SINGA-PACLI (Medical Device Trial)
The device trial, SINGA-PACLI, is the first Investigator-initiated, randomised-controlled trial focusing on Asians suffering from Critical Limb Ischaemia (CLI). The Trial compares drug-eluting balloons percutaneous transluminal angioplasty (DEB-PTA) with conventional balloons (CB-PTA) in below-the-knee (BTK) arterial lesions.
The Study target is to recruit 136 subjects from two Singapore sites: the Singapore General Hospital and TTSH. Being a double-blind randomised medical device trial, the Study procedure and monitoring presented complex challenges.
Given the complexity of the Trial, the SCRI Team’s investigational product management expertise was called on in the establishment of the feasibility study procedures. In addition, SCRI’s CRAs designated blinded and unblinded study roles to ensure data collected is protected and verified. The CRAs also ensure that adverse events are correctly documented and reported promptly to regulatory authorities and study investigators.