Use of a New Stapling Device in General Thoracic Surgery

Thoracic Cancer Clinical Trial

Official title:

Use of a New Stapling Device in General Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143541
• Other study ID #: Endostapler04
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2021
• Source: Lexington Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Thoracic Cancer

Intervention

Device:
• AEON Endostapler
Surgery with AEON Endostapler

Locations

Country	Name	City	State
Switzerland	Kantonsspital St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Lexington Medical Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants With Intraoperative Staple Line Bleeding	Number of participants with intraoperative staple line bleeding	Within surgery, up to 8 hours
Primary	Number of Participants With Reported Device-related Adverse Events	Number of participants with reported device-related adverse events	Within 30-day post-operative period
Secondary	Hospital Length of Stay	Hospital length of stay (days)	Following hospital admission, up to discharge
Secondary	Chest Tube Removal	Time before chest tube removal (days)	Following surgery, up to chest tube removal