Bovine Reinforcement in Stomach, Colorectal and Lung Operation
Recruiting
Phase 3
Interventional Study
Rectal Cancer Stage III
Lung Cancer Stage III
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 172 (estimated)
- Sponsor
- Shanghai Cingularbio Co. Ltd · Industry
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About This Trial
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.
Trial Locations
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Eligibility 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 …
Contacts