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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
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
Torsten Beyna, Evangelisches Krankenhaus Düsseldorf

Tracking Information
First Submitted Date  ICMJE November 11, 2016
First Posted Date  ICMJE November 16, 2016
Last Update Posted Date February 14, 2018
Study Start Date  ICMJE November 2015
Actual Primary Completion Date February 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2016)
Diagnostic yield of NMSE in patients with suspected small bowel diseases [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE European Novel Motorized Spiral Endoscopy Trial
Official Title  ICMJE 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 Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Disorder of Small Intestine
  • Gastrointestinal Hemorrhage
  • Iron Deficiency Anaemia
  • Crohn's Disease
  • Small Bowel Tumors
  • Intestinal Polyposis Syndrome
  • Coeliac Disease
Intervention  ICMJE 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)
Study Arms  ICMJE 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.
Intervention: Procedure: motorized spiral enteroscopy
Publications * Beyna T, Arvanitakis M, Schneider M, Gerges C, Böing D, Devière J, Neuhaus H. Motorised spiral enteroscopy: first prospective clinical feasibility study. Gut. 2021 Feb;70(2):261-267. doi: 10.1136/gutjnl-2019-319908. Epub 2020 Apr 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2018)
136
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2016)
132
Actual Study Completion Date  ICMJE February 6, 2018
Actual Primary Completion Date February 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02965209
Other Study ID Numbers  ICMJE ENMSET
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Torsten Beyna, Evangelisches Krankenhaus Düsseldorf
Study Sponsor  ICMJE Evangelisches Krankenhaus Düsseldorf
Collaborators  ICMJE Olympus
Investigators  ICMJE
Principal Investigator: Horst Neuhaus, MD Evangelisches Krankenhaus Duesseldorf
PRS Account Evangelisches Krankenhaus Düsseldorf
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP