Trial reportThe Lancet. Global health2022
ShangRing versus Mogen clamp for early infant male circumcision in eastern sub-Saharan Africa: a multicentre, non-inferiority, adaptive, randomised controlled trial.
Trial report in The Lancet. Global health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03338699 (Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision), which is not on this map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of the ShangRing vs. Mogen Clamp for Early Infant Male Circumcision (EIMC) in Sub-Saharan Africa
Who cites it
9 citing papers in PubMed, 8 citations in OpenAlex.
- Cost comparison of the ShangRing device versus Mogen clamp for early infant male circumcision in Sub-Saharan Africa.PloS one · 2026Trial
- Safety and efficacy of the ShangRing for early infant male circumcision in the routine clinical setting.BMJ global health · 2025Trial
- Comparison of the penile microbiome in infant male circumcision: Mogen clamp versus Shangring.EBioMedicine · 2024Trial
- Circumcision with a novel metallic disposable clamp (AlisklampPediatric surgery international · 2026Article
- Successful Penile Replantation Following Amputation During Neonatal Circumcision: Case Report and Systematic Review.Plastic and reconstructive surgery. Global open · 2026Article
- Ex Vivo Human Foreskin Tissue Circumcision via High-Frequency Electric Welding.Bioengineering (Basel, Switzerland) · 2026Article
- A modified Shang Ring circumcision surgical technique under local anesthesia for penile torsion in children.Translational andrology and urology · 2025Article
- Biological welding: a rapid and bloodless approach to circumcision.World journal of urology · 2024Article
- Safety, Complications, and Procedural Efficiency of Neonatal Circumcision Devices: A Network Meta-Analysis.International braz j urol : official journal of the Brazilian Society of UrologyReview
Corrections and comments
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Authors and funding
28 authors at 9 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUse of medical devices represents a unique opportunity to facilitate scale-up of early infant male circumcision (EIMC) across sub-Saharan Africa. The ShangRing, a circumcision device prequalified by WHO, is approved for use in adults and adolescents and requires topical anaesthesia only. We aimed to investigate the safety and efficacy of the ShangRing versus the Mogen clamp for EIMC in infants across eastern sub-Saharan Africa.
methodsIn this multicentre, non-inferiority, open-label, randomised controlled trial, we enrolled healthy male infants (aged <60 days), with a gestational age of at least 37 weeks and a birthweight of at least 2·5 kg, from 11 community and referral centres in Kenya, Tanzania, and Uganda. Infants were randomly assigned (1:1) by a computer-generated text message service to undergo EIMC by either the ShangRing or the Mogen clamp. The primary endpoint was safety, defined as the number and severity of adverse events (AEs), analysed in the intention-to-treat population (all infants who underwent an EIMC procedure) with a non-inferiority margin of 2% for the difference in moderate and severe AEs. This trial is registered with Clinical. TRIALS: gov, NCT03338699, and is complete.
findingsBetween Sept 17, 2018, and Dec 20, 2019, a total of 1420 infants were assessed for eligibility, of whom 1378 (97·0%) were enrolled. 689 (50·0%) infants were randomly assigned to undergo EIMC by ShangRing and 689 (50·0%) by Mogen clamp. 43 (6·2%) adverse events were observed in the ShangRing group and 61 (8·9%) in the Mogen clamp group (p=0·078). The most common treatment-related AE was intraoperative pain (Neonatal Infant Pain Scale score ≥5), with 19 (2·8%) events in the ShangRing and 23 (3·3%) in the Mogel clamp group. Rates of moderate and severe AEs were similar between both groups (29 [4·2%] in the ShangRing group vs 30 [4·4%] in the Mogen clamp group; difference -0·1%; one-sided 95% CI upper limit of 1·7%; p=0·89). No treatment-related deaths were reported.
interpretationUse of the ShangRing device for EIMC showed safety, achieved high caregiver satisfaction, and did not differ from the Mogen clamp in other key measures. The ShangRing could be used by health systems and international organisations to further scale up EIMC across sub-Saharan Africa.
fundingBill & Melinda Gates Foundation.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.