Stoma Creation

PROCEDURE3 trials

Sponsors

SafeHeal Inc, JSR Medical Co., Ltd.

Conditions

Anastomotic LeakageColorectal CancerColorectal SurgeryIleostomy - StomaRectal CancerRectal TumorRectal/Anal

Unknown Phase

SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study

TerminatedNCT05010850

SafeHeal IncColorectal Cancer, Rectal/Anal, Rectal Cancer +1

Start: 2022-01-17End: 2024-01-19Updated: 2025-07-03

Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy

RecruitingNCT05826743

JSR Medical Co., Ltd.Anastomotic Leakage, Colorectal Cancer, Colorectal Surgery +2

Start: 2023-12-04End: 2028-03-15Target: 256Updated: 2026-08-05

SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study

CompletedNCT06540807

SafeHeal IncColorectal Cancer

Start: 2024-07-31End: 2025-12-26Updated: 2026-05-20

Related Papers

Safety and Performance of the Colovac Anastomosis Protection Device. A Pooled Analysis of Prospective Studies Compared With Diverting Loop Ileostomy (SAFE-2025)

Annals of Surgery2026-09-02

Performance and safety of the Colovac 2 colorectal anastomotic protection device: the SafeHeal SAFE-2023 study.

2026-03-05

<scp>SafeHeal</scp> Colovac Colorectal Anastomosis Protection Device evaluation (<scp>SAFE</scp>‐2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device

Colorectal Disease2024-05-153 citations