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European Novel Motorized Spiral Endoscopy Trial (ENMSET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Diagnostic yield of NMSE in patients with suspected small bowel diseases [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Procedural success [ Time Frame: 30 days ]
  2. Procedural time (minutes) [ Time Frame: 30 days ]
  3. Depth of maximal insertion (cm) [ Time Frame: 30 days ]
  4. Therapeutic yield [ Time Frame: 30 days ]
  5. Adverse events [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Belgium
Universite Libre des Bruxelles
Brussels, Belgium
Germany
Evangelisches Krankenhaus
Duesseldorf, Germany, 40217
Sponsors and Collaborators
Evangelisches Krankenhaus Düsseldorf
Olympus
Investigators
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Principal Investigator: Horst Neuhaus, MD Evangelisches Krankenhaus Duesseldorf
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Responsible Party: Torsten Beyna, MD, Evangelisches Krankenhaus Düsseldorf
ClinicalTrials.gov Identifier: NCT02965209    
Other Study ID Numbers: ENMSET
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Torsten Beyna, Evangelisches Krankenhaus Düsseldorf:
endoscopy
small bowel endoscopy
motorized spiral endoscopy
spiral endoscopy
Additional relevant MeSH terms:
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Crohn Disease
Celiac Disease
Gastrointestinal Hemorrhage
Intestinal Polyposis
Anemia, Iron-Deficiency
Hemorrhage
Pathologic Processes
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Malabsorption Syndromes