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

About this trial
This is an interventional diagnostic trial for Small Bowel Disease focused on measuring endoscopy, motorized spiral enteroscopy
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
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
NCT ID
NCT03438695
First Posted
February 13, 2018
Last Updated
February 13, 2018
Sponsor
Evangelisches Krankenhaus Düsseldorf
Collaborators
Université Libre de Bruxelles
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
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Total Motorized Spiral Enteroscopy Trial
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