NCT05264363已完成不适用
Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Duration of gastric contractility on manometry
研究概览
简要总结
In order to validate that the VIPUN, Gastric Monitoring System (GMS) is a gastric motility monitoring system, we intend to show that the VIPUN GMS can assess motility through pressure measurement similar to high-resolution manometry (HRM).
In addition, the study aims to contribute to the design and development of a position confirmation functionality integrated in the VIPUN Gastric Monitoring System by establishing volume-pressure relations in the stomach and esophagus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Signed Informed Consent Form
- •Aged between and including 18 and 65 years
- •In good health on the basis of medical history and anamnesis by the Principal Investigator (or delegate)
- •Agrees to refrain from drug, non-allowed medication, herbal supplement and dietary supplement intake on the day of the study visit
- •Agrees to an overnight fast in advance of the study visit
排除标准
- •Current or chronic gastrointestinal symptoms
- •Use of any medication that might affect gastric function or visceral sensitivity in the opinion of the PI
- •(Suspected) current use of illicit drugs
- •Psychiatric or neurological illness
- •Any history of gastrointestinal surgery that could influence normal gastric function in the opinion of the PI, including, but not limited to gastrectomy, esophagectomy, duodenotomy, pancreatectomy, bariatric surgery (bypass surgery, gastric banding...), placement of neuromodulator
- •Simultaneous participation in other clinical studies
- •Suspected or confirmed basal skull fracture, mid face trauma or maxillofacial trauma
- •Nasopharyngeal surgery in the last 30 days
- •History of severe coagulation abnormalities
- •Therapeutic or prophylactic anticoagulation
- •Gastrointestinal bleeding
- •Ischemic bowel
- •Peritonitis
- •Deviated nasal septum impeding catheter placement
- •Inability to pass a feeding tube through the nares (e.g. in case of anatomical features, nasal congestion or blockage)
- •Recent (< 30 days) caustic ingestion (due to risk of esophageal rupture)
- •Recent (< 30 days) esophageal varices (active, untreated or recently banded/cauterized)
- •History of esophageal strictures
- •History of gastric varices
- •History of gastric obstruction
- •History of gastrectomy, esophagectomy, duodeno-pancreatectomy, bypass surgery, gastric banding, bariatric balloon, or short bowel syndrome
- •History of gastrostomy
- •Allergy to components of the VIPUN Catheter
- •Pregnancy or breastfeeding
- •Allergy to components of the enteral nutrition
- •Allergy to the available lubricants
- •Allergy to the available local anesthetic
- •Recent infection with SARS-CoV-2 (in the last 2 weeks prior to study visit).
结局指标
主要结局
Duration of gastric contractility on manometry
时间窗: protocol time T=0-120 minutes
Time the smoothed and baseline-corrected gastric manometry pressure exceeds the contraction-threshold
Duration of gastric contractility on VIPUN GMS
时间窗: protocol time T=0-120 minutes
Time the smoothed and baseline-corrected VIPUN GMS pressure exceeds the contraction-threshold.
次要结局
- Manometry contraction frequency(protocol time T=0-120 minutes)
- Nutrient-induced changes in tonic contractility(protocol time T=0-150 minutes)
- VIPUN GMS contraction frequency(protocol time T=0-120 minutes)
- Volume-pressure relation during stepwise inflation(Prior to protocol time T=0 minutes (=start motility recording).)
- Motility Tiled Runner contraction frequency(protocol time T=0-120 minutes)
- Hallmarks of normal motility(protocol time T=0-150 minutes)
- Duration of MMC phases(protocol time T=0-150 minutes)
- Nutrient-induced changes in phasic contractility(protocol time T=0-150 minutes)
研究者
研究点 (2)
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