Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 8
- 主要终点
- GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.
A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age or older.
- •History of heartburn or regurgitation for at least 6 months.
- •Esophageal manometry study (conducted within the previous 6 months) demonstrating an adequate resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
- •pH study (conducted within the previous 6 months) demonstrating pathological reflux (defined as the total % time of pH<4.0 > 4.5% or a DeMeester composite score > 14.7).
- •Symptoms requiring daily PPI therapy.
- •GERD-HRQL scores must be > 15 while Off Medication and Off Medication scores must be > 6 points higher than On-Medication scores.
- •Subject is a surgical candidate in the event of a complication related to this procedure, Class ASA I or II.
- •Subject agrees to participate and signs consent form.
排除标准
- •Patient is pregnant.
- •Patient has hiatal hernia > 3 cm.
- •Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (>1 per week) or gas/bloat.
- •Esophagitis grades III or IV by Savary criteria.or type C or D by Los Angeles classification .
- •Barrett's esophagus with dysplasia.
- •Patient has had a previous endoscopic (Endocinch, Stretta, Enteryx, etc.) or surgical repair (Nissen Fundoplication, etc.) performed to treat GERD.
- •Active medical condition that would preclude the subject from finishing this study.
- •Abnormal blood coagulation or the chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis).
- •Pathological changes in soft tissue that would prevent secure fixation of the EPS Implant.
- •Presence of esophageal or gastric varices.
- •Esophageal dysmotility as determined by manometry studies.
- •Esophageal stricture.
结局指标
主要结局
GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment
时间窗: 1, 6, 12, 24, 36, 48 and 60-month post-treatment
次要结局
- Heartburn Score(1, 6, 12, 24, 36, 48 and 60-months post-treatment)
- Regurgitation score(1, 6, 12, 24, 36, 48 and 60-months post-treatment)
- GERD symptom improvement as measured by a visual analog scale(1, 6, 12. 24, 36, 48 and 60-months post-treatment)
- GERD medication use(1, 6, 12, 24, 36, 48 and 60-months post-treatment)
- Esophageal acid exposure(6-months post-treatment)
- Esophageal sphincter (LES) resting pressure as measure by manometry(6-months post-treatment)
- Esophagitis score(6-months post-treatment)