Bovine Reinforcement in Stomach, Colorectal and Lung Operation

NCT06968221 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Cingularbio Co. Ltd

Phase

Phase 3

Started

2025-05-01

Last updated

2025-05-15

Condition(s) studied

Rectal Cancer Stage IIILung Cancer Stage III

Investigational drug(s) / intervention(s)

Bioabsorbable Staple Line Reinforcemen

Bioabsorbable Staple Line Reinforcemen: cingular Bioabsorbable Staple Line Reinforcement

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Proportion of Subjects Who Experience a hemorrage — 10 min
The primary endpoint for the study is the proportion of subjects who experience a hemorrage through 10 min post procedure.

Trial sites (1)

Facility	City	Region	Status
Renji hospital affiliated to Shanghai jiaotong Uni school of medicine	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06968221 on ClinicalTrials.gov ↗ ← All trials in China