GIE Medical said that it has initiated two clinical trials in the US to evaluate ProTractX3 TTS DCB, the company’s multi-stage drug-coated balloon (DCB) technology.
According to the clinical stage company, the first trial will study the use of the investigational balloon technology for the treatment of benign esophageal strictures.
The multicenter randomised controlled clinical trial dubbed PAclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture – Esophagus (PATENT-E) will assess the safety and efficacy of the device.
Another trial called PAclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture – Bowel (PATENT-B) will investigate the safety and efficacy of ProTractX3 DCB for the treatment of benign bowel strictures.
GIE Medical said that its investigational balloon is coated with paclitaxel, a chemotherapeutic agent.
GIE Medical chief operating officer Peter Barnett said: “This technology could truly impact patient care and quality of life, and our initial use cases mark the first time this groundbreaking technology has been used in the United States.”
In the PATENT-E trial, patients will be randomly grouped to receive either the ProTractX3 DCB or standard-of-care endoscopic dilation.
PATENT-E will compare the number of participants who show improvement of dysphagia symptoms without clinically driven repeat intervention between arms at six months after treatment. Besides, the study will compare the rate of treatment-related major adverse incidents during the 30 days after treatment.
In the PATENT-B trial, patients will be randomly grouped to receive either the investigational balloon or standard-of-care endoscopic dilation.
PATENT-B will compare the rate of anatomic success between the patient groups at six months after treatment, as measured by the ability to pass a pediatric colonoscope through the treated area without considerable resistance.
GIE Medical said that the rate of major adverse events following the treatment will be compared between the two patient groups 30 days after treatment.
The clinical-stage company said that the first patients in the trials have already been treated and enrollment is going on across the US.
