N/A
N=240
Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement
Gastric Procedures · Lung Resection Procedures
Bottom Line
View on ClinicalTrials.gov: NCT04544865 ↗Enrolled (actual)
240
Serious AEs
10.8%
Results posted
Dec 2023
Primary outcome: Primary: Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures — 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Staple Line Reinforcement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures |
0; 1; 0 | — |
| PRIMARY Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days |
0; 0 | — |
| SECONDARY Number of Study Devices Replaced During Surgery |
0; 3; 0; 1; 7; 3 | — |
| SECONDARY Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback |
0; 1; 0; 1; 3; 1 | — |
| SECONDARY Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback |
0; 0; 0; 0; 0; 0 | — |
Summary
This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON ENDOPATH Staple Line Reinforcement instructions for use.
Eligibility Criteria
Inclusion Criteria
- Primary procedure (gastric or lung resection) where the ECHELON SLR is planned to be used for reinforcement of staple lines per the IFU in either a or b:
- Gastric procedures limited to laparoscopic gastric resection, robotic laparoscopic gastric resection, partial gastrectomy, gastric wedge resection, subtotal gastrectomy, laparoscopic Roux-en-Y gastric bypass, and robotic laparoscopic gastric bypass; or
- Lung resection procedures that include lobectomy, segmentectomy or wedge resection, and lung volume reduction surgery, and may be video assisted thoracic surgery (VATS) or open procedures;
- Willingness to give consent and comply with all study-related evaluations and visit schedule; and
- At least 18 years of age.
Exclusion Criteria
- Preoperative:
- Physical or psychological condition which would impair study participation;
- Body mass index (BMI) ≥ 46.0 kg/m2;
- The procedure is a revision/reoperation for the same indication or same anatomical location;
- A procedure where extended wound or organ support is required;
- Any medical condition that the investigator deems could impact inflammatory or immune response;
- Concurrent treatment with medications that the investigator deems could have influence on wound healing;
- History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or
- Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
- Intraoperative:
- Per surgeon discretion, presence of adhesions that could lead to an increased risk of leak occurrence at a different location than the staple line.
Data sourced from ClinicalTrials.gov (NCT04544865). 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.