amSafeX catheter and placement-confirmation components.
THE CLINICAL NEED
The problem behind the design.
Unintended balloon inflation in the urethra is one recognised cause of catheter-related injury. Placement safety depends on the device, the operator and the clinical situation—not any single feature.
THE GOMIDA APPROACH
The design approach
amSafeX incorporates an obturator and pull-ring mechanism intended to provide a check on balloon position. Its purpose is to support the clinician at a critical step in catheterisation.
Position confirmation
A mechanical design focused on verifying balloon position during inflation.
Familiar care setting
An indwelling-catheter approach intended for use by appropriately trained healthcare professionals.
Clinical evaluation
The design has been described in a published prospective study involving 125 participants.
EVIDENCE & CURRENT STATUS
125 participants in a published clinical study.
Mandhani and colleagues reported a prospective, non-randomised study of 100 men and 25 women. No urethral injuries, peri-catheter leakage or adverse events were reported during catheterisation. The paper was published in Urology Video Journal in 2025.
This is a limited, non-randomised dataset, not proof of zero risk or superiority. Two authors were affiliated with UnivLabs. Gomida reports commercial availability and CDSCO approval in India; ask for current documentation for the exact model.
Start with intended use, the exact configuration and evidence relevant to your setting.
Which material, French size and two- or three-way configuration fits the intended use?
What training, instructions for use and difficult-catheterisation protocol are required?
What current regulatory documents and clinical evidence cover the supplied model?
A FEW CLEAR ANSWERS
Frequently asked questions
Does it make catheterisation risk-free?+
No. The study reports what happened in its participants; it cannot guarantee safety in every patient. Training, clinical judgement and the device instructions remain essential.
Is it available to purchase?+
Gomida reports commercial availability in India. Contact the team to confirm the exact model, current approval, supply and training arrangements.
Where can I read the study?+
The original paper is linked below. It describes verification of balloon position during inflation; it is not evidence that the catheter prevents infection or every form of urethral injury.
Reviewed 8 November 2026. Product images and company descriptions: Gomida. Clinical guidelines provide context, not endorsement of a Gomida device. This page is educational and does not replace professional assessment, current device instructions or local protocols.
UNIVLABS