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.

Study Overview

• Status: Completed
• Conditions: Thoracic Cancer
• Intervention / Treatment: Device: AEON Endostapler

Detailed Description

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 (Actual): 80

Contacts and Locations

Study Locations

• Switzerland
  • St. Gallen, Switzerland, 9001
    • Kantonsspital St. Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

80 subjects meeting inclusion criteria

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AEON Endostapler; Stapling performed with AEON Endostapler	Device: AEON Endostapler; Surgery with AEON Endostapler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Reported Device-related Adverse Events	Number of participants with reported device-related adverse events	Within 30-day post-operative period
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.	Within surgery, up to 8 hours
Number of Participants With Intraoperative Staple Line Bleeding	Number of participants with intraoperative staple line bleeding	Within surgery, up to 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Hospital length of stay (days)	Following hospital admission, up to discharge
Chest Tube Removal	Time before chest tube removal (days)	Following surgery, up to chest tube removal

Collaborators and Investigators

• Sponsor: Lexington Medical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: Endostapler04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes