search
Back to results

Total Motorized Spiral Enteroscopy Trial (TMSET)

Primary Purpose

Small Bowel Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motorized Spiral Enteroscopy
Sponsored by
Evangelisches Krankenhaus Düsseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Small Bowel Disease focused on measuring endoscopy, motorized spiral enteroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Motorized Spiral Enteroscopy

    Arm Description

    Patients with indication for total enteroscopy. day1: anterograde motorized spiral enteroscopy, day 2: retrograde motorized spiral enteroscopy

    Outcomes

    Primary Outcome Measures

    Rate of total enteroscopy by Motorized Spiral Enteroscopy
    Total enteroscopy by: a complete anterograde approach or a combined anterograde and retrograde approach

    Secondary Outcome Measures

    Procedural Success Rate
    of anterograde and retrograde approach
    Procedural time
    of anterograde and retrograde approach
    Depth of maximum insertion to the small bowel
    anterograde and retrograde
    Diagnostic yield
    anterograde and retrograde
    Therapeutic yield
    anterograde and retrograde
    Adverse events
    anterograde and retrograde, serious adverse events

    Full Information

    First Posted
    February 13, 2018
    Last Updated
    February 13, 2018
    Sponsor
    Evangelisches Krankenhaus Düsseldorf
    Collaborators
    Université Libre de Bruxelles
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03438695
    Brief Title
    Total Motorized Spiral Enteroscopy Trial
    Acronym
    TMSET
    Official Title
    Total Motorized Spiral Enteroscopy Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 21, 2018 (Anticipated)
    Primary Completion Date
    February 21, 2019 (Anticipated)
    Study Completion Date
    February 28, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Evangelisches Krankenhaus Düsseldorf
    Collaborators
    Université Libre de Bruxelles

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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: a complete anterograde approach 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Small Bowel Disease
    Keywords
    endoscopy, motorized spiral enteroscopy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Motorized Spiral Enteroscopy
    Arm Type
    Experimental
    Arm Description
    Patients with indication for total enteroscopy. day1: anterograde motorized spiral enteroscopy, day 2: retrograde motorized spiral enteroscopy
    Intervention Type
    Procedure
    Intervention Name(s)
    Motorized Spiral Enteroscopy
    Intervention Description
    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 Measure Information:
    Title
    Rate of total enteroscopy by Motorized Spiral Enteroscopy
    Description
    Total enteroscopy by: a complete anterograde approach or a combined anterograde and retrograde approach
    Time Frame
    2 days
    Secondary Outcome Measure Information:
    Title
    Procedural Success Rate
    Description
    of anterograde and retrograde approach
    Time Frame
    2 days
    Title
    Procedural time
    Description
    of anterograde and retrograde approach
    Time Frame
    2 days
    Title
    Depth of maximum insertion to the small bowel
    Description
    anterograde and retrograde
    Time Frame
    2 days
    Title
    Diagnostic yield
    Description
    anterograde and retrograde
    Time Frame
    2 days
    Title
    Therapeutic yield
    Description
    anterograde and retrograde
    Time Frame
    2 days
    Title
    Adverse events
    Description
    anterograde and retrograde, serious adverse events
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Torsten Beyna, MD
    Phone
    +49-211-9191605
    Email
    torsten.beyna@evk-duesseldorf.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Horst Neuhaus, MD, PhD
    Phone
    +49-211-9191605
    Email
    horst.neuhaus@evk-duesseldorf.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Torsten Beyna, MD
    Organizational Affiliation
    EVK Düsseldorf, Germany
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    33144239
    Citation
    Beyna T, Arvanitakis M, Schneider M, Gerges C, Hoellerich J, Deviere J, Neuhaus H. Total motorized spiral enteroscopy: first prospective clinical feasibility trial. Gastrointest Endosc. 2021 Jun;93(6):1362-1370. doi: 10.1016/j.gie.2020.10.028. Epub 2020 Nov 2.
    Results Reference
    derived

    Learn more about this trial

    Total Motorized Spiral Enteroscopy Trial

    We'll reach out to this number within 24 hrs