Status:
UNKNOWN
Total Motorized Spiral Enteroscopy Trial
Lead Sponsor:
Evangelisches Krankenhaus Düsseldorf
Collaborating Sponsors:
Université Libre de Bruxelles
Conditions:
Small Bowel Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 w...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03438695
Start Date
February 21 2018
End Date
February 28 2019
Last Update
February 20 2018
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