NCT01891409

Brief Summary

A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and course of wound healing when using the Shang Ring technique across the four childhood age groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

June 25, 2013

Last Update Submit

January 15, 2015

Conditions

Human Immunodeficiency Virus

Keywords

HIV preventionMale CircumcisionChildrenChildhoodShang Ring

Outcome Measures

Primary Outcomes (1)

  • To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.

    Documentation of adverse events based on clinical exam findings

    42 days after circumcision

Secondary Outcomes (4)

  • To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.

    42 days after circumcision

  • To evaluate the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.

    42 days after circumcision

  • To determine the acceptability of the Shang Ring device by the participants (or their parents)

    42 days after circumcison

  • To evaluate the ease of use of the Shang Ring technique across the 4 age groups ranging from infants to adolescents

    42 days after circumcision

Study Arms (1)

Single arm

OTHER

Single arm study study for use of Shang Ring device for male circumcision in children

Device: Male circumcision using the Shang Ring device

Interventions

Male circumcision using the Shang Ring deviceDEVICE
Also known as: Shang ring male circumcision device
Single arm

Eligibility Criteria

Age1 Month - 17 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Must be accompanied by the parent or legally acceptable representative (LAR), who freely consents for participation of the child into the study;
  • Assent from participant 7 years of age and above who understand study procedure;
  • Aged between 1 month and 17 years(inclusive);
  • Body weight of more than 2.5 kgs and penile shaft more than 1 cm in length.
  • Must be in good general health;
  • Must be free of genital ulcerations or other visible signs of STI (on examination);
  • Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;
  • Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
  • Parent or LAR must have a cell phone or access to a cell phone; and,
  • Parent or LAR must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.

You may not qualify if:

  • Has a known allergy or sensitivity to lidocaine or other local anesthesia;
  • Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
  • Has known bleeding/clotting disorder (e.g. hemophilia);
  • Has any congenital genitourinary abnormality;
  • Has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or
  • Is currently participating in another biomedical research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Homa Bay District Hospital

Homa Bay, Kenya

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Quentin Awori, MBChB, CPI

    EngenderHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2013

First Posted

July 3, 2013

Study Start

July 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

KE(1)