Status:
RECRUITING
Bovine Reinforcement in Stomach, Colorectal and Lung Operation
Lead Sponsor:
Shanghai Cingularbio Co. Ltd
Collaborating Sponsors:
RenJi Hospital
Conditions:
Rectal Cancer Stage III
Lung Cancer Stage III
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 l...
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT06968221
Start Date
May 1 2025
End Date
October 31 2026
Last Update
May 15 2025
Active Locations (1)
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1
Renji hospital affiliated to Shanghai jiaotong Uni school of medicine
Shanghai, China