Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision (EIMC) in Sub-Saharan Africa
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|ClinicalTrials.gov Identifier: NCT03338699|
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : February 21, 2020
The study will evaluate the safety and acceptability of the topical anesthesia-based, no-flip ShangRing technique vs. Mogen clamp for Early Infant Male Circumcision (EIMC) in neonates and infants up to 60 days of life.
The study will consist of 2 phases; a pilot phase and a field study. In the pilot phase, male infants of up to 60 days of life will be enrolled in three sub-Saharan countries, specifically Kenya, Tanzania, and Uganda. Infants will be randomized in 1:1 fashion to undergo EIMC using either the Mogen clamp or no-flip ShangRing technique using topical anesthesia. Upon completion of the pilot trial and assuming satisfactory safety results, a larger non-comparative field study of ShangRing EIMC will be initiated, as performed by non-physician providers in routine practice settings in the three sub-Saharan African countries.
Total study duration will be 3 years. The pilot phase is anticipated to encompass a total of 1 year. Completion of the field study is expected to take 2 years.
Study Endpoints include:
- To compare the rates of adverse events (AEs) with the ShangRing or Mogen clamp
- To compare pain control, time to complete wound healing and parent satisfaction with EIMC using the ShangRing or Mogen clamp
- To compare operative time and provider preference.
- To assess the rate of spontaneous ring detachment with the ShangRing as a method to decrease the need for follow-up visits after circumcision.
- To assess the subpreputial microbiome of the infants prior to and after the initiation of circumcision
Three correlative studies will be conducted:
- Penile microbiome study: In the pilot trial, the subpreputial microbiome of the infants undergoing circumcision will be assessed to better understand the spectrum of bacteria that may exist and play a role in infant circumcision.
- Demand creation study: During both the pilot phase and the field study, it will be assessed whether device-driven EIMC can be safely and effectively integrated into maternal and child health services as a method to promote demand creation.
- Cost impact study: During both the pilot phase and the field study, a comparative cost analysis of EIMC with ShangRing versus Mogen clamp will be performed, in addition to a cost analysis of ShangRing EIMC as performed in routine clinical settings in the field study. The costing of demand creation will also be assessed.
|Condition or disease||Intervention/treatment||Phase|
|Circumcision||Device: ShangRing Device: Mogen clamp||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1380 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||In the pilot phase of the study, participating infants will be allocated to circumcision with either the ShangRing or Mogen clamp. Infants will be randomized in a 1:1 fashion.|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision (EIMC) in Sub-Saharan Africa|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
Topical anesthesia based, no-flip ShangRing circumcision.
Topical anesthesia based, no-flip ShangRing circumcision.
Active Comparator: Mogen clamp
Mogen clamp circumcision.
Device: Mogen clamp
Mogen clamp circumcision
- Number and severity of adverse events in participants undergoing circumcision with either device based on WHO/JHPIEGO definitions and guidelines. [ Time Frame: Up to 8 weeks post-circumcision. ]Adverse events will be pre-specified based on WHO/JHPIEGO definitions of the nature and severity of adverse events, and classified as related or unrelated to EIMC. Adverse events will also include device-related malfunctions and displacements.
- Pain scores associated with the circumcision procedure by either device, assessed using the Neonatal Infant Pain Scale (NIPS). [ Time Frame: At the time of circumcision procedure. ]Pain scores will be recorded at the time of circumcision procedure using NIPS. NIPS is based on facial expression, crying, breathing patterns, movement of arms and legs, and state of arousal of the infant. A score of 0 is classified as no pain while a score of 6 is most severe.
- Time to complete wound healing based on having an intact clean scar with no dehiscence. [ Time Frame: Till complete wound healing is reported, up to 8 weeks post-circumcision. ]Circumcision wound is examined at each follow-up visit to check for complete healing. Additional follow-up visits may be needed if complete healing was not reported at the end of scheduled visits.
- Parent satisfaction based on post-circumcision interviews. [ Time Frame: Up to 8 weeks post-circumcision. ]Parents will be interviewed after their infant had undergone circumcision to express their views on the procedure. They will be required to note whether they are satisfied or dissatisfied about different aspects relating to the procedure and the study.
- Operative time measured in minutes. [ Time Frame: At the time of circumcision on procedure day. ]Providers will record, in minutes, the amount of time required to complete the circumcision procedure with the ShangRing and Mogen clamp. Recorded time will not include duration of anesthesia administration, or duration for the anesthetic to take effect.
- Provider preference of circumcision device based on post-circumcision interviews. [ Time Frame: Up to 8 weeks post-circumcision. ]Health providers who will perform the circumcision procedures using the ShangRing and Mogen clamp will be interviewed to express their views and degree of satisfaction with the devices.
- Spontaneous detachment as a measure to decrease the need of follow-up visits based on the amount of time, in days, it takes for the device to fall off on its own. [ Time Frame: Up to 4 weeks post-circumcision. ]Parents/LARs of infants who underwent ShangRing circumcision will be asked about the date of device detachment if the device is no longer attached at the time of visit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338699
|Contact: Richard K Lee, MD, MBA||+1 firstname.lastname@example.org|
|Contact: Philip S Li, MDemail@example.com|
|Homa Bay County Teaching and Referral Hospital||Recruiting|
|Homa Bay, Kenya|
|Contact: Quentin Awori, MD MPH +254 722 913616 firstname.lastname@example.org|
|Iringa Regional Referral Hospital||Recruiting|
|Contact: Alice Christensen, RN MSc CNS +255 766 698 097 email@example.com|
|Rakai Health Sciences Program||Recruiting|
|Kalisizo, Rakai, Uganda|
|Contact: Godfrey Kigozi, MbChB PhD +256 701 444144 firstname.lastname@example.org|
|Principal Investigator:||Richard K Lee, MD, MBA||Weill Medical College of Cornell University|
|Principal Investigator:||Philip S Li, MD||Weill Medical College of Cornell University|