Male Circumcision Clinical Trial
Official title:
Evaluation of Healing at Three Time Intervals and Potential for Spontaneous Detachment
The objective of this research study is to evaluate the safety and acceptability of the
Shang Ring method of medical male circumcision. The Shang Ring is a new circumcision device
with a potential role in the safe and cost-effective delivery of circumcision services. The
device, developed in China, consists of two concentric plastic rings. Following a ring
penile block, the smaller ring is fitted at the base of the coronal sulcus. The foreskin is
everted over the inner ring and the larger outer ring is secured over the inner ring. The
foreskin is excised and several nicks are made on the incision line to prevent formation of
a constricting, circumferential scab. No suturing is required.
In this study, the investigators will evaluate wound healing of men randomized to removal of
the Shang Ring at one of three different points in time (Days 7, 14 or 21). Leaving the
device on for 14 or 21 days constitutes extended wear of the device.
Sites: Homa Bay District Hospital, Nyanza Province, Kenya
The objective of this research study is to evaluate the safety and acceptability of the
Shang Ring method of medical male circumcision. The Shang Ring is a new circumcision device
with a potential role in the safe and cost-effective delivery of circumcision services. The
device, developed in China, consists of two concentric plastic rings. Following a ring
penile block, the smaller ring is fitted at the base of the coronal sulcus. The foreskin is
everted over the inner ring and the larger outer ring is secured over the inner ring. The
foreskin is excised and several nicks are made on the incision line to prevent formation of
a constricting, circumferential scab. No suturing is required.
In this study, we will evaluate wound healing of men randomized to removal of the Shang Ring
at one of three different points in time (Days 7, 14 or 21). Leaving the device on for 14 or
21 days constitutes extended wear of the device.
Although male circumcision has a demonstrated protective effect against HIV transmission,
currently available surgical techniques and devices have limitations for widespread
deployment in resource-poor areas. High costs and scarcity of trained providers hinder
access to male circumcision services in resource-poor areas. Its simple design sets the
Shang Ring apart from other male circumcision techniques. The Shang Ring has the potential
for safe, effective and inexpensive delivery of male circumcision by trained healthcare
personnel in HIV endemic countries.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02242565 -
Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia
|
N/A | |
| Completed |
NCT00993811 -
The Shang Ring: A Novel Male Circumcision Device for HIV Prevention
|
Phase 1 | |
| Completed |
NCT02281435 -
Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure Subjects
|
N/A | |
| Completed |
NCT04263064 -
High Volume Caudal Study
|
Early Phase 1 | |
| Completed |
NCT02091726 -
Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
|
N/A | |
| Completed |
NCT02309710 -
Male Circumcision (MC) Using the ShangRing™ Device in Malawi
|
Phase 1 | |
| Completed |
NCT02167776 -
From Obstacles to Opportunities for Male Circumcision in Tanzania
|
N/A | |
| Completed |
NCT01150370 -
A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings
|
N/A | |
| Completed |
NCT01434628 -
Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Non-Surgical Circumcision When Performed by Nurses
|
N/A | |
| Active, not recruiting |
NCT03914365 -
Pudendal Nerve Block vs Penile Nerve Block for Analgesia During Pediatric Circumcision
|
N/A | |
| Completed |
NCT01921608 -
Safety Study of the PrePex Device for Non-Surgical Adult Male Circumcision During Phased in National Implementation in an Effort to Prevent the Spread of HIV
|
N/A | |
| Completed |
NCT03634358 -
Bipolar Scissors for Circumcision
|
N/A | |
| Completed |
NCT02277795 -
Evaluation of the AccuCirc for Early Infant Male Circumcision in Nyanza, Kenya
|
N/A | |
| Completed |
NCT01567436 -
A Prospective Field Study: Introducing the Shang Ring in Routine Clinical Settings
|
Phase 4 | |
| Completed |
NCT03223532 -
Randomized Trial Comparing PrePex Day 7 Foreskin Removal Procedure (FRP) to a Day 0 PrePex FRP .
|
N/A |