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| ID | Type | Description | Link |
|---|---|---|---|
| GCC-0139 | Other Grant/Funding Number | Grand Challenges Canada |
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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
| Kenya National AIDS & STI Control Programme | OTHER |
| Kenya Ministry of Health | OTHER_GOV |
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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.
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 efficacy, procedure time, difficulties during surgery and post-operative events shall be assessed. To evaluate safety, the investigators will clinically observe for adverse events during the course of healing. The investigators will also evaluate to length of time taken for complete healing to be achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | Single arm study study for use of Shang Ring device for male circumcision in children |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Male circumcision using the Shang Ring device | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents. | To evaluate efficacy, procedure time, peri- and postoperative surgical complications, and problems with use of the device will be assessed. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quentin Awori, MBChB, CPI | EngenderHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Homa Bay District Hospital | Homa Bay | Kenya |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Evaluation of the course of healing and length of time required for complete healing will be based on clinical exam findings. |
| 42 days after circumcision |
| To determine the acceptability of the Shang Ring device by the participants (or their parents) | Clients and/or parents shall be interviewed on their experience with the Shang Ring during their participation in the study. | 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 | To evaluate the ease of use of the Shang Ring device, clinicians shall be interviewed on the difficulties they faced with using the device and their perception about use of the device relative to conventional surgical approaches | 42 days after circumcision |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |