Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Magnetic Endoscope Imaging (MEI) is an optional tool which can be switched on at the beginning of colonoscopy. MEI works by creating an electromagnetic field of very low intensity. By that the position of the endoscope can be displayed virtually on a monitor. The use of MEI has been shown to reduce the formation of loops and to ease the removal of existing loops during the investigation. Furthermore, as loops favour the occurrence of pain when the scope is moved forward, patients who underwent colonoscopy with MEI reported less pain at the end of the procedure.

Sedation is used widely during colonoscopy for it has improved the tolerability of the investigation. Most of the patients demand for sedation. In Germany Propofol is recommended as the first-line sedative when endoscopy it is performed in an outpatient setting. The use of Propofol involves the danger of respiratory complications. One reason for the application of Propofol doses is the occurrence of pain during the investigation. We hypothesized that if MEI is used and if loops can be avoided sufficiently lower Propofol doses would be needed. We therefore planned this prospective controlled trial.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Use of Magnetic Endoscopic Imaging for Improving Quality Indicators in Outpatient Colonoscopy

NCT01480830

Colonoscopy

COMPLETED NA

The Effect of ScopeGuide on the Mental Workload of Endoscopist

NCT02092493

Any Symptoms Requiring Colonoscopy

WITHDRAWN NA

Improving Quality of Colonoscopy Using a 3D-imager

NCT00519129

Pain During Colonoscopy

COMPLETED PHASE3

Use of Magnetic Imaging to Asses the Efficacy of Cap Assisted Colonoscopy in Reducing Looping and Improving Patient Acceptance for the Colonoscopy Procedure

NCT00365534

Colonoscopy

WITHDRAWN NA

ColoAssist vs. MEI

NCT01895504

Colorectal Cancer Screening

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Failed Conscious Sedation During Procedure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Controll Group

Patients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. The Magnetic Endoscope Imaging (Scope Guide) function WILL NOT BE USED during the investigation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Patients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. The Magnetic Endoscope Imaging (Scope Guide) function WILL BE USED during the investigation.

Group Type ACTIVE_COMPARATOR

Magnetic Endoscope Imaging (Scope Guide)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnetic Endoscope Imaging (Scope Guide)

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

brand name: Scope guide

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* medical indication for colonoscopy
* age \>18 years
* written consent given by patient
* investigation under sedation with propofol

Exclusion Criteria

* application of any other sedative than propofol
* age \< 18 years
* pregnant women
* patients denying written consent
* ASA class IV, V and VI
* indication for colonoscopy: emergency (e.g. severe rectal bleeding)
* allergy to propofol
* pre-existing hypotension, bradycardia or hypoxemia
* history of sedation accidents

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No