Male CircumcisionNCT01247844
Evaluation of Healing at Three Time Intervals and Potential for Spontaneous Detachment
A study testing Shang Ring in people with Male Circumcision, run by FHI 360 at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision
- What is being tested?
- Shang Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be aged 18 and 54 years;
- Must be uncircumcised (on examination);
- Must be in good general health;
- Must be HIV sero-negative, with documentation of testing no mor than one week before the procedure;
- Must be free of genital ulcerations or other visible signs of sexually transmissible infections(STI) on examination;
- Must be able to understand study procedures and requirements of study participation;
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- Must agree to return to the healthcare facility for the full schedule of follow-up visits after his circumcision;
- Must freely consent to participate in the study and sign a written informed consent form;
- Must have a cell phone or access to a cell phone; and,
- Must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.
Who cannot join
- 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 an active genital infection, anatomic abnormality or other condition, which in the opinion of the surgeon, prevents the man from undergoing a circumcision;
- Has known bleeding/clotting disorder (e.g. hemophilia); and,
- Has thalassemia (an inherited autosomal recessive blood disease).
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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.
- Conditions
- Male Circumcision
- Being tested
- Shang Ring
- Keywords
- adult Males, circumcision, HIV prevention, device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shang RingDevice
The Shang Ring is a sterile device consisting of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. The man must return to the clinic for device removal. To remove the device, the outer ring locking mechanism is broken open using a tool that is similar to a scalpel handle. Then, a pair of special scissors, specifically designed for this purpose, is used to remove the inner ring after healing
| Study group | Role | What they receive |
|---|---|---|
| Day 7 | Other | removal of Shang Ring at 7 days Receives: Device: Shang Ring |
| Day 14 | Other | removal of Shang Ring at 14 days Receives: Device: Shang Ring |
| Day 21 | Other | removal of Shang Ring at 21 days Receives: Device: Shang Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asses healing time
Assess healing time from date of circumcision
Measured: six weeks
spontaneous detachment of device
Spontaneous detachment from date of circumcision to three weeks post procedure
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male CircumcisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya National AIDS & STI Control Programme, Ministry of Medical Services, Kenya, EngenderHealth, Cornell University
- Responsible party
- Sponsor
- Investigators
- Marc Goldstein, M.D., Study chair, Weill Cornell Medical College, NY, USAMark Barone, DVM; MS, Study chair, EngenderHealth, NY, USAPhilip S. Li, MD, Principal investigator, Weill Medical College of Cornell UniversityPuneet Masson, MD, Principal investigator, Weill Medical College of Cornell UniversityPaul Perchal, MA, Principal investigator, EngenderHealthJared Moguche, MB ChB, Principal investigator, EngenderHealthQuentin Awori, MB ChB, Principal investigator, Engender HealthPeter Cherutich, MB ChB MPH, Principal investigator, National AIDS/STD Control Programme, Nairobi, Kenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247844
- Sponsor's protocol ID
- 10214
- Status last verified
- Mar 2015
- First submitted
- 7 Sep 2010
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Healing at Three Time Intervals and Potential for Spontaneous Detachment
- ClinicalTrials.gov ID
- NCT01247844
- Acronym / sponsor ID
- 10214
- Conditions
- Male Circumcision
- Keywords
- adult Males, circumcision, HIV prevention, device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Kenya National AIDS & STI Control Programme, Ministry of Medical Services, Kenya, EngenderHealth, Cornell University
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Day 7 | Other | Device: Shang Ringremoval of Shang Ring at 7 days |
| Day 14 | Other | Device: Shang Ringremoval of Shang Ring at 14 days |
| Day 21 | Other | Device: Shang Ringremoval of Shang Ring at 21 days |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Must be aged 18 and 54 years;
- Must be uncircumcised (on examination);
- Must be in good general health;
- Must be HIV sero-negative, with documentation of testing no mor than one week before the procedure;
- Must be free of genital ulcerations or other visible signs of sexually transmissible infections(STI) on examination;
Key exclusion criteria (5 listed)
- 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 an active genital infection, anatomic abnormality or other condition, which in the opinion of the surgeon, prevents the man from undergoing a circumcision;
- Has known bleeding/clotting disorder (e.g. hemophilia); and,
- Has thalassemia (an inherited autosomal recessive blood disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shang RingThe Shang Ring is a sterile device consisting of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. The man must return to the clinic for device removal. To remove the device, the outer ring locking mechanism is broken open using a tool that is similar to a scalpel handle. Then, a pair of special scissors, specifically designed for this purpose, is used to remove the inner ring after healing | Device | Day 14, Day 21, Day 7 |
Primary outcome
Asses healing time
Time frame: six weeks
Assess healing time from date of circumcision
spontaneous detachment of device
Time frame: 21 days
Spontaneous detachment from date of circumcision to three weeks post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Goldstein, M.D. study chair
Weill Cornell Medical College, NY, USA
Mark Barone, DVM; MS study chair
EngenderHealth, NY, USA
Philip S. Li, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shang Ring in people with Male Circumcision, run by FHI 360 at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asses healing time (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.