Impact of Supervision on Endoscopy Simulation CurriculumNCT03495141
Outcomes in Simulated Endoscopy Training
A study testing Supervision/Coaching in people with Impact of Supervision on Endoscopy Simulation Curriculum, run by University of Oklahoma at 1 site in United States.
Trial summary
Eligible participants are those who are members of the general surgery residency pediatric gastroenterology fellowship, and adult gastroenterology fellowship. Through a randomized-controlled trial, participants will fill out a baseline set of demographic information including year of training, approximate number of… Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Impact of Supervision on Endoscopy Simulation Curriculum
- What is being tested?
- Supervision/Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consenting trainees of adult and pediatric gastroenterology fellowships and general surgery residencies at the University of Oklahoma Health Sciences Center.
Who cannot join
- Unwilling to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Samantha Harbert, 405-271-2045, Samantha-Harbert@ouhsc.edu
About this study
Official title: Simbionix GI Mentor Simulated Endoscopy Training
Eligible participants are those who are members of the general surgery residency pediatric gastroenterology fellowship, and adult gastroenterology fellowship. Through a randomized-controlled trial, participants will fill out a baseline set of demographic information including year of training, approximate number of colonoscopies to date, specialty, age, sex and handedness. Participation in this activity is completely voluntary. Trainees will be randomized to one of two groups. Either first participating in an unassisted colonoscopy module twice and then taking a questionnaire and then transitioning to a supervised/coached colonoscopy module session twice and taking a questionnaire, versus the reverse, in which the participant first partakes in a supervised/coached colonoscopy module session twice and then transitions to performing a colonoscopy module twice, unassisted. Objective measures will be assessed by the module software and supervising faculty. Specifically, using individuals' survey responses to see if early supervision improves survey scores. Survey questions focus on student learning, completing module objectives and faculty performance in simulation. The survey will also ask subjects to self-rate their scores and comfort level with endoscopy skills. Survey responses will not be linked to an individuals' performance in their program training and endoscopy coaches will not be made aware of the survey responses.
Read the detailed description
This will be a randomized controlled trial in which eligible participants will be members of the general surgery residency and adult gastroenterology fellowship. Investigators will ask all consenting participants to fill out a baseline set of demographic information including their year of training, the approximate number of colonoscopies to date, specialty, age, sex and dominant-handedness. Additional questions to be asked will inquire about the participant's experience in regard to the unassisted and supervision/coached colonoscopy module experience. Participation in this activity is completely voluntary, and the participating trainee is under no obligation to complete or finish the simulation or subsequent surveys The participant will be randomized to one of two groups. A computer program will make this random assignment. Neither the participant nor their physician coach will be able to choose which group they will be in. Participants will either first partake in an unassisted colonoscopy module twice (case one and case two) and then transition to a supervised/coached colonoscopy module session twice (case three and case four). The alternative is in which the participant first partakes in a supervised/coached colonoscopy module session twice (case one and case two) and then transitions to performing an unassisted colonoscopy module twice (case three and case four). A questionnaire examining training experience will be administered after case # 4 in both groups. This survey will take approximately 5 minutes to complete. Other objective measures will be assessed by supervising faculty and other metrics acquired through the simulator software. Individuals' survey responses will be used to see if early supervision improves trainee satisfaction and perceptions on survey scores. Participants will attend one individual training session date that will satisfy the designed simulation experience. The trainee can stop participating in this study at any time and participation in the study is voluntary and trainees may choose not to participate. It is important to note that refusal to participate will not affect a learner's access to the training center and will not affect their standing in their respective training program. The results will not be included in their official training record. Note no prior procedural or technical knowledge is required. Enrollment will continue for the 2018-2019 academic year and possibly academic years thereafter.
- Being tested
- Supervision/Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervision/CoachingBehavioural
Supervision involves coaching the trainee on insertion and withdrawal technique in a standard colonoscopy in a novice trainee
| Study group | Role | What they receive |
|---|---|---|
| Supervised | Active comparator | Participants first take part in supervised/coached colonoscopy module session twice (case one and case two) and then transition to performing an unassisted colonoscopy module twice (case three and case four). Receives: Behavioral: Supervision/Coaching |
| Unsupervised | Active comparator | Participants will either first partake in an unsupervised colonoscopy module twice (case one and case two) and then transition to a supervised/coached colonoscopy module session twice (case three and case four). Receives: Behavioral: Supervision/Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of mucosa inspected
The primary outcome will be the difference in percentage of mucosa inspected between the two study groups based on the report of the simulator after each of 4 predefined cases
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Time to reach cecum
Time to reach cecum after time of colonoscope insertion
Measured: through study completion, an average of 1 year
Participant satisfaction score
Participants will be asked to self-report satisfaction with supervised and unsupervised endoscopic simulator experiences
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start6 Mar 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Supervision on Endoscopy Simulation CurriculumStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Tierney, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495141
- Sponsor's protocol ID
- 8244Exempt
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2018
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will only be known to PI and co-investigator (this writer) and de-identified data will be used for statistical analysis.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simbionix GI Mentor Simulated Endoscopy Training
- ClinicalTrials.gov ID
- NCT03495141
- Acronym / sponsor ID
- 8244Exempt
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Apr 2018 (actual)
- 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.
Eligible participants are those who are members of the general surgery residency pediatric gastroenterology fellowship, and adult gastroenterology fellowship. Through a randomized-controlled trial, participants will fill out a baseline set of demographic information including year of training, approximate number of colonoscopies to date, specialty, age, sex and handedness. Participation in this activity is completely voluntary. Trainees will be randomized to one of two groups. Either first participating in an unassisted colonoscopy module twice and then taking a questionnaire and then transitioning to a supervised/coached colonoscopy module session twice and taking a questionnaire, versus the reverse, in which the participant first partakes in a supervised/coached colonoscopy module session twice and then transitions to performing a colonoscopy module twice, unassisted. Objective measures will be assessed by the module software and supervising faculty. Specifically, using individuals' survey responses to see if early supervision improves survey scores. Survey questions focus on student learning, completing module objectives and faculty performance in simulation. The survey will also ask subjects to self-rate their scores and comfort level with endoscopy skills. Survey responses will not be linked to an individuals' performance in their program training and endoscopy coaches will not be made aware of the survey responses.
Detailed description
This will be a randomized controlled trial in which eligible participants will be members of the general surgery residency and adult gastroenterology fellowship. Investigators will ask all consenting participants to fill out a baseline set of demographic information including their year of training, the approximate number of colonoscopies to date, specialty, age, sex and dominant-handedness. Additional questions to be asked will inquire about the participant's experience in regard to the unassisted and supervision/coached colonoscopy module experience. Participation in this activity is completely voluntary, and the participating trainee is under no obligation to complete or finish the simulation or subsequent surveys The participant will be randomized to one of two groups. A computer program will make this random assignment. Neither the participant nor their physician coach will be able to choose which group they will be in. Participants will either first partake in an unassisted colonoscopy module twice (case one and case two) and then transition to a supervised/coached colonoscopy module session twice (case three and case four). The alternative is in which the participant first partakes in a supervised/coached colonoscopy module session twice (case one and case two) and then transitions to performing an unassisted colonoscopy module twice (case three and case four). A questionnaire examining training experience will be administered after case # 4 in both groups. This survey will take approximately 5 minutes to complete. Other objective measures will be assessed by supervising faculty and other metrics acquired through the simulator software. Individuals' survey responses will be used to see if early supervision improves trainee satisfaction and perceptions on survey scores. Participants will attend one individual training session date that will satisfy the designed simulation experience. The trainee can stop participating in this study at any time and participation in the study is voluntary and trainees may choose not to participate. It is important to note that refusal to participate will not affect a learner's access to the training center and will not affect their standing in their respective training program. The results will not be included in their official training record. Note no prior procedural or technical knowledge is required. Enrollment will continue for the 2018-2019 academic year and possibly academic years thereafter.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised | Active comparator | Behavioral: Supervision/CoachingParticipants first take part in supervised/coached colonoscopy module session twice (case one and case two) and then transition to performing an unassisted colonoscopy module twice (case three and case four). |
| Unsupervised | Active comparator | Behavioral: Supervision/CoachingParticipants will either first partake in an unsupervised colonoscopy module twice (case one and case two) and then transition to a supervised/coached colonoscopy module session twice (case three and case four). |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Consenting trainees of adult and pediatric gastroenterology fellowships and general surgery residencies at the University of Oklahoma Health Sciences Center.
Key exclusion criteria (1 listed)
- Unwilling to consent.
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 |
|---|---|---|
| Supervision/CoachingSupervision involves coaching the trainee on insertion and withdrawal technique in a standard colonoscopy in a novice trainee | Behavioural | Supervised, Unsupervised |
Primary outcome
Percentage of mucosa inspected
Time frame: through study completion, an average of 1 year
The primary outcome will be the difference in percentage of mucosa inspected between the two study groups based on the report of the simulator after each of 4 predefined cases
2 secondary outcomes
Time to reach cecum
Time frame: through study completion, an average of 1 year
Participant satisfaction score
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No. Participant data will only be known to PI and co-investigator (this writer) and de-identified data will be used for statistical analysis.
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.
William Tierney, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervision/Coaching in people with Impact of Supervision on Endoscopy Simulation Curriculum, run by University of Oklahoma at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Tierney, MD (405-271-5428, William-Tierney@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of mucosa inspected (time frame: through study completion, an average of 1 year). 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 30 Jul 2026.