Colonic DiseasesNCT02681692
Effect of Magnetic Endoscopic Imaging on Patient Pain During Colonoscopy
A study testing Magnetic endoscopic imaging system in people with Colonic Diseases, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Colonoscopy is widely considered as the main choice for patients with suspected colorectal disease,and for screening those at high risk of colorectal cancer. However， colonoscope examination,especially those unsedated ones for screening,may bring much pain to patients,even induce some severe complications such as… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonic Diseases
- What is being tested?
- Magnetic endoscopic imaging system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to May 2017
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colonoscopists: All colonoscopists are selected from the colonoscopy learners in Endoscopy Center of Shanghai Renji Hospital. Only inexperienced colonoscopists (having performed less than 200 procedures) would be allowed to participate in the first part while both inexperienced colonoscopists and experienced colonoscopists (having performed less than 350 procedures) are allowed to participate in the second part.
- patients: in the first part: Patients aged between 18 and 75 are recruited to receive unsedated colonoscopy examination with their permission. Written informed consent would be obtained.
- in the second part:no patient would participate in this part
- Exclusion Criteria： patients:consecutive patients,excluding inpatients,pregnant,who had a known or suspected colonic stricture or obstruction, who had previous history of abdominal surgery,who had severe comorbid cardiopulmonary,kidney,liver conditions,who had pacemakers or internal defibrillators,who were unable to give informed consent,who have active gastrointestinal bleeding are recruited
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Effect of Magnetic Endoscopic Imaging on Patient Pain During Colonoscopy: a Randomized, Controlled Trial Using a Simple Colon Force Measurement Device
Colonoscopy is widely considered as the main choice for patients with suspected colorectal disease,and for screening those at high risk of colorectal cancer. However， colonoscope examination,especially those unsedated ones for screening,may bring much pain to patients,even induce some severe complications such as perforation.Considering the increasing need of colonoscopy examination for screening purpose,it has been a problem deserving of further study that how to reduce pain and ensure safety during the procedure.Some studies suggest that use of Magnetic endoscopic imaging(MEI) during colonoscopy has the potential to ease patient discomfort and reduce complications.Theoretically,the MEI could accurately depict the position of the scope in three dimensions and help avoid forcefully feeding the colonoscope through loops of vulnerable bowel,thus alleviating patient pain and promoting procedure safety.However,the problem whether MEI system could help reduce patient pain during procedure effectively，especially in inexperienced colonoscopists，still remains controversial for researchers,and no study has been designed to test the hypothesis that MEI may help decrease the risk of some complications,such as colon perforation.In this study we aim to evaluate the he efficacy of magnetic scope navigation on patient pain during unsedated colonoscopy；In addition，we try to construct a simple colon force measurement device ,and by using this device to observe the variation of force exerted on colon loop ,we expect to find the potential mechanism of pain-alleviation and explore the possible effect of complication reduction during colonoscopy under the influence of MEI system.
Read the detailed description
This clinical trial is planned as two parts:In the first part,consecutive patients would be recruited and randomized to have colonoscopy examination performed by inexperienced colonoscopists (having performed less than 200 procedures) either with or without the assistance of magnetic scope navigation system. The second part would be conducted as a pilot study,we would first construct a simple colon force measurement device;then colonoscopist would be randomized to perform colonoscopy on a colon model either with or without an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. All force variation data would be recorded by a image storage device.No patients would be involved in the second part.In this pilot study, we plan to perform 40 colonoscopy procedures with the assistance of MEI and 40 colonoscopy procedures without the assistance of MEI.
- Conditions
- Colonic Diseases
- Being tested
- Magnetic endoscopic imaging system
- Keywords
- colonoscopy, colonoscopy education, magnetic endoscope imaging, Colonic Diseases
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic endoscopic imaging systemDevice
Also called magnetic scope navigation system., MEI system
In the first part,patients would be randomly assigned to have colonoscopy examination performed by one inexperienced colonoscopist (having performed less than 200 procedures) with the assistance of magnetic scope navigation system In the second part colonoscopist would be randomized to perform conventional colonoscopy on a colon model with an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. No patients would be involved in this part. All force variation data would be recorded by a image storage device.
| Study group | Role | What they receive |
|---|---|---|
| MEI colonoscopy Group | Active comparator | Patients would be randomly assigned to have colonoscopy examination performed by one inexperienced colonoscopist (having performed less than 200 procedures) with the assistance of magnetic scope navigation system Receives: Device: Magnetic endoscopic imaging system |
| Standard colonoscopy Group | No intervention | Patients would be randomly assigned to have colonoscopy examination performed by one inexperienced colonoscopist (having performed less than 200 procedures) without the assistance of magnetic scope navigation system |
| MEI colon model Group | Active comparator | Colonoscopist would be randomized to perform colonoscopy on a colon model with an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. No patients would be involved in this part.
All force variation data would be recorded by a image storage device. Receives: Device: Magnetic endoscopic imaging system |
| Standard colon model Group | No intervention | Colonoscopist would be randomized to perform conventional colonoscopy on a colon model without an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. No patients would be involved in this part. All force variation data would be recorded by a image storage device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients over pain experience
A pain score would be obtained from patients shortly after each examination. The score would be obtained with the Help of a visual analogue scale ranging from 0(no pain)to10(the worst pain).
Measured: day of colonoscope performance
Maximum target colon loop force
In the second part,The maximum colon force exerted on a chosen target colon loop （we plan to choose one loop of sigmoid colon）would be recorded by the simple colon force measurement device.
Measured: day of colonoscope performance
Secondary outcomes (7)
number of attempts of abdominal hand pressure
Measured: day of colonoscope performance
number of patient reposition
Measured: day of colonoscope performance
endoscopist perception of ease of procedure
Endoscopist are asked to score the ease of each procedure after completion,using a ten-point scoring system(ease-of-procedure score)form 0(easiest)to 10(most difficult).
Measured: day of colonoscope performance
patient's intention to attend unsedated colonoscopy again
patients need to answer "yes"or"no"
Measured: day of colonoscope performance
caecal intubation rate
Criteria for reaching the caecum are identification of the ileocaecal valve
Measured: one year
caecal intubation time
Measured: day of colonoscope performance
ime for the colonoscopist to advance to splenic flexure of colon
In the second part，time for the colonoscopist to advance to splenic flexure of colon would be recorded.
Measured: day of colonoscope performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681692
- Sponsor's protocol ID
- rj（2015）086k
- Status last verified
- Jun 2018
- First submitted
- 10 Feb 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Continuing Medical Education Exam: September 2014 James Buxbaum, MD, William Ross, MD, Shou-Jiang Tang, MD, Brian Weston, MD,Co-Editors, CME Section G. S. Raju, MD,Editor, CME Section Glenn M. Eisen, MD, MPH,Editor-in-Chief, Gastrointestinal Endoscopy 503.e1， GASTROINTESTINAL ENDOSCOPY Volume 80, No. 3 : 2014
Hoff G, Bretthauer M, Dahler S, Huppertz-Hauss G, Sauar J, Paulsen J, Seip B, Moritz V. Improvement in caecal intubation rate and pain reduction by using 3-dimensional magnetic imaging for unsedated colonoscopy: a randomized trial of patients referred for colonoscopy. Scand J Gastroenterol. 2007 Jul;42(7):885-9. doi: 10.1080/00365520601127125.
PubMed 17558914Shah SG, Brooker JC, Williams CB, Thapar C, Saunders BP. Effect of magnetic endoscope imaging on colonoscopy performance: a randomised controlled trial. Lancet. 2000 Nov 18;356(9243):1718-22. doi: 10.1016/S0140-6736(00)03205-0.
PubMed 11095259Kaltenbach T, Leung C, Wu K, Yan K, Friedland S, Soetikno R. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011 May;56(5):1496-502. doi: 10.1007/s10620-011-1614-1. Epub 2011 Mar 16.
PubMed 21409379
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnetic Endoscopic Imaging on Patient Pain During Colonoscopy: a Randomized, Controlled Trial Using a Simple Colon Force Measurement Device
- ClinicalTrials.gov ID
- NCT02681692
- Acronym / sponsor ID
- rj（2015）086k
- Conditions
- Colonic Diseases
- Keywords
- colonoscopy, colonoscopy education, magnetic endoscope imaging, Colonic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 594 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 12 Feb 2016 (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.
Colonoscopy is widely considered as the main choice for patients with suspected colorectal disease,and for screening those at high risk of colorectal cancer. However， colonoscope examination,especially those unsedated ones for screening,may bring much pain to patients,even induce some severe complications such as perforation.Considering the increasing need of colonoscopy examination for screening purpose,it has been a problem deserving of further study that how to reduce pain and ensure safety during the procedure.Some studies suggest that use of Magnetic endoscopic imaging(MEI) during colonoscopy has the potential to ease patient discomfort and reduce complications.Theoretically,the MEI could accurately depict the position of the scope in three dimensions and help avoid forcefully feeding the colonoscope through loops of vulnerable bowel,thus alleviating patient pain and promoting procedure safety.However,the problem whether MEI system could help reduce patient pain during procedure effectively，especially in inexperienced colonoscopists，still remains controversial for researchers,and no study has been designed to test the hypothesis that MEI may help decrease the risk of some complications,such as colon perforation.In this study we aim to evaluate the he efficacy of magnetic scope navigation on patient pain during unsedated colonoscopy；In addition，we try to construct a simple colon force measurement device ,and by using this device to observe the variation of force exerted on colon loop ,we expect to find the potential mechanism of pain-alleviation and explore the possible effect of complication reduction during colonoscopy under the influence of MEI system.
Detailed description
This clinical trial is planned as two parts:In the first part,consecutive patients would be recruited and randomized to have colonoscopy examination performed by inexperienced colonoscopists (having performed less than 200 procedures) either with or without the assistance of magnetic scope navigation system. The second part would be conducted as a pilot study,we would first construct a simple colon force measurement device;then colonoscopist would be randomized to perform colonoscopy on a colon model either with or without an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. All force variation data would be recorded by a image storage device.No patients would be involved in the second part.In this pilot study, we plan to perform 40 colonoscopy procedures with the assistance of MEI and 40 colonoscopy procedures without the assistance of MEI.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MEI colonoscopy Group | Active comparator | Device: Magnetic endoscopic imaging systemPatients would be randomly assigned to have colonoscopy examination performed by one inexperienced colonoscopist (having performed less than 200 procedures) with the assistance of magnetic scope navigation system |
| Standard colonoscopy Group | No intervention | –Patients would be randomly assigned to have colonoscopy examination performed by one inexperienced colonoscopist (having performed less than 200 procedures) without the assistance of magnetic scope navigation system |
| MEI colon model Group | Active comparator | Device: Magnetic endoscopic imaging systemColonoscopist would be randomized to perform colonoscopy on a colon model with an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. No patients would be involved in this part. All force variation data would be recorded by a image storage device. |
| Standard colon model Group | No intervention | –Colonoscopist would be randomized to perform conventional colonoscopy on a colon model without an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. No patients would be involved in this part. All force variation data would be recorded by a image storage device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- colonoscopists: All colonoscopists are selected from the colonoscopy learners in Endoscopy Center of Shanghai Renji Hospital. Only inexperienced colonoscopists (having performed less than 200 procedures) would be allowed to participate in the first part while both inexperienced colonoscopists and experienced colonoscopists (having performed less than 350 procedures) are allowed to participate in the second part.
- patients: in the first part: Patients aged between 18 and 75 are recruited to receive unsedated colonoscopy examination with their permission. Written informed consent would be obtained.
- in the second part:no patient would participate in this part
- Exclusion Criteria： patients:consecutive patients,excluding inpatients,pregnant,who had a known or suspected colonic stricture or obstruction, who had previous history of abdominal surgery,who had severe comorbid cardiopulmonary,kidney,liver conditions,who had pacemakers or internal defibrillators,who were unable to give informed consent,who have active gastrointestinal bleeding are recruited
Key exclusion criteria (0 listed)
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 imaging systemAlso: magnetic scope navigation system., MEI systemIn the first part,patients would be randomly assigned to have colonoscopy examination performed by one inexperienced colonoscopist (having performed less than 200 procedures) with the assistance of magnetic scope navigation system In the second part colonoscopist would be randomized to perform conventional colonoscopy on a colon model with an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. No patients would be involved in this part. All force variation data would be recorded by a image storage device. | Device | MEI colon model Group, MEI colonoscopy Group |
Primary outcome
patients over pain experience
Time frame: day of colonoscope performance
A pain score would be obtained from patients shortly after each examination. The score would be obtained with the Help of a visual analogue scale ranging from 0(no pain)to10(the worst pain).
Maximum target colon loop force
Time frame: day of colonoscope performance
In the second part,The maximum colon force exerted on a chosen target colon loop （we plan to choose one loop of sigmoid colon）would be recorded by the simple colon force measurement device.
7 secondary outcomes
number of attempts of abdominal hand pressure
Time frame: day of colonoscope performance
number of patient reposition
Time frame: day of colonoscope performance
endoscopist perception of ease of procedure
Time frame: day of colonoscope performance
patient's intention to attend unsedated colonoscopy again
Time frame: day of colonoscope performance
caecal intubation rate
Time frame: one year
caecal intubation time
Time frame: day of colonoscope performance
ime for the colonoscopist to advance to splenic flexure of colon
Time frame: day of colonoscope performance
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 2 Jul 2018.
- BackgroundContinuing Medical Education Exam: September 2014 James Buxbaum, MD, William Ross, MD, Shou-Jiang Tang, MD, Brian Weston, MD,Co-Editors, CME Section G. S. Raju, MD,Editor, CME Section Glenn M. Eisen, MD, MPH,Editor-in-Chief, Gastrointestinal Endoscopy 503.e1， GASTROINTESTINAL ENDOSCOPY Volume 80, No. 3 : 2014
- Background: PubMed 17558914Hoff G, Bretthauer M, Dahler S, Huppertz-Hauss G, Sauar J, Paulsen J, Seip B, Moritz V. Improvement in caecal intubation rate and pain reduction by using 3-dimensional magnetic imaging for unsedated colonoscopy: a randomized trial of patients referred for colonoscopy. Scand J Gastroenterol. 2007 Jul;42(7):885-9. doi: 10.1080/00365520601127125.
- Background: PubMed 11095259Shah SG, Brooker JC, Williams CB, Thapar C, Saunders BP. Effect of magnetic endoscope imaging on colonoscopy performance: a randomised controlled trial. Lancet. 2000 Nov 18;356(9243):1718-22. doi: 10.1016/S0140-6736(00)03205-0.
- Background: PubMed 21409379Kaltenbach T, Leung C, Wu K, Yan K, Friedland S, Soetikno R. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011 May;56(5):1496-502. doi: 10.1007/s10620-011-1614-1. Epub 2011 Mar 16.
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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 Magnetic endoscopic imaging system in people with Colonic Diseases, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 4 inclusion and 0 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 2 Jul 2018. 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 China. 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?
patients over pain experience (time frame: day of colonoscope performance). 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 NCT02681692, which also lists 4 linked publications.
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 2 Jul 2018.