RecruitingOBSERVATIONAL

A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures

This study is checking a surgical tool called HARMONIC 700 Shears. It's designed to seal blood vessels safely and effectively during different types of operations. Researchers want to ensure it performs as expected and is safe to use in everyday hospital practice. They're looking at its use in both adults and children undergoing various surgical procedures, including general, gynaecological, urological, and chest surgeries. If you or your child are having surgery where this tool might be used, you could be asked to take part. The study helps doctors make sure new equipment is continually monitored for safety and effectiveness after it's become available.

At a glance

Status

Recruiting

Sponsor

Ethicon Endo-Surgery

Enrolment target

165

Start

23 Jan 2025

Estimated completion

15 Aug 2026

Pediatric Surgical Procedures Adult Surgical Procedures Adult Gynecological Procedures Adult Urological Procedures Adult Thoracic Procedures

What is this study about?

This study is focused on a specific surgical tool called HARMONIC 700 Shears. You can think of it like a special pair of scissors that not only cuts but also helps to seal blood vessels at the same time. This sealing action is important because it can reduce bleeding during surgery, which makes the procedure safer and potentially quicker.

The main goal of this study is to closely watch and record how well these HARMONIC 700 Shears work in real-life operations and to confirm they are safe for patients. This is a "post-market" study, meaning the device is already in use, but doctors want to collect more information about its performance and safety in a wide range of surgeries and patients, including children.

By gathering this information, healthcare professionals can be confident that the HARMONIC 700 Shears are a reliable and safe option for patients needing surgery. This ongoing check helps ensure that medical devices continue to meet high standards for patient care and allows for any necessary improvements or adjustments.

Key takeaways

This study observes a surgical tool called HARMONIC 700 Shears.
It aims to confirm the device's safety and how well it works during surgery.
It's for both adults and children having various types of planned operations.
No new treatments or procedures are involved; it's about collecting information.
Participation helps improve knowledge for future patient care.
You can stop participating at any point without it affecting your treatment.

Who may be eligible?

To join this study, patients need to be having a planned, non-emergency operation where the HARMONIC 700 Shears are expected to be used to seal at least one blood vessel. This includes a variety of adult surgeries like general, women's health, urinary, and chest operations.

For children, they must be under 18 years old and also having a planned operation where the tool will be used. A parent or legal guardian would need to agree and give written permission for their child to take part.

You wouldn't be able to join if you have a health condition that would make it difficult to take part, if you are pregnant, or if you are already in another clinical study that might affect the results of this one. Also, if the HARMONIC 700 Shears aren't actually used during the surgery for sealing a blood vessel, you wouldn't be included in the study data.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you, or is your child, having a planned, non-emergency operation?
Is it expected that HARMONIC 700 Shears will be used during the surgery to seal blood vessels?
Are you (if an adult) not pregnant?
Are you or your child not currently involved in another clinical study that might interfere with this one?
If it's for a child, is a parent or guardian able to give permission?

Answer every question to see your result.

What does participation involve?

If you or your child are eligible and agree to take part, the HARMONIC 700 Shears device would be used during your planned surgery as part of the normal procedure. There wouldn't be any extra appointments or medication specifically for the study. The doctors would simply observe and record information about how the device performed during the operation. This process would last only for the duration of the surgical procedure itself, and there's no long-term follow-up required specifically for the study.

Potential risks and benefits

Taking part in this study means your healthcare team would collect information about the performance of a surgical tool already being used in your operation. There are no direct personal benefits expected from participating, as the device is being used as part of your standard care. However, your participation helps doctors gather important safety and performance information that can benefit future patients. The risks associated with this study are those already present with your surgery, as no new procedures or medicines are being introduced. You are always free to withdraw your consent to participate at any time without it affecting your medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Riley Hospital for Children at Indiana University Health
Verified postcode
Indianapolis, United States· Completed
NextStage Clinical Research
Verified postcode
Wichita, United States· Withdrawn
Icahn School of Medicine at Mt. Sinai
Verified postcode
New York, United States· Completed
The Methodist Hospital Research Institute D B A Houston Methodist Research Institute
Verified postcode
Houston, United States· Withdrawn
Centre Hospitalier de l'Universite de Montreal
Verified postcode
Montreal, Canada· Recruiting
Dorset County Hospital Nhs Foundation Trust
Verified postcode
Dorchester, United Kingdom· Completed
Western General Hospital
Verified postcode
Edinburgh, United Kingdom· Completed
Southampton General Hospital
Verified postcode
Southampton, United Kingdom· Recruiting
Yeovil District Hospital
Verified postcode
Yeovil, United Kingdom· Recruiting

Common questions

What is the HARMONIC 700 Shears?

It's a special surgical tool that cuts and seals blood vessels at the same time, helping to reduce bleeding during operations.

Does this study involve new treatments?

No, this study is observing a medical device that is already in use during standard surgical procedures and gathering more information about its performance and safety.

Will I or my child receive a different type of care if we join?

No, you or your child will receive the same standard surgical care. The study just involves collecting information about how the HARMONIC 700 Shears perform during that care.

Who can take part?

Adults or children having a planned surgery where HARMONIC 700 Shears are expected to be used to seal blood vessels.

What if I change my mind after agreeing to participate?

You are free to withdraw from the study at any time without it affecting your medical care.

How to find out more

Kristy Canavan

kcanava2@its.jnj.com 904-443-1474 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.