NCT06968221

Bovine Reinforcement in Stomach, Colorectal and Lung Operation

A Study on the Safety and Efficacy of Using Cingular Bovine Pericardium Anastomosis Reinforcement Membrane for Tissue Reinforcement and Hemostasis at Anastomotic Sites

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Shanghai Cingularbio Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced techniques with respect to the incidence of postoperative hemorrage rate, anastomotic leakage, if applicable.

Detailed description

This is a randomized prospective trial that compares the use of Cingular Bioabsorbable Staple Line Reinforcement to standard stapling techniques in tissue resections. The potential exists to utilize staple line reinforcement as a means of lowering the rate of post-operative hemorrage rate, anastomotic leakage.

Conditions

• Rectal Cancer Stage III
• Lung Cancer Stage III

Interventions

Type	Name	Description
DEVICE	Bioabsorbable Staple Line Reinforcemen	cingular Bioabsorbable Staple Line Reinforcement

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-09-01
• Completion: 2026-10-31
• First posted: 2025-05-13
• Last updated: 2025-05-15

Locations

1 site across 1 country: China