CompletedNCT02390310Updated Aug 3, 2016

Simplifying the Shang Ring Technique for Circumcision of Men and Boys

An interventional study of Shang Ring and injectable anesthesia (lidocaine 1%) in Human Immunodeficiency Virus, sponsored by EngenderHealth. Completed at 2 sites in Kenya. Open to male participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-03.

Primary conditionAcquired Immunodeficiency Syndrome(the registry's first term)UnverifiedIs this wrong?The registry often attaches Acquired Immunodeficiency Syndrome to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by EngenderHealth · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 574
Allocation: Randomized
Ages: 10 Years and older
Sex: Male

Study summary

This is a research study in Kenya that will examine the outcomes of participants aged 10-15 and 16 and older; and provider acceptability of the Shang Ring technique for male circumcision that would simplify use. The study will be in two phases:

Phase 1 will explore the no-flip technique that has been used in China but will be used for the first time in Africa.

Phase 2 will be a randomized trial comparing use of tropical vs. injectable anesthesia.

Read the detailed description

The study, to be conducted in two phases, will examine procedural and clinical outcomes, as well as participant and provider acceptability, of adaptations of the Shang Ring technique for male circumcision that would simplify its use and increase its acceptability.

Phase I will be non-comparative for exploration of the no-flip technique for Shang Ring circumcision (i.e. all participants will be circumcised using the no-flip Shang Ring technique). Historical data from standard Shang Ring circumcisions conducted in Africa (Kenya, Uganda and Zambia) will be used as the comparison group. Men will be randomized to removal at 7 days after circumcision vs. delayed removal, to assess occurrence and safety of spontaneous detachments following circumcision with the no-flip technique.
Phase 2 will compare the use of topical vs. injectable anesthesia for Shang Ring circumcision. Participants will be randomized to topical vs. injectable anesthesia in a 2:1 ratio. The investigators rationalize the 2:1 randomization scheme given that the investigators will have just completed Phase I in which 200 men and boys will have been circumcised using the no-flip technique with injected anesthesia. However, given the subjectivity associated with using reported pain as the primary endpoint, the investigators believe it is critical to randomize participants in this phase of the study.

Conditions studied

Human Immunodeficiency Virus

Browse trials for

Acquired Immunodeficiency Syndrome 3,035Registry's first term · unverified

Keywords

male circumcision
Shang Ring
male circumcision device
prevention
voluntary medical male circumcision (VMMC)

In context

Acquired Immunodeficiency Syndrome Unverified

3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.

This study's enrollment of 574 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

EngenderHealth is the lead sponsor of 4 studies on the registry; none are open to participants now.

Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

Who can participate

Ages eligible: 10 Years and older
Sexes eligible: Male
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Aged 10 years and older;
Uncircumcised upon clinical examination;
In good general health;
Free of genital ulcerations or other visible signs of sexually transmitted infections upon clinical examination;
Participant and parent or legally acceptable representative (LAR) as applicable must be able to understand study procedures and requirements of study participation;
Freely consents to participate in the study and signs a written form if 18 years of age or greater
Accompanied by the parent/LAR, who freely consents and signs an informed consent form for participation of the child into the study for participants less than 18 years old;
Assent from participant less than 18 years old who understand study procedure;
Participant must agree to return to the study site for the full schedule of follow-up visits after his circumcision (or as appropriate the Parent or LAR must agree to bring the participant);
Participant and parent/LAR as appropriate must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.

Exclusion criteria

Exclusion Criteria:

Has a known allergy or sensitivity to lidocaine or other local anesthesia;
Takes a medication that would be a for elective surgery, such as an anticoagulant or ;
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. 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 574 participants (actual)

Study arms

Active comparator
Phase 1 - 7 Day Removal
Shang Ring No Flip Technique: Removal of Shang Ring and assessment of healing 7 days after circumcision with no-flip technique.
Device: Shang Ring
Active comparator
Phase 1 - Delayed Removal
Shang Ring No Flip Technique: Removal of ring or assessment of spontaneous detachment at more than 7 days to assess occurrence and safety following circumcision with the no-flip technique.
Device: Shang Ring
Active comparator
Phase 2 - Topical Anesthesia
Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery using topical anesthesia.
Drug: topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)
Active comparator
Phase 2 - Injectable Anesthesia
Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery when using injectable anesthesia.
Drug: injectable anesthesia (lidocaine 1%)

Interventions

DeviceShang Ring
Comparison of healing times at 7 day and more than 7 days after circumcision.
Also known as: Shang Ring No Flip Technique
Druginjectable anesthesia (lidocaine 1%)
Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.
Drugtopical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)
Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.

What researchers measure

Primary outcomes

Phase I: Combined rate of moderate and severe adverse events (AEs) as a measure of safety of the no-flip technique for Shang Ring circumcision in males aged 10 years and older
We will evaluate the rate of moderate and severe AEs (combined) following Shang Ring MC using the no-flip technique based on clinical exam findings.
Time frame: 42 days
Phase 2: Pain measured with the visual analogue scale (VAS) experienced during the Shang Ring circumcision procedure with topical (EMLA Cream; lidocaine 2.5% and prilocaine 2.5%) vs. injectable (1% lidocaine) anesthesia.
The outcome metric for the primary outcome will be maximum pain reported to have been experienced by participants during the Shang Ring circumcision, assessed using the visual analogue scale (VAS), reported immediately after completion of the Shang Ring circumcision procedure
Time frame: 42 days

Secondary outcomes

Phase I: Ease of use of the Shang Ring with the no-flip technique as measured by MC procedure and device removal times and problems encountered during MC and removal procedures
To evaluate ease of use with the no-flip technique we will document MC procedure and device removal times and problems encountered during MC and removal procedures
Time frame: 42 days
Phase I: Satisfaction of the no-flip Shang Ring among study participants
we will interview participants/parents/guardians to document acceptability and satisfaction with the Shang Ring circumcision, procedure and post-procedure pain, and time to return to normal activity
Time frame: 42 days
Phase I: Occurrence of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision
we will gather data on timing of spontaneous detachment among those participants wearing the Shang Ring for more than 7 days days after circumcision
Time frame: 42 days
Phase I: Safety of spontaneous detachment as measured by AEs among those participants wearing the Shang Ring for more than 7 days after circumcision
we will gather data to document AEs among those participants wearing the Shang Ring for more than 7 days after circumcision
Time frame: 42 days
Phase 2: Safety of topical vs. injectable anesthesia for local anesthesia during Shang Ring circumcision as measured by rates of moderate and severe AEs (combined rates)
we will document rates of moderate and severe AEs among those having a Shang Ring circumcision with topical vs. injectable anesthesia
Time frame: 42 days
Phase 2: Satisfaction with topical vs. injectable anesthetic among study participants
we will interview study participants and their parents/guardians appropriate to document acceptability and satisfaction with the circumcision, the Shang Ring procedure, post-procedure pain, and time to return to normal activity between the two techniques
Time frame: 42 days

Study locations

2 sites

Homa Bay Level IV County Hospital
Homa Bay, Homa Bay County, Kenya
Vipingo Health Center
Vipingo, Kilifi County, Kenya

References and documents

Publications

Al Hussein Alawamlh O, Awori QD, Barone MA, Kim SJ, Goldstein M, Li PS, Lee RK. No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya. PLoS One. 2020 May 22;15(5):e0233150. doi: 10.1371/journal.pone.0233150. eCollection 2020. PubMed 32442198 ↗
Awori Q, Li PS, Lee RK, Ouma D, Oundo M, Barasa M, Obura N, Mwamkita D, Simba R, Oketch J, Nyangweso N, Maina M, Kiswi N, Kirui M, Chirchir B, Goldstein M, Barone MA. Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial. PLoS One. 2019 Aug 14;14(8):e0218066. doi: 10.1371/journal.pone.0218066. eCollection 2019. PubMed 31412032 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2015, a primary completion of Jul 2016 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 5, 2015
First posted: Mar 17, 2015
Start: May 2015
Primary completionActual: Jul 2016
CompletionActual: Jul 2016
Last update: Aug 3, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02390310
Lead sponsor: EngenderHealth
Collaborators: Weill Medical College of Cornell University, Bon Sante Consulting Limited, Kenya National AIDS & STI Control Programme, Kenya Ministry of Health
Responsible party: Sponsor
First posted: Mar 17, 2015
Start date: May 2015
Primary completion: Jul 2016
Completion: Jul 2016
Last update: Aug 3, 2016

Study contacts

Mark A Barone, DVM, MS

principal investigator · EngenderHealth

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Lidocaine

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