Male CircumcisionUnicirc003NCT02091726
Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
A study testing Unicirc instrument plus cyanoacrylate tissue adhesive in people with Male Circumcision, run by Simunye Primary Health Care at 1 site in South Africa.
Trial summary
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision
- What is being tested?
- Unicirc instrument plus cyanoacrylate tissue adhesive
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2014to Sep 2014
- Phase
- Interventional
- 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 18 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men at least 18 years of age
Who cannot join
- Poor general health
- Anatomical abnormalities that would complicate circumcision
- Bleeding disorder
- Ongoing infection
- Cannot attend followup visits
Trial locations and contacts
1 site in 1 country.
About this study
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.
- Conditions
- Male Circumcision
- Being tested
- Unicirc instrument plus cyanoacrylate tissue adhesive
- Keywords
- Circumcision, HIV prevention, Surgical device, Cyanoacrylate, Tissue Adhesive, voluntary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicirc instrument plus cyanoacrylate tissue adhesiveProcedure or surgery
Also called Unicirc, Cyanoacrylate
Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
| Study group | Role | What they receive |
|---|---|---|
| Unicirc with tissue adhesive | Experimental | Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate Receives: Procedure: Unicirc instrument plus cyanoacrylate tissue adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for Procedure
Intraoperative time, total
Measured: 1 hour
Secondary outcomes (4)
Completely Healed at 4 Weeks
Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present
Measured: 4 weeks
Wound Separation
Wound separation caused by adhesive failure (minor --requires no treatment)
Measured: 4 weeks
Cosmetic Result Excellent
Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line
Measured: 4 weeks
Participant Fully Satisfied and Would Recommend to Friends and Family
Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionSep 2014
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 Male CircumcisionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simunye Primary Health Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Millard, Simunye Primary Health Care
- Investigators
- Norman Goldstuck, MD, Study director, Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091726
- Sponsor's protocol ID
- Unicirc 003
- Acronym
- Unicirc003
- Status last verified
- Sep 2018
- First submitted
- 14 Mar 2014
- Last updated
- 6 Sep 2018
- 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 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
- ClinicalTrials.gov ID
- NCT02091726
- Acronym / sponsor ID
- Unicirc003 / Unicirc 003
- Conditions
- Male Circumcision
- Keywords
- Circumcision, HIV prevention, Surgical device, Cyanoacrylate, Tissue Adhesive, voluntary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Simunye Primary Health CareUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Posted 11 Dec 2014
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 trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unicirc with tissue adhesive | Experimental | Procedure: Unicirc instrument plus cyanoacrylate tissue adhesiveCircumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men at least 18 years of age
Key exclusion criteria (5 listed)
- Poor general health
- Anatomical abnormalities that would complicate circumcision
- Bleeding disorder
- Ongoing infection
- Cannot attend followup visits
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 instrument plus cyanoacrylate tissue adhesiveAlso: Unicirc, CyanoacrylateVolunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive | Procedure or surgery | Unicirc with tissue adhesive |
Primary outcome
Time for Procedure
Time frame: 1 hour
Intraoperative time, total
4 secondary outcomes
Completely Healed at 4 Weeks
Time frame: 4 weeks
Wound Separation
Time frame: 4 weeks
Cosmetic Result Excellent
Time frame: 4 weeks
Participant Fully Satisfied and Would Recommend to Friends and Family
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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, MD study director
Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unicirc instrument plus cyanoacrylate tissue adhesive in people with Male Circumcision, 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 6 Sep 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2014). 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?
Time for Procedure (time frame: 1 hour). 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 NCT02091726, 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 6 Sep 2018.