Actively Recruiting
A Study on the Safety and Efficacy of Using Cingular Bovine Pericardium Anastomosis Reinforcement Membrane for Tissue Reinforcement and Hemostasis at Anastomotic Sites
Led by Shanghai Cingularbio Co. Ltd · Updated on 2025-05-15
172
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
S
Shanghai Cingularbio Co. Ltd
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and outcomes of using a bioabsorbable staple line reinforcement material during surgeries involving stomach, colorectal, and lung anastomoses. This randomized, prospective, multicenter study compares this reinforcement technique to standard stapling methods to see if it reduces the rate of postoperative bleeding and anastomotic leakage. The study is sponsored by Shanghai Cingularbio Co. Ltd and is conducted in a Phase 3 setting. Participants will receive one of two surgical approaches: either the anastomotic staple line is reinforced with the Cingular Bioabsorbable Staple Line Reinforcement configured for circular staplers, or the staple line is created without reinforcement using standard techniques. The trial focuses on tissue resections performed with these methods to evaluate their impact on surgical outcomes. During the study, participants will be monitored for the occurrence of hemorrhage within 10 minutes after surgery and for clinical or radiologic signs of anastomotic leaks within 1 to 3 months following the procedure. Follow-up visits will assess these outcomes as well as overall safety. The total participation period spans from surgery through the follow-up timeline. Researchers will collect data on postoperative bleeding, leaks, and adverse events to determine the comparative safety and efficacy of the reinforcement device.
CONDITIONS
Brief Title
Bovine Reinforcement in Stomach, Colorectal and Lung Operation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who will undergo operation with stapled stomach, colorectal anastomosis with or without reinforcement
- Subjects willing to accept informed consent and willing to attend the follow up
You will not qualify if you...
- Subjects who have significant intraoperative hypotension or cardiac events
- Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values)
- Subjects have uncontrolled intra-abdominal infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 minutes during surgery plus immediate post-operative period
Participants undergo stomach, colorectal, or lung surgery with stapled anastomosis, either with or without the bioabsorbable staple line reinforcement device. Immediate post-operative care is provided following surgery.
Duration - 1 to 3 months
Participants are monitored for clinical and radiologic signs of anastomotic leakage and hemorrhage after surgery.
Approximately 1 to 3 follow-up visits
Trial Site Locations
Total: 1 location
1
Renji hospital affiliated to Shanghai jiaotong Uni school of medicine
Shanghai, China
Actively Recruiting
Research Team
S
study director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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