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OpenTrials
Completed

NCT Number: NCT07354854

Evaluation of the Safety and Effectiveness of the Tri-staple Technology inThoracic Surgery Clinical Investigation

The goal of this post-market clinical study is to evaluate the safety and effectiveness of the tri-staple technology in thoracic surgery. The main question it aims to answer is to validate its efficacy, safety and operationalperformance for lung applications.

Participants will undergoing thoracic surgery.

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Key information

Conditions

Lung Cancer (Diagnosis) Disease Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, 321000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older than 18 years old, male or female;
  • Subjects are scheduled to undergo open or thoracoscopic puimonary surgery with any surgicalprocedure;
  • The surgery is performed using the easyEndotm Lite Linear Cuting Stapler for Single Use andLoading Unites for Single Use for tissue cutting and suturing.

Exclusion criteria

  • Non-elective surgery;
  • Previous surgical operation on the ipsilateral lung;
  • Pregnant or lactating women;
  • Patients who, in the judgment of the investigator, are unsuitable to participate in the study for other reasons.

Treatment and study plan

thoracic surgery

Device

thoracic surgery using the easyEndo™ Lite Linear Cuting Stapler for Single Use and Loading Unites for Single Use for tissue cutting and suturing.

Primary outcomes

  1. Anastomosis success rate

    Time frame: Perioperative/Periprocedural

    Tissue transection andanastomosis are performed during the procedure, and the device is withdrawn after a successful trigger, and the cutting anastomosis line is carefully checked for integrity and air leakage. if the anastomosis is complete and there is no air leakage, the anastomosis is considered successful.other wise it is considered failed.

Secondary outcomes

  1. operative time

    Time frame: Perioperative/Periprocedural

  2. intra-operative blood loss

    Time frame: Perioperative/Periprocedural

  3. post-operative air leak

    Time frame: Perioperative/Periprocedural

  4. incidence of conversion to open surgery due to stapler-related issues

    Time frame: Perioperative/Periprocedural

  5. complication

    Time frame: Perioperative/Periprocedural

Sponsors and collaborators

Lead sponsor

Ezisurg Medical Co. Ltd.

Other

Collaborators

  • Jinhua Municipal Central Hospital

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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