Thoracic Cancer Clinical Trial
Official title:
Use of a New Stapling Device in General Thoracic Surgery
Verified date | November 2021 |
Source | Lexington Medical Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this study was to test the safety and efficacy of this stapler in our general thoracic surgery practice.
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) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kantonsspital St. Gallen | St. Gallen |
Lead Sponsor | Collaborator |
---|---|
Lexington Medical Inc. |
Switzerland,
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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