ETHICON™ 4000 Stapler for Surgical Procedures
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new surgical stapler, the ETHICON™ 4000 Stapler System, to determine if it performs better than standard staplers during lung and stomach surgeries. Researchers will check for air leaks and bleeding along the staple line and monitor any side effects within 30 days after surgery. Suitable candidates for this trial include those planning to undergo stomach or lung surgeries involving stapling, such as a sleeve gastrectomy or specific lung resections. As an unphased trial, this study offers patients the chance to contribute to innovative surgical advancements.
What prior data suggests that the ETHICON™ 4000 Stapler System is safe for surgical procedures?
Research has shown that the ETHICON™ 4000 Stapler System is safe for surgery. It has approval for use in both open and laparoscopic surgeries in the European Union, indicating its safety. The stapler accommodates different tissue thicknesses, reducing complications during surgery.
Another study demonstrated that similar staplers have low rates of leaks at the surgical join, a major concern in surgeries. This finding suggests that the ETHICON 4000 Stapler System may offer similar safety.
While specific side effects for this stapler are not detailed, its approval in major regions and design features suggest it is generally well-tolerated. However, discussing any concerns with a healthcare provider is always advisable.12345Why are researchers excited about this trial?
The ETHICON™ 4000 Stapler System is unique because it introduces innovative stapling technology for gastric or thoracic surgeries, distinguishing itself from the standard of care staplers. Unlike traditional staplers, which rely on established mechanisms, the ETHICON™ 4000 aims to enhance precision and reduce complications during surgical procedures. Researchers are excited about this system because it could improve surgical outcomes, leading to faster recovery times and fewer post-surgical complications for patients.
What evidence suggests that the ETHICON™ 4000 Stapler is effective for surgical procedures?
Research has shown that the ETHICON™ 4000 Stapler System, which participants in this trial may receive, can help reduce complications during surgeries. One study found that this stapler decreased bleeding along the staple line by 23% compared to regular staplers. Surgeons have reported satisfaction with the device's performance and its ability to create a more secure staple line. Additionally, powered staplers like the ETHICON™ 4000 have been associated with fewer bleeding issues in lung surgeries. These findings suggest that the ETHICON™ 4000 Stapler may improve surgical outcomes by reducing common problems like bleeding. Participants in this trial will be randomized to receive either the ETHICON™ 4000 Stapler System or the Standard of Care Stapler System for their surgical procedures.678910
Who Is on the Research Team?
Gianluca Casali, MD
Principal Investigator
Ethicon Endo-Surgery
Are You a Good Fit for This Trial?
This trial is for adults who are scheduled to have lung or stomach surgery and need a stapling device during their procedure. People with certain health conditions that could interfere with the study may not be able to participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo gastric or thoracic surgery using either the ETHICON™ 4000 Stapler System or standard stapling devices
Follow-up
Participants are monitored for side effects and complications such as air leaks and bleeding for up to 30 days post-procedure
What Are the Treatments Tested in This Trial?
Interventions
- ETHICON™ 4000 Stapler System
- Standard of Care Stapler and Reloads
Trial Overview
The study compares the new ETHICON™ 4000 Stapler System to standard staplers used in surgeries, looking at how often air leaks and bleeding happen along the staple line within 30 days after gastric or thoracic (lung) procedures.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ethicon Endo-Surgery
Lead Sponsor
Kevin Lobo
Ethicon Endo-Surgery
Chief Executive Officer since 2012
MBA from McGill University
Dr. Afable
Ethicon Endo-Surgery
Chief Medical Officer since 2005
MD from Loyola Stritch School of Medicine
Citations
A Study Comparing ETHICON™ 4000 Stapler System With ...
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 ...
The stapling system features ETHICON™ 3D Reloads ...
elevates stapler performance to address common complications and reduced staple line interventions due to bleeding by 23% compared to ...
3.
jnjmedtech.com
jnjmedtech.com/en-US/news/press-releases/johnson-johnson-announces-ce-mark-approval-for-the-new-ethicon-4000-stapler/Johnson & Johnson Announces CE Mark Approval for the ...
Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered versus manual endoscopic surgical staplers.
4.
ctv.veeva.com
ctv.veeva.com/study/a-study-comparing-ethicon-4000-stapler-system-with-standard-of-care-stapling-devices-in-adults-undeA Study Comparing ETHICON™ 4000 Stapler System With ...
The purpose of this study is to compare how well the ETHICONTM 4000 Stapler works as compared to the standard stapling devices by assessing how ...
Dr. Kelvin Higa on ETHICON 4000 Stapler and ...
Dr. Higa discusses his positive experience with the product, stating it's a significant improvement its ability to create a cleaner staple line ...
Outcomes associated with the use of a new powered circular ...
Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered versus manual endoscopic surgical staplers.
Reusable Surgical Stapler Market Research Report 2033
Life cycle analysis studies demonstrate that a quality reusable surgical stapler can withstand 300 to 500 complete sterilization cycles, translating to multi- ...
Surgical Stapling | Ethicon
The ECHELON CIRCULARTM Powered Stapler demonstrated anastomotic leak rates of 1.8% and 1.7% in two clinical studies.†2 Leaks are a major surgical concern,
Wound Closure Market Size, Share & Industry Report [2034]
... ETHICON 4000 Stapler in the U.S. market. This ... Surgeries ... The results stated that the minimally invasive weight loss procedure is safe for bariatric surgery.
10.
indianpharmapost.com
indianpharmapost.com/medical-device/johnson-johnson-wins-eu-nod-for-next-gen-surgical-stapler-19912Johnson & Johnson wins EU nod for next-gen surgical ...
The ETHICON 4000 Stapler and ETHICON 3D Reloads are now approved for use in both open and laparoscopic surgeries across the European Union.
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