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NCT Number: NCT06968221

Bovine Reinforcement in Stomach, Colorectal and Lung Operation

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.

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Key information

Conditions

Rectal Cancer Stage III Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer Stage III Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Renji hospital affiliated to Shanghai jiaotong Uni school of medicine

Shanghai, China

Location status: Recruiting

Location contact

study director

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioabsorbable Staple Line Reinforcemen

Device

cingular Bioabsorbable Staple Line Reinforcement

Primary outcomes

  1. Proportion of Subjects Who Experience a hemorrage

    Time frame: 10 min

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

Secondary outcomes

  1. Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

study director

CONTACT

[email protected]

02138016387

Sponsors and collaborators

Lead sponsor

Shanghai Cingularbio Co. Ltd

Industry

Collaborators

  • RenJi Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 13, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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