Failed Conscious Sedation During ProcedureMEXICONCT02121704
Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage
A study testing Magnetic Endoscope Imaging (Scope Guide) in people with Failed Conscious Sedation During Procedure, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Failed Conscious Sedation During Procedure
- What is being tested?
- Magnetic Endoscope Imaging (Scope Guide)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical indication for colonoscopy
- age >18 years
- written consent given by patient
- investigation under sedation with propofol
Who cannot join
- 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)
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- allergy to propofol
- pre-existing hypotension, bradycardia or hypoxemia
- history of sedation accidents
Trial locations and contacts
1 site in 1 country.
Germany1 site
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
München, Deutschland, 81675
About this study
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.
- Being tested
- Magnetic Endoscope Imaging (Scope Guide)
- Keywords
- Sedation, Colonoscopy, Propofol, Scope guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Endoscope Imaging (Scope Guide)Device
Also called brand name: Scope guide
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Magnetic Endoscope Imaging (Scope Guide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol dose
At the end of colonoscopy total dose of Propofol applicated will be assessed.
Measured: 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
Oxygen saturation will be measured for the duration of colonoscopy/hospital stay.
Measured: 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
Measured: up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Conscious Sedation During ProcedureStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Sponsor
- Investigators
- Peter Klare, MD, Principal investigator, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, GermanyStefan von Delius, MD, Study director, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121704
- Sponsor's protocol ID
- MEXICO
- Acronym
- MEXICO
- Status last verified
- Nov 2015
- First submitted
- 15 Apr 2014
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27441684
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage
- ClinicalTrials.gov ID
- NCT02121704
- Acronym / sponsor ID
- MEXICO / MEXICO
- Keywords
- Sedation, Colonoscopy, Propofol, Scope guide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Magnetic Endoscope Imaging (Scope Guide)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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- medical indication for colonoscopy
- age >18 years
- written consent given by patient
- investigation under sedation with propofol
Key exclusion criteria (9 listed)
- application of any other sedative than propofol
- age < 18 years
- pregnant women
- patients denying written consent
- ASA class IV, V and VI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Endoscope Imaging (Scope Guide)Also: brand name: Scope guide | Device | Intervention |
Primary outcome
Propofol dose
Time frame: up to one day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)
At the end of colonoscopy total dose of Propofol applicated will be assessed.
2 secondary outcomes
Hypoxemia
Time frame: 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
Time frame: up to one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Derived from this study: PubMed 27441684Klare 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Klare, MD principal investigator
II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
Stefan von Delius, MD study director
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Endoscope Imaging (Scope Guide) in people with Failed Conscious Sedation During Procedure, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol dose (time frame: up to one day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.