Vaginal HysterectomyNCT05418764
Effect of Validated Skills Simulation With the Miya Model
A study testing Miyamodel Training in people with Vaginal Hysterectomy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Simulation training with the Miya Model will improve Operating Room performance of Vaginal Hysterectomy (VH) in novice surgeons and this phase of the study is designed to test that. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaginal Hysterectomy
- What is being tested?
- Miyamodel Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2021to 13 Oct 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- residents at participating Institutions
- residents have performed ten or fewer vaginal hysterectomies
Who cannot join
- having had prior training dedicated to vaginal hysterectomy
- having performed eleven or more vaginal hysterectomies in the OR
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Effect of Validated Skills Simulation With the Miya Model on Operating Room Performance of Vaginal Hysterectomy
Simulation training with the Miya Model will improve Operating Room performance of Vaginal Hysterectomy (VH) in novice surgeons and this phase of the study is designed to test that.
Read the detailed description
Vaginal Hysterectomy (VH) is the desired hysterectomy technique of The American College of Obstetricians and Gynecologists (ACOG) since it is associated with less morbidity, quicker recovery and lower costs than laparoscopic and abdominal hysterectomy. Despite its well documented advantages, numbers nationwide in the US are declining. Of all minimally invasive hysterectomy procedures, the vaginal approach has been the only one demonstrating a consistent decrease in use from 25% of cases in 1998 to 17% of cases in 2010. A large part of this is due to inadequate training for this technique. There currently is no standardized curriculum for teaching VH, and training varies widely between residency programs. It is widely held that simulation training for surgical procedures improves outcome, but there is a need to validate this for vaginal surgery training.
- Conditions
- Vaginal Hysterectomy
- Being tested
- Miyamodel Training
- Keywords
- vaginal surgery techniques, gynecological procedures, mid-urethral slings (MUS), simulation training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miyamodel TrainingOther
standardized training by performing five hysterectomies on the Miyamodel with a trainer who is a sub-PI at each institution
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive standardized training by performing five hysterectomies on the Miya Model with a trainer who is a sub-PI at each Institution, with each of these training sessions filmed and then scored by blinded experts - Residents in the simulation arm will train until they reach a score of 27 on the modified Vagina Surgical Skills Index (VSSI) Receives: Other: Miyamodel Training |
| Control group | No intervention | The training will be whatever is standard at their Institution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Surgical Skills Index (VSSI) scores - Control Group
compare scores between the control and intervention group to see if the standardized simulation training improves OR performance - Range 0 - 40; higher score indicates better performance
Measured: Month 2
Vaginal Surgical Skills Index (VSSI) scores - Intervention Group
compare scores between the control and intervention group to see if the standardized simulation training improves OR performance - Range 0 - 40; higher score indicates better performance
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start27 Dec 2021
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HysterectomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be residents at participating institutions who agree to participate in the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Kammire, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418764
- Sponsor's protocol ID
- IRB00072056
- Status last verified
- Jul 2025
- First submitted
- 9 Jun 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Validated Skills Simulation With the Miya Model on Operating Room Performance of Vaginal Hysterectomy
- ClinicalTrials.gov ID
- NCT05418764
- Acronym / sponsor ID
- IRB00072056
- Conditions
- Vaginal Hysterectomy
- Keywords
- vaginal surgery techniques, gynecological procedures, mid-urethral slings (MUS), simulation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 14 Jun 2022 (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.
Simulation training with the Miya Model will improve Operating Room performance of Vaginal Hysterectomy (VH) in novice surgeons and this phase of the study is designed to test that.
Detailed description
Vaginal Hysterectomy (VH) is the desired hysterectomy technique of The American College of Obstetricians and Gynecologists (ACOG) since it is associated with less morbidity, quicker recovery and lower costs than laparoscopic and abdominal hysterectomy. Despite its well documented advantages, numbers nationwide in the US are declining. Of all minimally invasive hysterectomy procedures, the vaginal approach has been the only one demonstrating a consistent decrease in use from 25% of cases in 1998 to 17% of cases in 2010. A large part of this is due to inadequate training for this technique. There currently is no standardized curriculum for teaching VH, and training varies widely between residency programs. It is widely held that simulation training for surgical procedures improves outcome, but there is a need to validate this for vaginal surgery training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study participants will be residents at participating institutions who agree to participate in the study.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Miyamodel TrainingParticipants will receive standardized training by performing five hysterectomies on the Miya Model with a trainer who is a sub-PI at each Institution, with each of these training sessions filmed and then scored by blinded experts - Residents in the simulation arm will train until they reach a score of 27 on the modified Vagina Surgical Skills Index (VSSI) |
| Control group | No intervention | –The training will be whatever is standard at their Institution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- residents at participating Institutions
- residents have performed ten or fewer vaginal hysterectomies
Key exclusion criteria (2 listed)
- having had prior training dedicated to vaginal hysterectomy
- having performed eleven or more vaginal hysterectomies in the OR
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 |
|---|---|---|
| Miyamodel Trainingstandardized training by performing five hysterectomies on the Miyamodel with a trainer who is a sub-PI at each institution | Other | Intervention group |
Primary outcome
Vaginal Surgical Skills Index (VSSI) scores - Control Group
Time frame: Month 2
compare scores between the control and intervention group to see if the standardized simulation training improves OR performance - Range 0 - 40; higher score indicates better performance
Vaginal Surgical Skills Index (VSSI) scores - Intervention Group
Time frame: Month 2
compare scores between the control and intervention group to see if the standardized simulation training improves OR performance - Range 0 - 40; higher score indicates better 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 1 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Leslie Kammire, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miyamodel Training in people with Vaginal Hysterectomy, run by Wake Forest University Health Sciences 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 2 inclusion and 2 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 1 Apr 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?
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?
Vaginal Surgical Skills Index (VSSI) scores - Control Group (time frame: Month 2). 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?
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 1 Apr 2026.