Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
NCT ID: NCT02091726
Last Updated: 2018-09-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2014-03-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Unicirc with tissue adhesive
Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Unicirc instrument plus cyanoacrylate tissue adhesive
Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Interventions
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Unicirc instrument plus cyanoacrylate tissue adhesive
Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Anatomical abnormalities that would complicate circumcision
* Bleeding disorder
* Ongoing infection
* Cannot attend followup visits
18 Years
99 Years
MALE
Yes
Sponsors
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Simunye Primary Health Care
OTHER
Responsible Party
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Peter Millard
PI
Principal Investigators
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Norman Goldstuck, MD
Role: STUDY_DIRECTOR
Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa
Locations
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Simunye Primary Healthcare
Cape Town, Western Cape, South Africa
Countries
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References
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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.
Other Identifiers
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Unicirc 003
Identifier Type: -
Identifier Source: org_study_id
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