CompletedNot Applicable

Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)

China164 participantsStarted 2018-10-22

Plain-language 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)

Who can participate

Age range18 Years – 70 Years

SexALL

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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) \<60x 10%/L or INR \> 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;

What they're measuring

Number of Participants With Anastomosis Success

Timeframe: During surgery

Trial details

NCT IDNCT05329402

SponsorFengh Medical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-11

Results submitted2023-02-16

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