MedTrace Logo

European Novel Motorized Spiral Endoscopy Trial

NCT02965209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2018-02-14

No results posted yet for this study

Summary

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

  • Disorder of Small Intestine
  • Gastrointestinal Hemorrhage
  • Iron Deficiency Anaemia
  • Crohn's Disease
  • Small Bowel Tumors
  • Intestinal Polyposis Syndrome
  • Coeliac Disease

Interventions

PROCEDURE

motorized spiral enteroscopy

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. When the region of interest in the small bowel is reached by NMSE standard endoscopic techniques, e.g. argon plasma coagulation (APC), forceps biopsy or endoscopic mucosal resection (EMR) are performed for treatment and/or tissue acquisition.

Sponsors & Collaborators

  • Olympus

    collaborator INDUSTRY

  • Evangelisches Krankenhaus Düsseldorf

    lead OTHER

Principal Investigators

  • Horst Neuhaus, MD · Evangelisches Krankenhaus Duesseldorf

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-02-03
Completion
2018-02-06

Countries

  • Belgium
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02965209 on ClinicalTrials.gov