Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

Ethicon

Status: Completed

Conditions: Lung Resection Procedures; Gastric Procedures

Treatments: Device: Staple Line Reinforcement

Study type: Interventional

Funder types: Industry

Identifiers

NCT04544865

ESC_2018_03

Details and patient eligibility

About

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.

Full description

The primary objective of this study is to prospectively generate clinical data on device-related adverse events in a post-market setting using ECHELON ENDOPATH Staple Line Reinforcement per its instructions for use. There will be no blinding in this study. An interim analysis is planned for sample-size re-estimation.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  1. 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
  2. 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:

1. Physical or psychological condition which would impair study participation;

2. Body mass index (BMI) ≥ 46.0 kg/m2;

3. The procedure is a revision/reoperation for the same indication or same anatomical location;

4. A procedure where extended wound or organ support is required;

5. Any medical condition that the investigator deems could impact inflammatory or immune response;

6. Concurrent treatment with medications that the investigator deems could have influence on wound healing;

7. History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or

8. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.

   • Intraoperative:

9. Per surgeon discretion, presence of adhesions that could lead to an increased risk of leak occurrence at a different location than the staple line.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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240 participants in 1 patient group

Gastric and thoracic staple line reinforcement

Experimental group

Description:

ECHELON ENDOPATH Staple Line Reinforcement is used during a gastric or thoracic procedure.

Treatment:

Device: Staple Line Reinforcement