Testicular Positioning AnomaliesPaTenSimNCT07106502
Learning to Palpate the Child's Testicles Using Simulation
A study testing testicular palpation training on a mannequin in people with Testicular Positioning Anomalies and Cryptorchidism, run by University Hospital, Angers.
Trial summary
Hypothesis is that better training of medical students in the examination of boy's external genitalia could improve the diagnosis of testicular position anomalies. To this end, investigators already have created a model to train testicle palpation and recognition of testicular position anomalies. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Testicular Positioning Anomalies, Cryptorchidism
- What is being tested?
- testicular palpation training on a mannequin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical student who volunteers to take part in the study during their pediatric or pediatric surgery clerkship or at the simulation center
Who cannot join
- student non in pediatric intership or non in pediatric surgery intership or non at the simulation center intership
- Student with previous simulation training in the examination of the external genitalia of children
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Hypothesis is that better training of medical students in the examination of boy's external genitalia could improve the diagnosis of testicular position anomalies. To this end, investigators already have created a model to train testicle palpation and recognition of testicular position anomalies. So investigator set up a monocentric randomized controlled trial in wich the medical students will be randomized into 2 groups : a control group receiging only book-based theoretical instruction on the examination of the external genitalia and testicular position anomalies, and a mannequin group receibing, in addition to this conventionnal instruction, simulation training on the mannequin Medical students will then attend a consultation with a child whose reason for coming to the hospital is a testicular positioning anomaly. Students clinical examination will be scored by the consulting senior, and the final diagnosis retained by the student will be compared with that retained by the consulting senior. The aim is to show that medical students who have trained on this new model are better, in terms of clinical examination and diagnostic, than students in the control group.
- Conditions
- Testicular Positioning Anomalies, Cryptorchidism
- Being tested
- testicular palpation training on a mannequin
- Keywords
- cryptorchidism, testicular palpation
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testicular palpation training on a mannequinProcedure or surgery
Study of testicular palpation training on a mannequin on the ability to perform a testicular examination and diagnose testicular positioning abnormalities
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| mannequin simulation-based learning group | Experimental | Not described Receives: Procedure: testicular palpation training on a mannequin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of correct diagnoses
The primary outcome will be the rate of correct diagnoses made by the medical students compared with the diagnosis made by the consultant surgeon.
Measured: Baseline
Secondary outcomes (1)
clinical examination score from 0 to 20
to assess the student's clinical skills and the quality of the physical examination
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular Positioning AnomaliesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Louise RENOULT, Study chair, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106502
- Sponsor's protocol ID
- 49RC24_0256
- Acronym
- PaTenSim
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning to Palpate the Child's Testicles Using Simulation
- ClinicalTrials.gov ID
- NCT07106502
- Acronym / sponsor ID
- PaTenSim / 49RC24_0256
- Conditions
- Testicular Positioning Anomalies, Cryptorchidism
- Keywords
- cryptorchidism, testicular palpation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 6 Aug 2025 (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.
Hypothesis is that better training of medical students in the examination of boy's external genitalia could improve the diagnosis of testicular position anomalies. To this end, investigators already have created a model to train testicle palpation and recognition of testicular position anomalies. So investigator set up a monocentric randomized controlled trial in wich the medical students will be randomized into 2 groups : a control group receiging only book-based theoretical instruction on the examination of the external genitalia and testicular position anomalies, and a mannequin group receibing, in addition to this conventionnal instruction, simulation training on the mannequin Medical students will then attend a consultation with a child whose reason for coming to the hospital is a testicular positioning anomaly. Students clinical examination will be scored by the consulting senior, and the final diagnosis retained by the student will be compared with that retained by the consulting senior. The aim is to show that medical students who have trained on this new model are better, in terms of clinical examination and diagnostic, than students in the control group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| mannequin simulation-based learning group | Experimental | Procedure: testicular palpation training on a mannequin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical student who volunteers to take part in the study during their pediatric or pediatric surgery clerkship or at the simulation center
Key exclusion criteria (2 listed)
- student non in pediatric intership or non in pediatric surgery intership or non at the simulation center intership
- Student with previous simulation training in the examination of the external genitalia of children
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 |
|---|---|---|
| testicular palpation training on a mannequinStudy of testicular palpation training on a mannequin on the ability to perform a testicular examination and diagnose testicular positioning abnormalities | Procedure or surgery | mannequin simulation-based learning group |
Primary outcome
Rate of correct diagnoses
Time frame: Baseline
The primary outcome will be the rate of correct diagnoses made by the medical students compared with the diagnosis made by the consultant surgeon.
1 secondary outcome
clinical examination score from 0 to 20
Time frame: Baseline
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 6 Aug 2025.
- Individual participant dataSharing planned: Undecided
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.
Louise RENOULT study chair
University Hospital of Angers
Questions about this trial
What is this clinical trial studying?
A study testing testicular palpation training on a mannequin in people with Testicular Positioning Anomalies and Cryptorchidism, run by University Hospital, Angers.
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 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: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Louise RENOULT (2 41 35 42 90 ext. +33, louise.renoult@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of correct diagnoses (time frame: Baseline). 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 6 Aug 2025.