Bovine Reinforcement in Stomach, Colorectal and Lung Operation

NCT06968221 | Recruiting Phase 3

• 1 other identifier: BSLR-2024-01
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer Stage III; Lung Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Who Experience a hemorrage

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

  10 min

Secondary Outcomes (1)

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

  1-3 months

Study Arms (2)

Bioabsorbable Staple Line Reinforcement configured for circular staplers

EXPERIMENTAL

stomach, Colorectal and lung anastomotic staple line reinforcement with Bioabsorbable Staple Line Reinforcement configured for circular staple

Device: Bioabsorbable Staple Line Reinforcemen

anastomotic staple line without reinforcement

ACTIVE COMPARATOR

stomach, colorectal and lung anastomotic staple line without reinforcement

Device: Bioabsorbable Staple Line Reinforcemen

Interventions

Bioabsorbable Staple Line Reinforcemen DEVICE

cingular Bioabsorbable Staple Line Reinforcement

Bioabsorbable Staple Line Reinforcement configured for circular staplers; anastomotic staple line without reinforcement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Cingularbio Co. Ltd: lead
• RenJi Hospital: collaborator

Study Sites (1)

Renji hospital affiliated to Shanghai jiaotong Uni school of medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

study director

CONTACT

02138016387; july_s@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CN (1)