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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Ethicon Endo-Surgery
Study ID
NCT06608485
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • HARMONIC 700 Shears — DEVICE
    There is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use.

Study Details

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.

Key Dates

Start date
Jan 23, 2025
Status verified
Jun 2026
Primary completion
Jul 1, 2026
Completion
Aug 15, 2026

Study Design

Enrollment
165 participants (estimated)

Arms

  • Arm: Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears)
    This prospective study will involve collection of clinical data in a post-market setting from pediatric surgical procedures (general) and adult surgical procedures (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 700 Shears instruction for use (IFU). All subjects enrolled will be followed post-operatively through discharge and again at approximately 28 days post-surgery.

Primary Outcome Measure

Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis [ Time Frame: Intraoperative ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Riley Hospital for Children at Indiana University HealthIndianapolisIndiana46202-
NextStage Clinical ResearchWichitaKansas67214-
Icahn School of Medicine at Mt. SinaiNew YorkNew York10029-
The Methodist Hospital Research Institute D B A Houston Methodist Research InstituteHoustonTexas77030-

Find similar trials in Indianapolis, IN

By research site
Riley Hospital for Children at Indiana University Health· Indianapolis, INNextStage Clinical Research· Wichita, KSIcahn School of Medicine at Mt. Sinai· New York, NYThe Methodist Hospital Research Institute D B A Houston Methodist Research Institute· Houston, TX

Related Studies