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Total Motorized Spiral Enteroscopy Trial

NCT03438695 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-02-20

No results posted yet for this study

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

Conditions

  • Small Bowel Disease

Interventions

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of the endoscope can be achieved depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal.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

Sponsors & Collaborators

  • Université Libre de Bruxelles

    collaborator OTHER

  • Evangelisches Krankenhaus Düsseldorf

    lead OTHER

Principal Investigators

  • Torsten Beyna, MD · EVK Düsseldorf, Germany

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2019-02-21
Completion
2019-02-28

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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 NCT03438695 on ClinicalTrials.gov