A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices

A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears and Generator G11 in Pediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynecological, Urological, and Thoracic)

This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (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 1100 Shears and Generator G11 instructions for use.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Procedures; Adult Hepato-pancreato-biliary (HPB) Procedures; Adult Lower Gastrointestinal Procedures; Adult Gastric Procedures; Adult Gynecological Procedures; Adult Urological Procedures; Adult Thoracic Procedures
• Intervention / Treatment: Device: HARMONIC 1100 Shears

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristy Canavan; Phone Number: 904-443-1474; Email: kcanava2@its.jnj.com

Study Locations

• Canada
  • Montreal, Canada
    • Recruiting
    • Centre Hospitalier de l'Universite de Montreal
  • Toronto, Canada
    • Recruiting
    • Toronto General Hospital
    • Contact: Yasufuku
• United Kingdom
  • Scotland
    • Edinburgh, Scotland, United Kingdom
      • Recruiting
      • Western General Hospital
      • Contact: Leung
• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist Health
      • Contact: Morgenthal
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
      • Contact: Sundaram
    • Indianapolis, Indiana, United States, 46202
      • Completed
      • IU Health University Hospital
    • Indianapolis, Indiana, United States, 46202
      • Completed
      • Riley Hospital for Children at Indiana University Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Pediatric population:

1. Primary laparoscopic non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
2. Less than 18 years of age at the time of procedure; and
3. The subject's parent/legal guardian must be willing to give permission for the subject to participate in the study and provide written informed consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study.

Adult population:

1. Primary laparoscopic elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
2. Willingness to give consent and comply with all study-related evaluations and visit schedule; and
3. At least 18 years of age.

Exclusion Criteria:

Preoperative

1. Physical or psychological condition which would impair study participation;
2. Female subjects, of childbearing age, who are pregnant; or
3. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.

Intraoperative

1. The HARMONIC 1100 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic); Any pediatric or adult (hepato-pancreato-biliary, lower gastrointestinal, gastric, gynecological, urological, thoracic) procedures where the HARMONIC 1100 Shears is used for vessel transection according to instructions for use.	Device: HARMONIC 1100 Shears; HARMONIC 1100 Shears is used for vessel transection according to instructions for use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of vessel transections with an achievement of Grade 3 or lower for each vessel transection based on the scale described below	Grade 1: no bleeding at transection site;; Grade 2: minor bleeding at transection site, no intervention needed;; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touchups with HARMONIC 1100 Shears; or; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).	Intraoperative
Number of Participants with Device-related Adverse Events (AEs)	Number of participants with device-related (possible, probable, or causal) AEs will be reported. An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study.	2 to 6 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of 5-point scale scores for sealing and transection of lymphatic vessels completed by HARMONIC 1100 Shears	A 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) will be used to describe how satisfied the surgeon was with the sealing and transection of lymphatic vessels by HARMONIC 1100 Shears.	Intraoperative
The distribution of grades (1-4) seen from the use of the hemostasis grading scale (primary outcome measure) for each vessel transected will be calculated		Intraoperative
The number of any additional hemostasis measures required to achieve hemostasis for any Grade 4 vessel transections will be collected		Intraoperative

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Study Director: Ethicon Endo-Surgery Clinical Trial, Ethicon Endo-Surgery; Principal Investigator: Troy Markel, MD, Riley Hospital for Children at Indiana University Health; Principal Investigator: Attila Nakeeb, MD, IU Health University Hospital; Principal Investigator: Moishe Liberman, MD, Centre Hospitalier de l'Universite de Montreal

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ENG_2020_06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes