Undescended TestisNCT02731989
Comparison Between the Clinical Assessment of the Undescended Testis and Its' Ultrasonographic Size
An observational study of Undescended Testis, run by Meir Medical Center at 1 site in Israel.
Trial summary
In addition to the manual preoperative examination, the undescended testicle will be measured ultrasonographically. The compared data will help us to evaluate the routine need for preoperative ultrasonographic evaluation of the undescended testicle. Read more about this study
- Who is it for?
- Ages 1 year to 13 years, men only
- Conditions the study is for
- Undescended Testis
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Jul 2017to 24 Jul 2019
- 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 1 year to 13 years
- Men only
- No healthy volunteers
- Child
Study population: Boys operated for unilateral cryptorchism
Who may be able to join
- Boys operated for unilateral cryptorchism
Who cannot join
- bilateral cryptorchism recurrent operation s/p inguinal operation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Centre
Kfar Saba, 44281
Zvi Steiner, MD, 050-6246788, zvi.steiner@clalit.org.il
About this study
In addition to the manual preoperative examination, the undescended testicle will be measured ultrasonographically. The compared data will help us to evaluate the routine need for preoperative ultrasonographic evaluation of the undescended testicle.
- Conditions
- Undescended Testis
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | The surgeon will estimate the size difference between the undescended and the normally located testis. Independently the ultrasonographer will measure the true size of both testes in the study group. | |
| Control group | The same measurments will be done by the surgeon and the ultrasonographer on boys without cryptorchism. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the testicular size estimated by the surgeon and the actual ultrasonographic size
The difference between the testicular size estimated by the surgeon and the actual ultrasonographic size
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start24 Jul 2017 (estimated)
- Primary completion24 Jul 2018 (estimated)
- Study completion24 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undescended TestisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731989
- Sponsor's protocol ID
- 0090-16-MMC
- Status last verified
- Jul 2017
- First submitted
- 4 Apr 2016
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Clinical Assessment of the Undescended Testis and Its' Ultrasonographic Size
- ClinicalTrials.gov ID
- NCT02731989
- Acronym / sponsor ID
- 0090-16-MMC
- Conditions
- Undescended Testis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 24 Jul 2017 (estimated)
- Primary completion
- 24 Jul 2018 (estimated)
- Study completion
- 24 Jul 2019 (estimated)
- First posted
- 8 Apr 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.
In addition to the manual preoperative examination, the undescended testicle will be measured ultrasonographically. The compared data will help us to evaluate the routine need for preoperative ultrasonographic evaluation of the undescended testicle.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –The surgeon will estimate the size difference between the undescended and the normally located testis. Independently the ultrasonographer will measure the true size of both testes in the study group. |
| Control group | – | –The same measurments will be done by the surgeon and the ultrasonographer on boys without cryptorchism. |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Boys operated for unilateral cryptorchism
Key inclusion criteria (1 listed)
- Boys operated for unilateral cryptorchism
Key exclusion criteria (1 listed)
- bilateral cryptorchism recurrent operation s/p inguinal operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference between the testicular size estimated by the surgeon and the actual ultrasonographic size
Time frame: 3 years
The difference between the testicular size estimated by the surgeon and the actual ultrasonographic size
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
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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.
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 Undescended Testis, run by Meir Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 13 Jul 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zvi Steiner, MD (050-6246788, zvi.steiner@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the testicular size estimated by the surgeon and the actual ultrasonographic size (time frame: 3 years). 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 13 Jul 2017.