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: Completed
• 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 (Actual): 265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada
    • Centre Hospitalier de l'Université de Montréal
  • Toronto, Canada
    • Toronto General Hospital
• United Kingdom
  • Scotland
    • Edinburgh, Scotland, United Kingdom
      • Western General Hospital
• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children at Indiana University Health
    • Indianapolis, Indiana, United States, 46202
      • IU Health University Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Pediatric population:

1. 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. 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
Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale	Number of vessels transected with <= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. 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, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).	On the day of transection (Day 0)
Number of Participants With Device-related Adverse Events (AEs)	Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study device. Possible refers to the relationship with the use of the device is weak but cannot be ruled out completely; Probable refers to the relationship with the use of the device seems relevant and/or the event cannot reasonably be explained by another cause, but additional information may be obtained; Causal relationship refers to the event is associated with the device or with procedures beyond reasonable doubt.	From Day 0 up to post-procedure follow up visit (up to 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Vessels Transections With Diameter >5 to 7 mm With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale	Number of vessels transected with diameter >5 to 7 mm with <= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. 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, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).	On the day of transection (Day 0)
Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score	Number of participants using HARMONIC 1100 Shears for sealing and transection of lymphatic vessels as assessed by Surgeon Satisfaction Scale Score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for sealing and transection of lymphatic vessel by HARMONIC 1100 Shears.	On the day of transection (Day 0)
Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale	Number of vessels transected with hemostasis (Grade 1 to 4) based on hemostasis grading scale was reported. A 4-point grading scale was used to assess hemostasis in blood vessels. 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, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).	On the day of transection (Day 0)
Number of Grade 4 Vessel Transections Requiring Hemostasis Measures	Number of Grade 4 vessel transections requiring hemostasis measures such as hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products and other products were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. 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, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products). Since multiple responses were collected, sum of the data of each category exceeds the overall number of units analyzed.	On the day of transection (Day 0)

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'Université de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Actual): February 4, 2024
• Study Completion (Actual): March 12, 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 30, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

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