N/A
N=80
Use of a New Stapling Device in General Thoracic Surgery
Thoracic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05143541 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Number of Participants With Product Malfunction — 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AEON Endostapler (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lexington Medical Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Product Malfunction |
— | — |
| PRIMARY Number of Participants With Intraoperative Staple Line Bleeding |
— | — |
| PRIMARY Number of Participants With Reported Device-related Adverse Events |
— | — |
| SECONDARY Hospital Length of Stay |
3.8 | — |
| SECONDARY Chest Tube Removal |
2.1 | — |
Summary
The goal of this study was to test the safety and efficacy of this stapler in our general thoracic surgery practice.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05143541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.