European Novel Motorized Spiral Endoscopy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 3
- 主要终点
- Diagnostic yield of NMSE in patients with suspected small bowel diseases
研究概览
简要总结
The subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. The system is similar to other currently marketed endoscopes in that it incorporates a flexible insertion tube, light source, digital imaging, and channels for passing accessories for sample collection or therapeutic interventions. The NMSE system is unique in that it incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft spiral-shaped "fins", pleats the small bowel on to the endoscope's insertion tube, thereby allowing rapid and atraumatic access deep into the small bowel. The system also includes a display monitor, a motor control unit, device to display measured motor current and signal torque, and a set of foot pedals. Motorization of the Spiral Enteroscope and limitation of rotation to a short cuff instead of a long overtube promise to accelerate the procedure, to facilitate insertion and to improve maneuvering the instrument in comparison to conventional spiral enteroscopy
详细描述
General anesthesia and/or sedation will be prescribed according to institutional practices and clinical judgment; type, amount and duration will be recorded.
A standard esophagogastroduodenoscopy (EGD) will be performed prior to the enteroscopy. If during this preliminary exam the endoscopist identifies any stricture or believes the patient has anatomy that would cause excessive resistance during Novel Motorized Spiral insertion or examination, the patient will be withdrawn from the study and the reason for study withdrawal will be noted.
The Novel Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, (controlled directly by the operating physician via the foot pedal). If at any point a stricture is observed or excessive resistance to the advancement of the endoscope is encountered, further advancement of the endoscope must cease and the reason for procedure termination documented on the case report form.
After reaching the depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal. Maximum depth of insertion will be recorded as the maximum insertion depth when failure to advance the endoscope tip after repositioning the patient, applying abdominal pressure and/or using other standard measures fails to advance the endoscope OR the investigator decides to terminate advancement based on clinical judgment. During withdrawal, the endoscopist will cumulatively estimate the length of bowel released from the endoscope tip in order to calculate the total depth of insertion. Insertion depth will be referenced to the Ligament Treitz. If the clinician decides to mark the point of maximum insertion, the tissue may be tattooed by first creating a saline bleb, followed by the injection of India ink (e.g., SPOT).
Tissue sampling and/or therapies will be performed during withdrawal as clinically appropriate. The details of all sampling and/or therapies (number, type & location) will be recorded.
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
- 是
入选标准
- •Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive videocapsule endoscopy (VCE) or negative VCE in patients who have ongoing bleeding shown by overt bleeding or continued need for blood transfusions
- •Abdominal pain or chronic diarrhoea with positive findings of small bowel imaging examinations
- •Noncontributory ileocolonoscopy and suspicion of Crohn's disease on small-bowel cross-sectional imaging modalities or small-bowel capsule endoscopy
- •Further evaluation of known Crohn's disease or therapeutic indications in Crohn's disease
- •Imaging tests suspicious for small-bowel tumour
- •Large polyps (>10-15mm) discovered by radiological examination or small-bowel capsule endoscopy in patients with Peutz-Jeghers syndrome
- •Nonresponsive or refractory coeliac disease
排除标准
- •Age under 18 years
- •Health status American Society of Anesthesiologists classification (ASA) 4
- •Pregnancy
- •Coagulopathy (INR≥2.0, Platelets < 70/nl)
- •Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
- •Any medical contraindication to standard enteroscopy
- •Presence of any intraluminal or extraluminal foreign body in the abdominal cavity
- •Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable)
- •Known or suspected bowel obstruction or stenosis or history of bowel obstruction
- •Known coagulation disorder
- •Known or suspected esophageal stricture or Schatzki ring
- •Known gastric or esophageal varices
- •Suspected perforation of the GI tract
- •Inability to tolerate sedation or general anesthesia for any reason
- •Inability to tolerate endotracheal intubation
- •Absence of a signed informed consent
研究组 & 干预措施
motorized spiral enteroscopy
Novel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach.
干预措施: motorized spiral enteroscopy (Procedure)
结局指标
主要结局
Diagnostic yield of NMSE in patients with suspected small bowel diseases
时间窗: 30 days
次要结局
- Therapeutic yield(30 days)
- Procedural success(30 days)
- Procedural time (minutes)(30 days)
- Depth of maximal insertion (cm)(30 days)
- Adverse events(30 days)
研究者
Torsten Beyna
MD
Evangelisches Krankenhaus Düsseldorf