Gastrointestinal Hemorrhage Clinical Trial
— ENMSETOfficial title:
European Novel Motorized Spiral Endoscopy Trial
Verified date | February 2018 |
Source | Evangelisches Krankenhaus Düsseldorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 136 |
Est. completion date | February 6, 2018 |
Est. primary completion date | February 3, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Universite Libre des Bruxelles | Brussels | |
Germany | Evangelisches Krankenhaus | Duesseldorf |
Lead Sponsor | Collaborator |
---|---|
Evangelisches Krankenhaus Düsseldorf | Olympus |
Belgium, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic yield of NMSE in patients with suspected small bowel diseases | 30 days | ||
Secondary | Procedural success | 30 days | ||
Secondary | Procedural time (minutes) | 30 days | ||
Secondary | Depth of maximal insertion (cm) | 30 days | ||
Secondary | Therapeutic yield | 30 days | ||
Secondary | Adverse events | 30 days |
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