Sensitivity Training GroupsNCT01997177
Assessment of Competence in Colonoscopy Using Motion Capture
An observational study of Sensitivity Training Groups, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Aim: To study the basic technical skills of colonoscopy using a MS Kinect for motion analysis. In order to develop a non-biased tool to monitor competence. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity Training Groups
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2013to Nov 2013
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Doctors in gastroenterology
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Aim: To study the basic technical skills of colonoscopy using a MS Kinect for motion analysis. In order to develop a non-biased tool to monitor competence.
Read the detailed description
To compare a group of novices to a group of experienced endoscopists performining colonoscopy.
Analyzing the motion pattern of the performers using a Kinect. Use the contrasting group method to set standards.
- Conditions
- Sensitivity Training Groups
- Keywords
- simulation, training, colonoscopy, standard setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| novices | novice endoscopists, fellows of gastroenterology | |
| experienced endoscopist | consultant doctors of gastroenterology |
What is being measured
The primary outcome is the main question the study is designed to answer.
to identify metrics of importans in colonoscopy training program
testing colonoscopy competence in a simulation lab. Finding metrics with discriminatory ability.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionNov 2013
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 Sensitivity Training GroupsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Preisler, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Louise Preisler, MD, Principal investigator, CEKU, Centre of clinical education, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997177
- Sponsor's protocol ID
- motion capture in colonoscopy
- Status last verified
- Nov 2013
- First submitted
- 22 Nov 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Preisler L, Sondergaard Svendsen MB, Sondergaard B, Brink L, Nordentoft T, Svendsen LB, Konge L. Automatic and unbiased assessment of competence in colonoscopy: exploring validity of the Colonoscopy Progression Score (CoPS). Endosc Int Open. 2016 Dec;4(12):E1238-E1243. doi: 10.1055/s-0042-118226. Epub 2016 Nov 17.
PubMed 27995182
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Competence in Colonoscopy Using Motion Capture
- ClinicalTrials.gov ID
- NCT01997177
- Acronym / sponsor ID
- motion capture in colonoscopy
- Conditions
- Sensitivity Training Groups
- Keywords
- simulation, training, colonoscopy, standard setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Nov 2013 (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.
Aim: To study the basic technical skills of colonoscopy using a MS Kinect for motion analysis. In order to develop a non-biased tool to monitor competence.
Detailed description
To compare a group of novices to a group of experienced endoscopists performining colonoscopy.
Analyzing the motion pattern of the performers using a Kinect. Use the contrasting group method to set standards.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| novices | – | –novice endoscopists, fellows of gastroenterology |
| experienced endoscopist | – | –consultant doctors of gastroenterology |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Doctors in gastroenterology
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to identify metrics of importans in colonoscopy training program
Time frame: 3 months
testing colonoscopy competence in a simulation lab. Finding metrics with discriminatory ability.
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 27 Nov 2013.
- Derived from this study: PubMed 27995182Preisler L, Sondergaard Svendsen MB, Sondergaard B, Brink L, Nordentoft T, Svendsen LB, Konge L. Automatic and unbiased assessment of competence in colonoscopy: exploring validity of the Colonoscopy Progression Score (CoPS). Endosc Int Open. 2016 Dec;4(12):E1238-E1243. doi: 10.1055/s-0042-118226. Epub 2016 Nov 17.
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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.
Louise Preisler, MD principal investigator
CEKU, Centre of clinical education, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensitivity Training Groups, run by Copenhagen University Hospital, Rigshospitalet 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 0 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 27 Nov 2013. 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?
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?
to identify metrics of importans in colonoscopy training program (time frame: 3 months). 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 NCT01997177, 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 27 Nov 2013.