Status:
WITHDRAWN
Evaluation and Adverse Event Surveillance for Initial Implementation of ShangRing Circumcision in Mozambique
Lead Sponsor:
Jhpiego
Collaborating Sponsors:
Ministry of Health, Mozambique
Centers for Disease Control and Prevention
Conditions:
Circumcision, Male
Eligibility:
MALE
13+ years
Phase:
NA
Brief Summary
This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and ...
Detailed Description
This is a single-arm interventional study of 1000 male circumcision procedures using the ShangRing device. The primary objective of the study is to enhance understanding of the potential clinical and ...
Eligibility Criteria
Inclusion
- Male, 13 years old and above
- Agrees to return to the facility where circumcision procedure is done for device removal on day 7 and to have home or off-site visits if deemed necessary by the ShangRing™ providers
- Is able and willing to provide a valid physical address of residence and at least one alternate address (address of employer, school, or friend/relative) for tracing
- Is able and willing to provide a valid primary phone number and at least one alternate phone number (phone number of friend/relative) and agrees to be contacted via that alternate number and person. This will facilitate telephone-based follow-up should he not return for the scheduled post-removal follow-up visits.
Exclusion
- Males below 13 years of age
- Males for whom the correct fitting size of ShangRing™ Device is not available
- Anatomical abnormalities including adhesions
- Cognitive impairment
- Any health condition (reported or observed) that ShangRing™ providers deem a contraindication to the procedure. These may include history of diabetes, peripheral vascular disease, cancer, bleeding disorders, and/or current moderate or severe infectious illness
- HIV - positive (although may still undergo surgical circumcision)
- Anatomical variations and anomalies of genitalia
- Hypospadias, epispadias, or other urethral anomaly
- Hydrocele
- Scrotal hernia
- Other genital anomaly or disease including infectious or traumatic ulcers
- Dermatitis of the penis or foreskin
- Genital warts
- Urethral discharge
- Balanitis
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03761836
Start Date
November 1 2020
End Date
December 30 2021
Last Update
December 22 2020
Active Locations (3)
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1
Matola II Health Center
Matola, Maputo Province, Mozambique
2
September 17 Health Center
Quelimane, Zambezia Province, Mozambique
3
Infulene Psychiatric Hospital
Maputo, Mozambique