Clinical trial · Interventional
European Novel Motorized Spiral Endoscopy Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The subject Novel Motorized Spiral Enteroscope (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. The system is similar to other currently marketed endoscopes in that it incorporates a flexible insertion tube, light source, digital imaging, and channels for passing accessories for sample collection or therapeutic interventions. The NMSE system is unique in that it incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft spiral-shaped "fins", pleats the small bowel on to the endoscope's insertion tube, thereby allowing rapid and atraumatic access deep into the small bowel. The system also includes a display monitor, a motor control unit, device to display measured motor current and signal torque, and a set of foot pedals. Motorization of the Spiral Enteroscope and limitation of rotation to a short cuff instead of a long overtube promise to accelerate the procedure, to facilitate insertion and to improve maneuvering the instrument in comparison to conventional spiral enteroscopy
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Coeliac Disease | — | UNRESOLVED | — |
| Crohn's Disease | — | UNRESOLVED | — |
| Disorder of Small Intestine | — | UNRESOLVED | — |
| Gastrointestinal Hemorrhage | — | UNRESOLVED | — |
| Intestinal Polyposis Syndrome | — | UNRESOLVED | — |
| Iron Deficiency Anaemia | — | UNRESOLVED | — |
| Small Bowel Tumors | Small Intestinal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| motorized spiral enteroscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- motorized spiral enteroscopy
- description
- Novel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach.
- interventionNames
- Procedure: motorized spiral enteroscopy
Primary outcomes (1)
- measure
- Diagnostic yield of NMSE in patients with suspected small bowel diseases
- timeFrame
- 30 days
Secondary outcomes (5)
- measure
- Procedural success
- timeFrame
- 30 days
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive videocapsule 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 * Imaging tests suspicious for small-bowel tumour * Large polyps (\>10-15mm) 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 Anesthesiologists 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 * Inability to tolerate sedation or general anesthesia for any reason * Inability to tolerate endotracheal intubation * Absence of a signed informed consent
References
Publications (1)
- DERIVEDBeyna T, Arvanitakis M, Schneider M, Gerges C, Boing D, Deviere J, Neuhaus H. Motorised spiral enteroscopy: first prospective clinical feasibility study. Gut. 2021 Feb;70(2):261-267. doi: 10.1136/gutjnl-2019-319908. Epub 2020 Apr 24. PMID 32332141