N/A
N=164
Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05329402 ↗Enrolled (actual)
164
Serious AEs
11.1%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With Anastomosis Success — 79; 83 Participants — p=0.9727
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler (Device); ECHELON Flex Powered Articulating Endoscopic Linear Cutters (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fengh Medical Co., Ltd.
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anastomosis Success |
79; 83 | 0.9727 |
Summary
To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by Johnson & Johnson when the Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Thoracoscopic Anatomic Lobectomy (segmentectomy)
Eligibility Criteria
Inclusion Criteria
- Subjects aged 18-70 (inclusive), with no gender limitation;
- The subject plans to undergo thoracoscopic anatomic pulmonary lobectomy (pulmonary segment);
- Subjects or their guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent.
Exclusion Criteria
- Subjects have contraindications of video-assisted thoracoscopy;
- The preoperative imaging results of the subjects indicated the presence of severe pleural adhesion and significant calcified hilar lymph nodes;
- Subjects' platelet (PLT) 1.5;
- Subjects forced expiratory volume in 1 second (FEV1)/expected value ≤50%, or forced expiratory volume in 1 second (FEV1)/use Vital capacity (FVC)≤60%;
- Cardiac ejection fraction ≤50%;
- Major organ failure or other serious diseases (including clinically relevant cardiovascular diseases or within 12 months prior to enrollment) Myocardial infarction; A history of severe neurological or psychiatric illness; The presence of a serious infection before surgery that must be controlled with medication; Dissemination of activity Sexual intravascular coagulation; At high risk of blood clots);
- The subject is a pregnant or lactating woman;
- The subject participated in clinical trials of other drugs or devices within 1 month prior to the trial;
- Other conditions that the researcher judged inappropriate for inclusion. .
Data sourced from ClinicalTrials.gov (NCT05329402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.