Hemostatic Efficacy and Safety of the Hybrid Injector ClearCoajet in Endoscopic Mucosal Resection of Large Colorectal...

We aimed to evaluate the effectiveness and safety of ClearCoajet, a device that combines the hemostatic function of a heat probe with an injector, for hemostasis of intraprocedural bleeding (IPB) during colon endoscopic mucosal resection.

This multicenter, randomized clinical trial, conducted from October 2022 to April 2025, enrolled patients undergoing EMR for non-pedunculated colorectal polyps measuring ≥ 15 mm. This study evaluated and compared the efficacy and safety of hemostasis for IPB by comparing a snare-tip-only strategy (control group) with a strategy in which hemostasis could be performed using either the snare tip or ClearCoajet at the endoscopist's discretion (Coajet group).

A total of 220 lesions were included in the study, with 106 and 114 lesions assigned to the Coajet and control groups, respectively. IPB occurred in 24.1% of EMR procedures, the majority of which were classified as mild cases. Hemostasis was attempted using the assigned interventions for each group. The hemostasis success rate was slightly higher in the Coajet group (96.4% [27/28]) than in the control group (84.0% [21/25]), although the difference was not statistically significant (P = 0.176). The risk difference in hemostasis success was 12.4 percentage points (95% CI, - 4.7 to 31.3). Among the 27 successful cases in the Coajet group, 17 were controlled using ClearCoajet and 10 using the snare tip. No significant differences were observed between the two groups in terms of hemostasis time, post-polypectomy syndrome, or delayed bleeding.

In this trial, a ClearCoajet-available strategy was non-inferior to a snare-tip-only strategy, with ClearCoajet effectively controlling most bleeding episodes in that group without additional hemostatic devices. Given the smaller-than-planned sample, this finding should be confirmed in an adequately powered trial.

www.

gov NCT05737017.