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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05143541
Other study ID # Endostapler04
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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