A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures

Ethicon

Status: Not yet enrolling

Conditions: Surgical Procedures, Operative

Treatments: Device: Standard of Care Stapler and Reloads; Device: ETHICON™ 4000 Stapler System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07744568

ESC202408

Details and patient eligibility

About

The purpose of this study is to compare how well the ETHICON™ 4000 Stapler works as compared to the standard stapling devices by assessing how often air leaks and bleeding along the staple line occur during lung and stomach surgeries and by evaluating the side effects occurring within 30 days of surgery.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prior to study enrollment, the participant and treating surgeon must have determined to proceed with one of the following surgical procedures as part of routine clinical care: a. A gastric procedure (sleeve gastrectomy) involving stapling of the stomach; or b. A thoracic procedure (lung resection limited to lobectomy, segmentectomy, or wedge resection) involving stapling of the lung
• Willingness to give consent and comply with all study-related evaluations and visit schedule
• At least 18 years of age

Exclusion criteria

• Physical or psychological condition which would impair study participation
• The planned procedure is a revision/ reoperation for the same indication or same anatomical location
• Trauma participants
• Any condition or clinically significant finding that, in the Investigator's judgement, may interfere with study participation, impact the assessment of endpoints, or compromise the patient's safety or welfare
• Any medical condition that the Investigator deems could impact inflammatory or immune response
• Enrollment in a concurrent interventional clinical study that could impact the study endpoints

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Standard of Care Stapler System

Active Comparator group

Description:

Eligible participants for a gastric or thoracic surgery randomized to the standard of care arm will undergo the surgical procedure with a standard of care stapler and reloads, as per instructions for use (IFU).

Treatment:

Device: Standard of Care Stapler and Reloads

ETHICON 4000 Stapler System

Experimental group

Description:

Eligible participants for a gastric or thoracic surgery randomized to the ETHICON 4000 arm will undergo the surgical procedure with the ETHICON 4000 Stapler System, as per IFU.

Treatment:

Device: ETHICON™ 4000 Stapler System