Thoracic Cancer
Conditions
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.
Interventions
DEVICEAEON Endostapler
Surgery with AEON Endostapler
Sponsors
Lexington Medical Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AEON Endostapler Stapling performed with AEON Endostapler
AEON Endostapler: Surgery with AEON Endostapler | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | AEON Endostapler | — |
|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 12.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 38 Participants | — |
| Sex: Female, Male Male | 42 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
Primary
Number of Participants With Intraoperative Staple Line Bleeding
Number of participants with intraoperative staple line bleeding
Time frame: Within surgery, up to 8 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AEON Endostapler | Number of Participants With Intraoperative Staple Line Bleeding | 0 Participants |
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.
Time frame: Within surgery, up to 8 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AEON Endostapler | Number of Participants With Product Malfunction | 0 Participants |
Primary
Number of Participants With Reported Device-related Adverse Events
Number of participants with reported device-related adverse events
Time frame: Within 30-day post-operative period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AEON Endostapler | Number of Participants With Reported Device-related Adverse Events | 0 Participants |
Secondary
Chest Tube Removal
Time before chest tube removal (days)
Time frame: Following surgery, up to chest tube removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AEON Endostapler | Chest Tube Removal | 2.1 days | Standard Deviation 2.7 |
Secondary
Hospital Length of Stay
Hospital length of stay (days)
Time frame: Following hospital admission, up to discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AEON Endostapler | Hospital Length of Stay | 3.8 days | Standard Deviation 3.2 |