An interventional study of Male circumcision using the Shang Ring device in Human Immunodeficiency Virus, sponsored by EngenderHealth. Completed at 1 site in Kenya. Open to male participants aged 1 Month to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-19.
Sponsored by EngenderHealth · Not applicable, Interventional, and Prevention
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 80 is below the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →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 →
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.
Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm study study for use of Shang Ring device for male circumcision in children
Device: Male circumcision using the Shang Ring device
Also known as: Shang ring male circumcision device
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
Time frame: 42 days after circumcision
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.
Time frame: 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.
Evaluation of the course of healing and length of time required for complete healing will be based on clinical exam findings.
Time frame: 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.
Time frame: 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
Time frame: 42 days after circumcision
The record gives a start of Jul 2013, a primary completion of Nov 2013 and a completion of Nov 2013. 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.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome →
EngenderHealth