ColonoscopyNCT01055782
Colonoscopy Endoguide in Specialist Practice
A study testing Endoguide in people with Colonoscopy and Pain, run by The Specialist Doctors at Rolighedsvej at 1 site in Denmark.
Trial summary
The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with or without endoguide. The study will investigate whether the endoguide improves success rate and the patient's perception of pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Pain
- What is being tested?
- Endoguide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,004 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Informed consent provided
Who cannot join
- Informed consent not provided or not possible to obtain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kan Anvendelse af Endoskopisk Positioneringsudstyr Ved coloskopiundersøgelsen (kikkertundersøgelse af Tarmen) i en højt Specialiseret Praksis Forbedre Patientens Subjektive Kvalitetsoplevelse (Smerteperception)?
The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with or without endoguide.
The study will investigate whether the endoguide improves success rate and the patient's perception of pain.
- Conditions
- Colonoscopy, Pain
- Being tested
- Endoguide
- Keywords
- Colonoscopy, Endoguide, Pain perception, Colonoscopy to the coecum (success rate), Patient's perception of pain, Duration of successful colonoscopies
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoguideDevice
Use of endoguide to facilitate completion of endoscopy
| Study group | Role | What they receive |
|---|---|---|
| With endoguide | Experimental | Colonoscopy completed with endoguide Receives: Device: Endoguide |
| Without endoguide | No intervention | Colonoscopy completed without endoguide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completed Colonoscopy
Measured: immediately after colonoscopy
Secondary outcomes (1)
Perception of Pain
VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale
Measured: After endoscopy (within 10mins) and 1 day after endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionApr 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Specialist Doctors at Rolighedsvej
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Medical Association, Surgical Clinic, Allerød, Denmark
- Responsible party
- Principal investigator, Lene Hendel, The Specialist Doctors at Rolighedsvej
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055782
- Sponsor's protocol ID
- H-1-2009-80
- Status last verified
- Jun 2012
- First submitted
- 24 Jan 2010
- Last updated
- 11 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bak-Christensen A, Knudsen E, Hendel J, Ifaoui IB, Lehrskov-Schmidt L, Hendel L. Colonoscopy results are not enhanced by use of magnet endoguide in specialist practice. Dan Med J. 2013 Jun;60(6):A4611.
PubMed 23743108
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kan Anvendelse af Endoskopisk Positioneringsudstyr Ved coloskopiundersøgelsen (kikkertundersøgelse af Tarmen) i en højt Specialiseret Praksis Forbedre Patientens Subjektive Kvalitetsoplevelse (Smerteperception)?
- ClinicalTrials.gov ID
- NCT01055782
- Acronym / sponsor ID
- H-1-2009-80
- Conditions
- Colonoscopy, Pain
- Keywords
- Colonoscopy, Endoguide, Pain perception, Colonoscopy to the coecum (success rate), Patient's perception of pain, Duration of successful colonoscopies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- The Specialist Doctors at RolighedsvejUniversity, hospital or other
- Collaborators
- Danish Medical Association, Surgical Clinic, Allerød, Denmark
- Study start
- Nov 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 28 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with or without endoguide.
The study will investigate whether the endoguide improves success rate and the patient's perception of pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With endoguide | Experimental | Device: EndoguideColonoscopy completed with endoguide |
| Without endoguide | No intervention | –Colonoscopy completed without endoguide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Informed consent provided
Key exclusion criteria (1 listed)
- Informed consent not provided or not possible to obtain
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 |
|---|---|---|
| EndoguideUse of endoguide to facilitate completion of endoscopy | Device | With endoguide |
Primary outcome
Completed Colonoscopy
Time frame: immediately after colonoscopy
1 secondary outcome
Perception of Pain
Time frame: After endoscopy (within 10mins) and 1 day after endoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23743108Bak-Christensen A, Knudsen E, Hendel J, Ifaoui IB, Lehrskov-Schmidt L, Hendel L. Colonoscopy results are not enhanced by use of magnet endoguide in specialist practice. Dan Med J. 2013 Jun;60(6):A4611.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoguide in people with Colonoscopy and Pain, run by The Specialist Doctors at Rolighedsvej at 1 site in Denmark.
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 1 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 11 Jun 2012. 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 Denmark. 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?
Yes. Results are posted in the registry (first posted 28 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Completed Colonoscopy (time frame: immediately after colonoscopy). 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 NCT01055782, 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 11 Jun 2012.