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Total Motorized Spiral Enteroscopy Trial (TMSET)

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: NCT03438695
Recruitment Status : Unknown
Verified February 2018 by Evangelisches Krankenhaus Düsseldorf.
Recruitment status was:  Not yet recruiting
First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Sponsor:
Collaborator:
Université Libre de Bruxelles
Information provided by (Responsible Party):
Evangelisches Krankenhaus Düsseldorf

Brief Summary:

Study design Prospective bicentric non-controlled clinical trial

Study purpose

- to evaluate the efficacy and safety of Novel Motorized Spiral Enteroscopy (NMSE) for total enteroscopy in patients with suspected small bowel diseases with an indication for direct visualization of the entire small bowel

Primary objective

Rate of total enteroscopy by means of NMSE with:

  1. a complete anterograde approach
  2. or a combined anterograde and retrograde approach

Secondary objectives

  • Procedural success of anterograde and retrograde approach
  • Procedural time (minutes)
  • Depth of maximum insertion (cm)
  • Diagnostic yield
  • Therapeutic yield
  • Adverse events

Condition or disease Intervention/treatment Phase
Small Bowel Disease Procedure: Motorized Spiral Enteroscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Total Motorized Spiral Enteroscopy Trial
Estimated Study Start Date : February 21, 2018
Estimated Primary Completion Date : February 21, 2019
Estimated Study Completion Date : February 28, 2019

Arm Intervention/treatment
Experimental: Motorized Spiral Enteroscopy
Patients with indication for total enteroscopy. day1: anterograde motorized spiral enteroscopy, day 2: retrograde motorized spiral enteroscopy
Procedure: Motorized Spiral Enteroscopy
Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, After reaching the cecum or if no further advancement of the endoscope can be achieved 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. If no total enteroscopy was achieved, a submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde peranal enteroscopy is then performed on one of the following days.




Primary Outcome Measures :
  1. Rate of total enteroscopy by Motorized Spiral Enteroscopy [ Time Frame: 2 days ]

    Total enteroscopy by:

    1. a complete anterograde approach
    2. or a combined anterograde and retrograde approach


Secondary Outcome Measures :
  1. Procedural Success Rate [ Time Frame: 2 days ]
    of anterograde and retrograde approach

  2. Procedural time [ Time Frame: 2 days ]
    of anterograde and retrograde approach

  3. Depth of maximum insertion to the small bowel [ Time Frame: 2 days ]
    anterograde and retrograde

  4. Diagnostic yield [ Time Frame: 2 days ]
    anterograde and retrograde

  5. Therapeutic yield [ Time Frame: 2 days ]
    anterograde and retrograde

  6. Adverse events [ Time Frame: 3 days ]
    anterograde and retrograde, serious adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with small bowel disease with an indication for a total enteroscopy, e.g.:
  • Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive Video capsule 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
  • Large polyps (>10-15mm) in the jejunum and ileum 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 Anesthesists 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
  • Known or suspected colonic or ileocecal valve (ICV) stricture
  • 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): NCT03438695


Contacts
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Contact: Torsten Beyna, MD +49-211-9191605 torsten.beyna@evk-duesseldorf.de
Contact: Horst Neuhaus, MD, PhD +49-211-9191605 horst.neuhaus@evk-duesseldorf.de

Sponsors and Collaborators
Evangelisches Krankenhaus Düsseldorf
Université Libre de Bruxelles
Investigators
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Study Chair: Torsten Beyna, MD EVK Düsseldorf, Germany
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Responsible Party: Evangelisches Krankenhaus Düsseldorf
ClinicalTrials.gov Identifier: NCT03438695    
Other Study ID Numbers: TMSET 1.0
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Evangelisches Krankenhaus Düsseldorf:
endoscopy, motorized spiral enteroscopy
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases