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Unicirc Adolescent 12-15 Year Old Boys

S

Simunye Primary Health Care

Status and phase

Completed
Phase 4

Conditions

Circumcision, Male

Treatments

Device: Unicirc circumcision

Study type

Interventional

Funder types

Other

Identifiers

NCT02593630
Unicirc Adolescent

Details and patient eligibility

About

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

Full description

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

Enrollment

54 patients

Sex

Male

Ages

12 to 15 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy boys desiring circumcision

Exclusion criteria

  • current illness
  • bleeding disorder
  • reaction to local anaesthetic
  • infection
  • any penile abnormality potentially complicating circumcision

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

54 participants in 1 patient group

Unicirc circumcision
Experimental group
Description:
Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive
Treatment:
Device: Unicirc circumcision

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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