TMSET: Total Motorized Spiral Enteroscopy Trial

Sponsor

Evangelisches Krankenhaus Düsseldorf (Other)

Overall Status

Unknown status

CT.gov ID

NCT03438695

Collaborator

Université Libre de Bruxelles (Other)

Enrollment

Arm

12.2

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Small Bowel Disease	Procedure: Motorized Spiral Enteroscopy	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Feb 21, 2018

Anticipated Primary Completion Date :

Feb 21, 2019

Anticipated Study Completion Date :

Feb 28, 2019

Arms and Interventions

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of the endoscope can be achieved depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal.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.

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.

Outcome Measures

Primary Outcome Measures

Rate of total enteroscopy by Motorized Spiral Enteroscopy [2 days]
Total enteroscopy by: a complete anterograde approach or a combined anterograde and retrograde approach

Secondary Outcome Measures

Procedural Success Rate [2 days]
of anterograde and retrograde approach
Procedural time [2 days]
of anterograde and retrograde approach
Depth of maximum insertion to the small bowel [2 days]
anterograde and retrograde
Diagnostic yield [2 days]
anterograde and retrograde
Therapeutic yield [2 days]
anterograde and retrograde
Adverse events [3 days]
anterograde and retrograde, serious adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Evangelisches Krankenhaus Düsseldorf
Université Libre de Bruxelles

Investigators

Study Chair: Torsten Beyna, MD, EVK Düsseldorf, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Evangelisches Krankenhaus Düsseldorf

ClinicalTrials.gov Identifier:

NCT03438695

Other Study ID Numbers:

TMSET 1.0

First Posted:

Feb 20, 2018

Last Update Posted:

Feb 20, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Evangelisches Krankenhaus Düsseldorf

endoscopy, motorized spiral enteroscopy

Additional relevant MeSH terms:

Intestinal Diseases

Study Results

No Results Posted as of Feb 20, 2018