Colonoscopic Surgical ProceduresNCT02109536
The Use of Magnetic Endoscopic Imagers During Colonoscopy for Loop Recognition and Resolution
An observational study of Colonoscopic Surgical Procedures, run by Lawrence Charles Hookey at 1 site in Canada.
Trial summary
The purpose of this study is threefold. First, the ability of experienced colonoscopists to recognize the type of loop formed will be assessed and whether the use of the MEI improves this accuracy. Second, to determine which maneuvers are used for loop reduction and whether certain loops have set ways to reduce them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopic Surgical Procedures
- What is being tested?
- Magnetic endoscopic imager.
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to 8 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive male and female patients, 18 years or older, undergoing outpatient colonoscopy in the MEI room at Hotel Dieu Hospital in Kingston, Ontario, Canada will be considered for the study.
Who may be able to join
- adults (18 years and older) undergoing colonoscopy
Who cannot join
- age less than 18 years old
- not willing to participate
- cardiac pacemaker
- internal cardiac defibrillator
- previous colonic surgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is threefold. First, the ability of experienced colonoscopists to recognize the type of loop formed will be assessed and whether the use of the MEI improves this accuracy. Second, to determine which maneuvers are used for loop reduction and whether certain loops have set ways to reduce them. The third component will assess whether the colonoscopist thought that the imager helped or not.
- Conditions
- Colonoscopic Surgical Procedures
- Being tested
- Magnetic endoscopic imager.
- Keywords
- Colonoscopy, Looping, Loop recognition, magnetic endoscopic imager
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic endoscopic imager.Device
recognizing loop type accuracy of loop type detection methods of loop reduction assessed by type
| Study group | Role | What they receive |
|---|---|---|
| Staff Gastroenterologists. | Staff Gastroenterologists ability to recognize loops will be assessed using an magnetic endoscopic imager. Receives: Device: Magnetic endoscopic imager. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of loop recognition by experienced colonoscopists compared to the magnetic imager.
When an endoscopist encounters looping they will verbalize what type of loop they think they have and this will be recorded by the endoscopy nurse on a pre-printed data collection sheet. The magnetic imager will then be turned on and a photo of the imager loop will be saved. A physician not involved with the colonoscopy will compare the image to the endoscopist's answer to determine whether they were correct or incorrect.
Measured: within 3 mths
Secondary outcomes (1)
Qualitative description of maneuvers used for loop reduction.
When an endoscopist encounters looping they will verbalize what type of loop they think they have and what maneuvers (example, reducing with clockwise torque) they used to reduce the loop. The magnetic imager will be turned on and the endoscopist will comment on whether the imager was helpful in reducing the loop. This information will be collected on a pre-printed data collection sheet.
Measured: within 3 mths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completion8 Dec 2018
- Study completion8 Dec 2018
Why it stopped: As the study progressed, the intervention became more of a standard of care, thus the study has stalled and been aborted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopic Surgical ProceduresStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lawrence Charles Hookey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lawrence Charles Hookey, Queen's University
- Investigators
- Aman V Arya, MD, Principal investigator, Queen's University, GIDRULawrence Hookey, MD, Principal investigator, Queen's University, GIDRUStephen Vanner, MD, Principal investigator, Queen's University, GIDRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109536
- Sponsor's protocol ID
- DMED-1639-13
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2014
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Magnetic Endoscopic Imagers During Colonoscopy for Loop Recognition and Resolution
- ClinicalTrials.gov ID
- NCT02109536
- Acronym / sponsor ID
- DMED-1639-13
- Conditions
- Colonoscopic Surgical Procedures
- Keywords
- Colonoscopy, Looping, Loop recognition, magnetic endoscopic imager
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: As the study progressed, the intervention became more of a standard of care, thus the study has stalled and been aborted.
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Lawrence Charles HookeyUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 8 Dec 2018 (actual)
- Study completion
- 8 Dec 2018 (actual)
- First posted
- 10 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.
The purpose of this study is threefold. First, the ability of experienced colonoscopists to recognize the type of loop formed will be assessed and whether the use of the MEI improves this accuracy. Second, to determine which maneuvers are used for loop reduction and whether certain loops have set ways to reduce them. The third component will assess whether the colonoscopist thought that the imager helped or not.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Staff Gastroenterologists. | – | Device: Magnetic endoscopic imager.Staff Gastroenterologists ability to recognize loops will be assessed using an magnetic endoscopic imager. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive male and female patients, 18 years or older, undergoing outpatient colonoscopy in the MEI room at Hotel Dieu Hospital in Kingston, Ontario, Canada will be considered for the study.
Key inclusion criteria (1 listed)
- adults (18 years and older) undergoing colonoscopy
Key exclusion criteria (5 listed)
- age less than 18 years old
- not willing to participate
- cardiac pacemaker
- internal cardiac defibrillator
- previous colonic surgery
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 endoscopic imager.recognizing loop type accuracy of loop type detection methods of loop reduction assessed by type | Device | Staff Gastroenterologists. |
Primary outcome
Accuracy of loop recognition by experienced colonoscopists compared to the magnetic imager.
Time frame: within 3 mths
When an endoscopist encounters looping they will verbalize what type of loop they think they have and this will be recorded by the endoscopy nurse on a pre-printed data collection sheet. The magnetic imager will then be turned on and a photo of the imager loop will be saved. A physician not involved with the colonoscopy will compare the image to the endoscopist's answer to determine whether they were correct or incorrect.
1 secondary outcome
Qualitative description of maneuvers used for loop reduction.
Time frame: within 3 mths
Results and safety
The study was stopped early (reason given: As the study progressed, the intervention became more of a standard of care, thus the study has stalled and been aborted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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.
Aman V Arya, MD principal investigator
Queen's University, GIDRU
Lawrence Hookey, MD principal investigator
Queen's University, GIDRU
Stephen Vanner, MD principal investigator
Queen's University, GIDRU
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 Colonoscopic Surgical Procedures, run by Lawrence Charles Hookey at 1 site in Canada.
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: stopped early, as of the sponsor's last update on 3 Feb 2021. 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 Canada. 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 was stopped early (reason given: As the study progressed, the intervention became more of a standard of care, thus the study has stalled and been aborted.). Results are not available in the source record.
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?
Accuracy of loop recognition by experienced colonoscopists compared to the magnetic imager. (time frame: within 3 mths). 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 3 Feb 2021.