Circumcision, MalePhase 4NCT02593630
Unicirc Adolescent 12-15 Year Old Boys
A Phase 4 study testing Unicirc circumcision in people with Circumcision, Male, run by Simunye Primary Health Care at 1 site in South Africa.
Trial summary
This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years. Read more about this study
- Who is it for?
- Ages 12 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- Unicirc circumcision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2016to 15 Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 15 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy boys desiring circumcision
Who cannot join
- current illness
- bleeding disorder
- reaction to local anaesthetic
- infection
- any penile abnormality potentially complicating circumcision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Field Study of Unicirc Circumcision in Adolescent Boys, Aged 12 to 15 Years.
This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.
Read the detailed description
Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.
- Conditions
- Circumcision, Male
- Being tested
- Unicirc circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicirc circumcisionDevice
Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
| Study group | Role | What they receive |
|---|---|---|
| Unicirc circumcision | Experimental | Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive Receives: Device: Unicirc circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Duration
Duration from placement of instrument to dressing
Measured: Intraoperative, 10-15 minutes
Secondary outcomes (2)
Intraoperative Pain
Intraoperative pain, measured on a standard 10 point pain scale (0=no pain, 5=moderate pain, 10 severe pain) using a pain face diagram.
Measured: Time of surgery, approximately 10-15 minutes
Healed at 4 Weeks
Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks.
Measured: At the 4-week followup visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startApr 2016
- Primary completion15 Nov 2016
- Study completion15 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circumcision, MaleStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simunye Primary Health Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Millard, University of New England
- Investigators
- Norman Goldstuck, Study director, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593630
- Sponsor's protocol ID
- Unicirc Adolescent
- Status last verified
- Jan 2019
- First submitted
- 29 Oct 2015
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.
PubMed 25822727
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Study of Unicirc Circumcision in Adolescent Boys, Aged 12 to 15 Years.
- ClinicalTrials.gov ID
- NCT02593630
- Acronym / sponsor ID
- Unicirc Adolescent
- Conditions
- Circumcision, Male
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Simunye Primary Health CareUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.
Detailed description
Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unicirc circumcision | Experimental | Device: Unicirc circumcisionUnicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy boys desiring circumcision
Key exclusion criteria (5 listed)
- current illness
- bleeding disorder
- reaction to local anaesthetic
- infection
- any penile abnormality potentially complicating circumcision
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 |
|---|---|---|
| Unicirc circumcisionUnicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive | Device | Unicirc circumcision |
Primary outcome
Intraoperative Duration
Time frame: Intraoperative, 10-15 minutes
Duration from placement of instrument to dressing
2 secondary outcomes
Intraoperative Pain
Time frame: Time of surgery, approximately 10-15 minutes
Healed at 4 Weeks
Time frame: At the 4-week followup visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25822727Millard PS, Goldstuck ND. No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial. PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.
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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.
Norman Goldstuck study director
University of Stellenbosch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unicirc circumcision in people with Circumcision, Male, run by Simunye Primary Health Care at 1 site in South Africa.
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 5 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 4 Feb 2019. 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 South Africa. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraoperative Duration (time frame: Intraoperative, 10-15 minutes). 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 NCT02593630, which also lists 1 linked publication.
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 4 Feb 2019.