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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06968221

Enrollment

172

Registered

2025-05-13

Start date

2025-05-01

Completion date

2026-10-31

Last updated

2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer Stage III, Rectal Cancer Stage III

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 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.

Interventions

DEVICEBioabsorbable Staple Line Reinforcemen

cingular Bioabsorbable Staple Line Reinforcement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

with a bioabsorbable staple line reinforcement material compared with standard non-reinforced material

Eligibility

Sex/Gender

ALL

Age

18 Years to 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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak	1-3 months	The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 1-3 months post procedure.

Countries

China

Contacts

Primary Contactstudy director

july_s@126.com02138016387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026