Any Symptom Requiring ColonoscopyPhase 4NCT00258531
Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy
A Phase 4 study testing Olympus ScopeGuide®, 3-dimentional magnetic imager in people with Any Symptom Requiring Colonoscopy, run by Sykehuset Telemark at 1 site in Norway.
Trial summary
A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for routine use during colonoscopy. No randomised trials have been performed to evaluate if, and to what extent, the use of this technology may improve the coecal intubation rate and reduce the patient's experience of discomfort and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Symptom Requiring Colonoscopy
- What is being tested?
- Olympus ScopeGuide®, 3-dimentional magnetic imager
- Type of treatment
- Medical device
- How many people
- 360 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2003to Jun 2005
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A successive series of patients referred for routine colonoscopy
Who cannot join
- Age under 18 years
- Pregnant women
- Persons with pacemaker
- Unwillingness to restrict sedation to "on demand"
- Inability to understand the information given
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy for Visualisation of Endoscope Localisation
- A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for routine use during colonoscopy.
- No randomised trials have been performed to evaluate if, and to what extent, the use of this technology may improve the coecal intubation rate and reduce the patient's experience of discomfort and pain by making the insertion of the endoscope easier
Read the detailed description
Endoscopist at different level of experience are to participate. Patients routinely referred to the outpatients department for colonoscopy are asked to participate in a randomised trial where coecal intubation rate and pain experienced by the patient are end-point. Written informed consent is obtained. For each endoscopist, allocated patients are randomised to colonoscopy with no imaging technique (usual care) or using the 3-dimentional imager.
- Conditions
- Any Symptom Requiring Colonoscopy
- Being tested
- Olympus ScopeGuide®, 3-dimentional magnetic imager
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus ScopeGuide®, 3-dimentional magnetic imagerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain experienced during colonoscopy
Secondary outcomes (1)
Coecal intubation rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startJun 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Symptom Requiring ColonoscopyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Investigators
- Geir Hoff, MBChB PhD, Principal investigator, Sykehuset Telemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258531
- Sponsor's protocol ID
- STHF Gastro 01
- Status last verified
- Jun 2005
- First submitted
- 22 Nov 2005
- Last updated
- 28 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3-Dimensional Magnetic Imaging During Colonoscopy for Visualisation of Endoscope Localisation
- ClinicalTrials.gov ID
- NCT00258531
- Acronym / sponsor ID
- STHF Gastro 01
- Conditions
- Any Symptom Requiring Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- Sykehuset TelemarkOther government
- Study start
- Jun 2003
- Study completion
- Jun 2005
- First posted
- 24 Nov 2005 (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.
- A commercial 3-dimentional magnetic imaging system (Olympus ScopeGuide) is available for routine use during colonoscopy.
- No randomised trials have been performed to evaluate if, and to what extent, the use of this technology may improve the coecal intubation rate and reduce the patient's experience of discomfort and pain by making the insertion of the endoscope easier
Detailed description
Endoscopist at different level of experience are to participate. Patients routinely referred to the outpatients department for colonoscopy are asked to participate in a randomised trial where coecal intubation rate and pain experienced by the patient are end-point. Written informed consent is obtained. For each endoscopist, allocated patients are randomised to colonoscopy with no imaging technique (usual care) or using the 3-dimentional imager.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A successive series of patients referred for routine colonoscopy
Key exclusion criteria (5 listed)
- Age under 18 years
- Pregnant women
- Persons with pacemaker
- Unwillingness to restrict sedation to "on demand"
- Inability to understand the information given
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 |
|---|---|---|
| Olympus ScopeGuide®, 3-dimentional magnetic imager | Device | – |
Primary outcome
Pain experienced during colonoscopy
1 secondary outcome
Coecal intubation rate
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 28 Jul 2006.
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.
Geir Hoff, MBChB PhD principal investigator
Sykehuset Telemark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olympus ScopeGuide®, 3-dimentional magnetic imager in people with Any Symptom Requiring Colonoscopy, run by Sykehuset Telemark at 1 site in Norway.
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 1 inclusion and 5 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 28 Jul 2006. 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 Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain experienced during colonoscopy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2006.