Bovine Reinforcement in Stomach, Colorectal and Lung Operation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Rectal Cancer Stage III Lung Cancer Stage III

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bioabsorbable Staple Line Reinforcement configured for circular staplers

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

Group Type EXPERIMENTAL

Bioabsorbable Staple Line Reinforcemen

Intervention Type DEVICE

cingular Bioabsorbable Staple Line Reinforcement

anastomotic staple line without reinforcement

stomach, colorectal and lung anastomotic staple line without reinforcement

Group Type ACTIVE_COMPARATOR

Bioabsorbable Staple Line Reinforcemen

Intervention Type DEVICE

cingular Bioabsorbable Staple Line Reinforcement

Interventions

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Bioabsorbable Staple Line Reinforcemen

cingular Bioabsorbable Staple Line Reinforcement

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No