Pain During ColonoscopyPhase 3NCT00519129
Improving Quality of Colonoscopy Using a 3D-imager
A Phase 3 study testing 3D-imager in people with Pain During Colonoscopy, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain During Colonoscopy
- What is being tested?
- 3D-imager
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2007to Aug 2010
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients referred for coloscopy on an out-patient basis
Who cannot join
- Pregnancy
- Pacemaker
- Lack of ability to understand information given
- Prior resection of the colon/rectum
- Demanding analgetics prior to start of procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial
Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. We want to investigate whether the 3D-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy
Read the detailed description
Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.
- Conditions
- Pain During Colonoscopy
- Being tested
- 3D-imager
- Keywords
- Pain, Patient satisfaction
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-imagerDevice
Also called Skopguide
3D-imager vs fluoroscopy during coloscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during coloscopy
Measured: instant
Time used to reach the coecum
Measured: instant
Secondary outcomes (6)
coecum-intubation rate
Measured: instant
level achieved when the coecum can not be reached
Measured: instant
Need for assistance by a colleague
Measured: instant
Need for analgetics
Measured: instant
Pain during the first 24 hours after coloscopy
Measured: 24 hours
Polyp detection rate
Measured: instant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2010
- Study completionAug 2010
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 Pain During 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Investigators
- Geir S Hoff, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519129
- Sponsor's protocol ID
- SSHF-Colon-1
- Status last verified
- Aug 2011
- First submitted
- 21 Aug 2007
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holme O, Hoie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8.
PubMed 21481862
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Endoscopic Imaging Versus Standard Colonoscopy in a Routine Colonoscopy Setting: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00519129
- Acronym / sponsor ID
- SSHF-Colon-1
- Conditions
- Pain During Colonoscopy
- Keywords
- Pain, Patient satisfaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Aug 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Aug 2007 (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.
Coloscopy may be a painful procedure for the patient. This is due to a loop-formation of the coloscope. A 3D-real time imager produced by Olympus creates a real-time image of the scope while a traditional fluoroscopy device will only show instant pictures. We want to investigate whether the 3D-imager causes the patient less pain and is more time consuming than ordinary fluoroscopy
Detailed description
Results published in Holme et.al. Gastrointestinal Endoscopy 2011;73:1215-1222.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients referred for coloscopy on an out-patient basis
Key exclusion criteria (5 listed)
- Pregnancy
- Pacemaker
- Lack of ability to understand information given
- Prior resection of the colon/rectum
- Demanding analgetics prior to start of procedure
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 |
|---|---|---|
| 3D-imagerAlso: Skopguide3D-imager vs fluoroscopy during coloscopy | Device | – |
Primary outcome
pain during coloscopy
Time frame: instant
Time used to reach the coecum
Time frame: instant
6 secondary outcomes
coecum-intubation rate
Time frame: instant
level achieved when the coecum can not be reached
Time frame: instant
Need for assistance by a colleague
Time frame: instant
Need for analgetics
Time frame: instant
Pain during the first 24 hours after coloscopy
Time frame: 24 hours
Polyp detection rate
Time frame: instant
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 18 Aug 2011.
- Derived from this study: PubMed 21481862Holme O, Hoie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8.
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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.
Geir S Hoff, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3D-imager in people with Pain During Colonoscopy, run by Sorlandet Hospital HF 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 18 Aug 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 during coloscopy (time frame: instant). The study lists 2 primary outcomes in all. 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 NCT00519129, 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 18 Aug 2011.