RECRUITING

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

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Conditions

Pediatric Surgical ProceduresAdult Surgical ProceduresAdult Gynecological ProceduresAdult Urological ProceduresAdult Thoracic Procedures

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-01-23
Study Completion:2026-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06608485

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.

Ages Eligible for Study:Not specified to 110 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
  2. * Less than 18 years of age at the time of procedure
  3. * Participant's parent/legal guardian must give permission to participate in the study and provide written informed consent for the participant Adult participants
  4. * 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
  5. * 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
  1. * Physical or psychological condition which would impair study participation
  2. * Participants of childbearing potential who are pregnant
  3. * Enrollment in a concurrent interventional clinical study that could impact the study endpoints Intraoperative
  4. * HARMONIC 700 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure

Contacts and Locations

Study Contact

Study Contact
CONTACT
904-443-1474
kcanava2@its.jnj.com

Principal Investigator

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

Study Locations (Sites)

Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
United States
NextStage Clinical Research
Wichita, Kansas, 67214
United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
United States
The Methodist Hospital Research Institute D B A Houston Methodist Research Institute
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Ethicon Endo-Surgery

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-23
Study Completion Date2026-08-15

Study Record Updates

Study Start Date2025-01-23
Study Completion Date2026-08-15

Terms related to this study

Additional Relevant MeSH Terms

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