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

Abstract

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.)