ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision (EIMC) in Sub-Saharan Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03338699
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : October 22, 2018
Sponsor:
Collaborators:
EngenderHealth Inc.
Johns Hopkins University
Jhpiego
George Washington University
Bill and Melinda Gates Foundation
Rakai Health Sciences Program
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

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:

  1. To compare the rates of adverse events (AEs) with the ShangRing or Mogen clamp
  2. To compare pain control, time to complete wound healing and parent satisfaction with EIMC using the ShangRing or Mogen clamp
  3. To compare operative time and provider preference.
  4. To assess the rate of spontaneous ring detachment with the ShangRing as a method to decrease the need for follow-up visits after circumcision.
  5. To assess the subpreputial microbiome of the infants prior to and after the initiation of circumcision

Three correlative studies will be conducted:

  1. 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.
  2. 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.
  3. 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1380 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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 : October 2019
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: ShangRing
Topical anesthesia based, no-flip ShangRing circumcision.
Device: ShangRing
Topical anesthesia based, no-flip ShangRing circumcision.

Active Comparator: Mogen clamp
Mogen clamp circumcision.
Device: Mogen clamp
Mogen clamp circumcision




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All participants in this study are male who will undergo early infant circumcision.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male infants from 24 hours up to 60 days of life
  2. Gestational age ≥37 weeks
  3. Normal birth weight (≥2.5 Kg)
  4. No illness requiring medical treatment
  5. No penile abnormality requiring surgical repair (e.g. hypospadias, chordee)
  6. No family history of bleeding disorders
  7. Consent provided by at least one parent/legally acceptable representative (LAR) of the infant

    1. Parent or LAR must be able to understand study procedures and requirements of study participation;
    2. Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
    3. Parent or LAR must have a cell phone or access to a cell phone

Exclusion Criteria:

  • Not meeting one or more of the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338699


Contacts
Contact: Richard K Lee, MD, MBA +1 212-746-4811 ril9010@med.cornell.edu
Contact: Philip S Li, MD psli@med.cornell.edu

Locations
Kenya
Homa Bay County Teaching and Referral Hospital Not yet recruiting
Homa Bay, Kenya
Contact: Quentin Awori, MD MPH    +254 722 913616    qawori@engenderhealth.org   
Tanzania
Iringa Regional Referral Hospital Not yet recruiting
Iringa, Tanzania
Contact: Alice Christensen, RN MSc CNS    +255 766 698 097    alice.christensen@jhpiego.org   
Uganda
Rakai Health Sciences Program Recruiting
Kalisizo, Rakai, Uganda
Contact: Godfrey Kigozi, MbChB PhD    +256 701 444144    gkigozi@rhsp.org   
Sponsors and Collaborators
Weill Medical College of Cornell University
EngenderHealth Inc.
Johns Hopkins University
Jhpiego
George Washington University
Bill and Melinda Gates Foundation
Rakai Health Sciences Program
Investigators
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

Additional Information:
Publications:

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03338699     History of Changes
Other Study ID Numbers: 1611017762
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will only be shared among study investigators and authorized personnel at the designated study sites. IPD will not be shared with anyone not involved in the design, planning, or execution of the study.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Weill Medical College of Cornell University:
Early infant male circumcision
ShangRing
sub-Saharan Africa
HIV
WHO