Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 75

Using bioabsorbable staples to improve surgery outcomes for rectal and lung cancer

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

Run by Shanghai Cingularbio Co. Ltd · NCT06968221 · Data updated 2026-11-12

This study is testing if using special dissolvable staples during stomach, colorectal, and lung surgeries can help patients have fewer complications after their operations compared to regular staples.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment172 (estimated)
SponsorShanghai Cingularbio Co. Ltd
Industry-sponsored
Locations1 site (Shanghai)
StatusRecruiting
StartedMay 1, 2025
Main results expectedSeptember 1, 2025
Study endsOctober 31, 2026
Registry record updatedMay 15, 2025
Trial IDNCT06968221 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients scheduled for stapled stomach or colorectal surgeries who can provide informed consent.

Probably not a fit

Patients with significant intraoperative complications, collagen vascular diseases, or uncontrolled infections may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a bioabsorbable staple line reinforcement material in comparison to standard stapling techniques during stomach, colorectal, and lung surgeries. It is a randomized, prospective multicenter study aimed at reducing postoperative complications such as hemorrhage and anastomotic leakage. Participants will be monitored for outcomes related to these complications following their surgeries. The study seeks to determine if the new reinforcement material can provide better surgical results.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative complications for patients undergoing surgery for rectal and lung cancer.

How similar studies have gone: While the use of bioabsorbable materials in surgical procedures is gaining interest, this specific application in colorectal and lung surgeries is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Renji hospital affiliated to Shanghai jiaotong Uni school of medicine
    Shanghai, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.