Initial safety and efficacy of a novel drug-coated balloon for treatment of benign intestinal strictures.

Background and Aims: Intestinal strictures are common adverse events of chronic bowel conditions such as Crohn's disease, diverticulitis, and ulcerative colitis or after intestinal surgery. Mechanical endoscopic balloon dilation (EBD) is the standard-of-care intervention, whereas multiple, repeat EBD therapy is often needed. A novel drug-coated balloon (DCB) was developed to dilate strictures while concurrently delivering medication to reduce the rate of recurrence of strictures. We present the results of a first-in-human, observational, open-label clinical trial in small- and large-bowel strictures. Methods: Ten human adult subjects with chronic single, discrete, and benign intestinal stricture were treated and followed for 2 years. Outcomes included the Endoscopic Obstructive Score (EOS), Obstructive Symptom Score (OSS), and adverse events. Results: In the first-in-human trial of benign small- and large-bowel strictures, subjects presented with a mean stricture diameter of 10.3 mm, average EOS of 2.7, and OSS of 25.2. The technical success rate was 90%, and no participants had major treatment-related adverse events. EOS decreased to .2 on average at 6 months. At 2 years, the retreatment-free survival rate was 100% and the average OSS was .6. Subjects tolerated the procedure well. Conclusions: DCB treatment of benign small- and large-bowel strictures appears to be safe and showed durable results of decreased symptoms and freedom from recurrence through 2 years. Results warrant further investigation in large-scale clinical trials. (Clinical trial registration number: NCT03886324.).