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OpenTrials
Completed

NCT Number: NCT05143541

Use of a New Stapling Device in General Thoracic Surgery

The goal of this study was to test the safety and efficacy of this stapler in our general thoracic surgery practice.

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Key information

Conditions

Thoracic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonsspital St. Gallen

Sankt Gallen, 9001, Switzerland

About this study

A prospective study was conducted with 80 consecutive thoracic cases. Stapler usage data, intraoperative outcomes, and 30-day post-operative outcomes were evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing planned VATS or open lung resection surgery (lobectomy or wedge resection)

Exclusion criteria

  • Active bacterial or fungal infection
  • Prior history of VATS or open lung surgery
  • Use of staple line reinforcement material (buttress)
  • Patients under the age of 18 on the date of the surgery
  • Any female patient who is pregnant
  • Scheduled concurrent surgical procedure other than lobectomy or wedge resection (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed)

Treatment and study plan

AEON Endostapler

Device

Surgery with AEON Endostapler

Primary outcomes

  1. Number of Participants With Product Malfunction

    Time frame: Within surgery, up to 8 hours

    Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.

  2. Number of Participants With Intraoperative Staple Line Bleeding

    Time frame: Within surgery, up to 8 hours

    Number of participants with intraoperative staple line bleeding

  3. Number of Participants With Reported Device-related Adverse Events

    Time frame: Within 30-day post-operative period

    Number of participants with reported device-related adverse events

Secondary outcomes

  1. Hospital Length of Stay

    Time frame: Following hospital admission, up to discharge

    Hospital length of stay (days)

  2. Chest Tube Removal

    Time frame: Following surgery, up to chest tube removal

    Time before chest tube removal (days)

Sponsors and collaborators

Lead sponsor

Lexington Medical Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2021
Registry last updated
Dec 29, 2022

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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