NCT02121704

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

April 15, 2014

Last Update Submit

November 5, 2015

Conditions

Failed Conscious Sedation During Procedure

Keywords

SedationColonoscopyPropofolScope guide

Outcome Measures

Primary Outcomes (1)

  • Propofol dose

    At the end of colonoscopy total dose of Propofol applicated will be assessed.

    up to one day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)

Secondary Outcomes (2)

  • Hypoxemia

    up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)

  • Adenoma detection rate

    up to one day

Study Arms (2)

Controll Group

NO 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 NOT BE USED during the investigation.

Intervention

ACTIVE COMPARATOR

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.

Device: Magnetic Endoscope Imaging (Scope Guide)

Interventions

Magnetic Endoscope Imaging (Scope Guide)DEVICE
Also known as: brand name: Scope guide
Intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

München, Deutschland, 81675, Germany

Location

Related Publications (1)

  • Klare P, Hartrampf B, Haller B, Schlag C, Geisler F, Abdelhafez M, Einwachter H, Bajbouj M, Schmid RM, von Delius S. Magnetic endoscope imaging for routine colonoscopy: impact on propofol dosage and patient safety - a randomized trial. Endoscopy. 2016 Oct;48(10):916-22. doi: 10.1055/s-0042-110933. Epub 2016 Jul 21.

    PMID: 27441684DERIVED

Study Officials

  • Peter Klare, MD

    II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany

    PRINCIPAL INVESTIGATOR

  • Stefan von Delius, MD

    Klinikum rechts der Isar der Technischen Universität München

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 23, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

November 6, 2015

Record last verified: 2015-11

Locations

DE(1)