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NCT06968221RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
172 (estimated)
First submitted
5 May 2025
Start date
1 May 2025
Primary completion date
1 Sept 2025
Lead sponsor
Shanghai Cingularbio Co. Ltd
NCT number
NCT06968221

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 172
  • From 1 May 2025 to the primary completion date, 1 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Subjects who have significant intraoperative hypotension or cardiac events.
  • Subjects have uncontrolled intra-abdominal infection

Lab values

  • Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values).

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Renji hospital affiliated to Shanghai jiaotong Uni school of medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.