Results from the prospective, non-randomized study titled, "Treatment of Barrett’s Esophagus with a novel focal cryoablation device: a safety and feasibility study" were published in the latest edition of the scientific journal Endoscopy.
The multicenter study presented data from 62 ablations in 39 patients with BE with and without advanced dysplasia (cellular signs of advanced progression towards cancer), who were treated with Coldplay Cryoballoon Focal Ablation System.
Three doses of ablation (6 seconds, 8 seconds, and 10 seconds) were tested, and post-ablation symptoms related to the system were recorded. At 2 months, patients received a follow-up endoscopy where investigators took biopsy samples of the areas of ablation. Resolution of the Barrett’s tissue to normal tissue was investigated.
Results showed no major adverse events, no strictures, and little to no patient pain. On the areas that were targeted for ablation for 10 seconds, regeneration from Barrett’s to normal tissue was seen to be 100% complete.
The trial was conducted at 8 centers in the US and Europe. The purpose of this international study was to assess the safety, feasibility, and performance of C2’s Coldplay Cryoballoon Focal Ablation System in patients with BE.
"The results of this trial are very encouraging and an important step in continued clinical assessment of C2 Therapeutics’ promising technology to treat BE," said Bas Weusten, MD, Professor of Innovative Gastrointestinal Endoscopy and Senior Gastroenterologist, St. Antonius Hospital Nieuwegein, The Netherlands, and trial’s Principal Investigator.
Barrett’s Esophagus develops as a result of chronic injury from gastroesophageal reflux disease (GERD). Over time, the normal esophageal lining is replaced with abnormal cells (Barrett’s Esophagus), putting patients at greater risk of developing cancer of the esophagus.
"C2 Therapeutics is excited to have these outstanding results published in such a prominent journal such as Endoscopy," said Peter Garcia-Meza, President and CEO of C2 Therapeutics. "The impressive data mark C2’s commitment of providing physicians with exciting new technologies backed with robust clinical data for their esophageal disease patients."
