hiatus hernia > 2cm
- •Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
- •Esophageal or gastric varices
- •Previous endoscopic or surgical anti-reflux procedure
- •Other esophageal or gastric surgery
- •Chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis); and
- •Pregnancy.
结局指标
主要结局
Quality of Life
时间窗: 6, 12, 24, 36, 48, 60 months post-treatment
次要结局
- GERD Medication Use(6, 12, 24, 36, 48, 60 months post-treatment)
- Economic outcomes (e.g. procedure time/costs, staffing needs, anesthesia costs, recovery time/costs)(6, 12, 24, 36, 48, 60 months post-procedure)
- Subject satisfaction(6, 12, 24, 36, 48, 60 months post-treatment)