Use of a New Stapling Device in General Thoracic Surgery

Completed

• Conditions: Thoracic Cancer
• Interventions: Device: AEON Endostapler

• Registration Number: NCT05143541
• Lead Sponsor: Lexington Medical Inc.

Brief Summary

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

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 Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-03
• Results First Submitted: 2021-12-21
• Results First Submitted QC: 2021-12-21
• Results First Posted: 2022-01-21
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AEON Endostapler	AEON Endostapler	Stapling performed with AEON Endostapler

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kantonsspital St. Gallen; 🇨🇭 St. Gallen, Switzerland