Use of a New Stapling Device in General Thoracic Surgery

Lexington Medical Inc.80 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Thoracic Cancer

Interventions

AEON EndostaplerDEVICE

Surgery with AEON Endostapler

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Outcomes

Primary Outcomes

Number of Participants With Product Malfunction

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

Time frame: Within surgery, up to 8 hours

Number of Participants With Intraoperative Staple Line Bleeding

Number of participants with intraoperative staple line bleeding

Time frame: Within surgery, up to 8 hours

Number of Participants With Reported Device-related Adverse Events

Number of participants with reported device-related adverse events

Time frame: Within 30-day post-operative period

Secondary Outcomes

Hospital Length of Stay

Hospital length of stay (days)

Time frame: Following hospital admission, up to discharge

Chest Tube Removal

Time before chest tube removal (days)

Time frame: Following surgery, up to chest tube removal

Data from ClinicalTrials.gov

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