Clinical Trial: European Novel Motorized Spiral Endoscopy Trial
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: European Novel Motorized Spiral Endoscopy Trial
Brief Summary: 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
Detailed Summary:
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that would cause excessive resistance during Novel Motorized Spiral insertion or examination, the patient will be withdrawn from the study and the reason for study withdrawal will be noted.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
Sponsor: Evangelisches Krankenhaus Düsseldorf
Current Primary Outcome: Diagnostic yield of NMSE in patients with suspected small bowel diseases [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Procedural success [ Time Frame: 30 days ]
- Procedural time (minutes) [ Time Frame: 30 days ]
- Depth of maximal insertion (cm) [ Time Frame: 30 days ]
- Therapeutic yield [ Time Frame: 30 days ]
- Adverse events [ Time Frame: 30 days ]
Original Secondary Outcome: Same as current
Information By: Evangelisches Krankenhaus Düsseldorf
Dates:
Date Received: November 11, 2016
Date Started: November 2015
Date Completion: July 2017
Last Updated: November 16, 2016
Last Verified: November 2016
