RECRUITING

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

Description

The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.

Conditions

Pediatric Surgical ProceduresAdult Surgical ProceduresAdult Gynecological ProceduresAdult Urological ProceduresAdult Thoracic Procedures
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Related Conditions:

Pediatric Surgical ProceduresAdult Surgical ProceduresAdult Gynecological ProceduresAdult Urological ProceduresAdult Thoracic Procedures

Study Overview

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Study Details

Study overview

The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.

A Prospective, Single-Arm Multi-Center Study of the HARMONIC™ 700, 5 mm Diameter Shears With Advanced Hemostasis in Pediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynecological, Urological, and Thoracic)

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

Condition
Pediatric Surgical Procedures
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana, United States, 46202

Wichita

NextStage Clinical Research, Wichita, Kansas, United States, 67214

New York

Icahn School of Medicine at Mt. Sinai, New York, New York, United States, 10029

Houston

The Methodist Hospital Research Institute D B A Houston Methodist Research Institute, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
  • * Less than 18 years of age at the time of procedure
  • * Participant's parent/legal guardian must give permission to participate in the study and provide written informed consent for the participant Adult participants
  • * Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
  • * Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
  • * Physical or psychological condition which would impair study participation
  • * Participants of childbearing potential who are pregnant
  • * Enrollment in a concurrent interventional clinical study that could impact the study endpoints Intraoperative
  • * HARMONIC 700 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure

Ages Eligible for Study

to 110 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ethicon Endo-Surgery,

Ethicon Endo-Surgery, Inc. Clinical Trial, STUDY_DIRECTOR, Ethicon Endo-Surgery, Inc.

Study Record Dates

2026-08-15