Total Motorized Spiral Enteroscopy Trial

Small Bowel Disease Clinical Trial

— TMSET  

Official title:

Total Motorized Spiral Enteroscopy Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03438695
• Other study ID #: TMSET 1.0
• Status: Not yet recruiting
• Phase: N/A
• First received: February 13, 2018
• Last updated: February 13, 2018
• Start date: February 21, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2018
• Source: Evangelisches Krankenhaus Düsseldorf
• Contact: Torsten Beyna, MD
• Phone: +49-211-9191605
• Email: torsten.beyna[@]evk-duesseldorf.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 28, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Small Bowel Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Evangelisches Krankenhaus Düsseldorf	Université Libre de Bruxelles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of total enteroscopy by Motorized Spiral Enteroscopy	Total enteroscopy by: a complete anterograde approach; or a combined anterograde and retrograde approach	2 days
Secondary	Procedural Success Rate	of anterograde and retrograde approach	2 days
Secondary	Procedural time	of anterograde and retrograde approach	2 days
Secondary	Depth of maximum insertion to the small bowel	anterograde and retrograde	2 days
Secondary	Diagnostic yield	anterograde and retrograde	2 days
Secondary	Therapeutic yield	anterograde and retrograde	2 days
Secondary	Adverse events	anterograde and retrograde, serious adverse events	3 days