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Motorized Spiral Colonoscopy Trial: A First Feasibility Trial

NCT03000361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-08-01

No results posted yet for this study

Summary

The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation rate of at least 90 % according to quality guidelines recommendations. All other clinically relevant quality parameters of standard colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study represents the first clinical evaluation of using a motorized spiral assisted endoscope for examination of the colon with potential advantages for patients in terms of effectiveness and convenience of colonoscopy.

Conditions

  • Colonoscopy
  • Safety Issues
  • Adenoma

Interventions

PROCEDURE

Motorized Spiral Colonoscopy

For any pathological finding during colonoscopy standard endoscopic techniques, e.g. forceps biopsy, injection, endoscopic mucosal resection, argon plasma coagulation

Sponsors & Collaborators

  • Olympus

    collaborator INDUSTRY

  • Evangelisches Krankenhaus Düsseldorf

    lead OTHER

Principal Investigators

  • Horst Neuhaus, MD, PhD · Evangelisches Krankenhaus Duesseldorf, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-02-01
Completion
2017-02-01

Countries

  • Germany

Study Locations

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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 NCT03000361 on ClinicalTrials.gov