Unicirc Adolescent 12-15 Year Old Boys

NCT ID: NCT02593630

Last Updated: 2019-02-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-11-15

Brief Summary

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This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.

Detailed Description

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Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.

Conditions

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Circumcision, Male

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Unicirc circumcision

Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive

Group Type EXPERIMENTAL

Unicirc circumcision

Intervention Type DEVICE

Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive

Interventions

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Unicirc circumcision

Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* healthy boys desiring circumcision

Exclusion Criteria

* current illness
* bleeding disorder
* reaction to local anaesthetic
* infection
* any penile abnormality potentially complicating circumcision
Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Simunye Primary Health Care

OTHER

Sponsor Role lead

Responsible Party

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Peter Millard

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norman Goldstuck

Role: STUDY_DIRECTOR

University of Stellenbosch

Locations

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Simunye Primary Healthcare

Cape Town, Western Cape, South Africa

Site Status

Countries

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South Africa

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.

Reference Type BACKGROUND
PMID: 25822727 (View on PubMed)

Other Identifiers

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Unicirc Adolescent

Identifier Type: -

Identifier Source: org_study_id

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