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

N/ANot Yet RecruitingNCT07744568

Ethicon Endo-Surgery300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

300

Conditions

Surgical Procedures, Operative

Interventions

ETHICON™ 4000 Stapler SystemDEVICE

The Investigator will use the ETHICON™ 4000 Stapler System, as per instructions for use (IFU). This system is composed of two primary components: The ETHICON 4000 Stapler and the ETHICON 3D Reloads.

Standard of Care Stapler and ReloadsDEVICE

The Investigator will choose a commercially available stapler and reload(s) per their professional preference produced by any manufacturer and aligned with the manufacturer's IFU. The only exception is that the Investigator may not use the ETHICON™ 4000 Stapler System.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line

Percentage of firings associated with each intraoperative grade of bleeding at the staple line (prior to prophylactic or intervention to the staple line) will be reported. The percentage of staple firings for each bleeding grade and for bleeding scores of 4 or below, 3 or below, 2 or below, 1 or below, and 0 will be estimated.

Time frame: Intraoperative

Thoracic- Percentage of Firings Associated with Intraoperative Air Leak at the Staple Line

Percentage of firings associated with intraoperative air leak at the staple line (prior to prophylactic or intervention to the staple line) will be reported.

Time frame: Intraoperative

Secondary Outcomes

Length of Hospital Stay

Number of days from the date of hospital admission to discharge from the hospital will be reported.

Time frame: Up to 30 Days Post Procedure

Gastrointestinal: Percentage of Participants Experiencing Gastric Leak Up to 30 Days Post-Procedure

Percentage of participants experiencing gastric leak occurring up to 30 days post procedure will be reported.

Time frame: Up to 30 Days Post Procedure

Thoracic: Duration of Tube Placement

Duration of chest tube placement and removal will be reported.

Time frame: Up to 30 Days Post Procedure

Thoracic: Postoperative Air Leak Duration

Postoperative air leak duration upon submersion test (prior to prophylactic or intervention to the staple line) using a binary determination (air leak, yes/no) will be reported.

Central Contacts

Kari Loing

CONTACT

(513) 337-7000 RA-ESC202408@its.jnj.com

Data from ClinicalTrials.gov

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