European Novel Motorized Spiral Endoscopy Trial (ENMSET)
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|ClinicalTrials.gov Identifier: NCT02965209|
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Disorder of Small Intestine Gastrointestinal Hemorrhage Iron Deficiency Anaemia Crohn`s Disease Small Bowel Tumors Intestinal Polyposis Syndrome Coeliac Disease||Procedure: motorized spiral enteroscopy||Not Applicable|
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that would cause excessive resistance during Novel Motorized Spiral insertion or examination, the patient will be withdrawn from the study and the reason for study withdrawal will be noted.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After reaching the depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal.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.
The comfort and cardiopulmonary stability of the patient will be monitored throughout the procedure, as per the standard of care - this includes continuous pulse oximetry, blood pressure, and heart rate monitoring.
Photographs or video recordings are used to document any significant lesions and any tissue trauma.
Postprocedural measures Patients will be hospitalized for at least 24 hours after NMSE because of the potential risk of delayed adverse events. Only liquid diet is allowed during the first 12 hours in asymptomatic patients. Clinical investigation and determination of the blood cell count and the serum level of C-reactive protein will be done after 24 hours. 30 days after the procedure patients will be interviewed by a telephone call for evaluation of complaints or delayed complications. Discomfort (location and severity (0-10 VAS) should be documented immediately after NMSE, after 24 hours and before discharge.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||European Novel Motorized Spiral Endoscopy Trial|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||February 3, 2018|
|Actual Study Completion Date :||February 6, 2018|
Experimental: 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.
Procedure: 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. When the region of interest in the small bowel is reached by NMSE standard endoscopic techniques, e.g. argon plasma coagulation (APC), forceps biopsy or endoscopic mucosal resection (EMR) are performed for treatment and/or tissue acquisition.
Other Name: standard endoscopic interventions (not experimental)
- Diagnostic yield of NMSE in patients with suspected small bowel diseases [ Time Frame: 30 days ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965209
|Universite Libre des Bruxelles|
|Duesseldorf, Germany, 40217|
|Principal Investigator:||Horst Neuhaus, MD||Evangelisches Krankenhaus Duesseldorf|