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

NCT05039021 | Completed Results FDA Device

• 1 other identifier: ENG_2020_06
• Study Type: interventional
• Target: 265
• Locations: 3 countries
• Sites: 7

Brief Summary

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of Vessels Transections With Diameter >5 to 7 mm With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale

  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

  On the day of transection (Day 0)

• Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale

  On the day of transection (Day 0)

• Number of Grade 4 Vessel Transections Requiring Hemostasis Measures

  On the day of transection (Day 0)

Study Arms (1)

Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)

EXPERIMENTAL

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

Interventions

HARMONIC 1100 Shears DEVICE

HARMONIC 1100 Shears is used for vessel transection according to instructions for use.

Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pediatric population:
• Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
• Less than 18 years of age at the time of procedure; and
• 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:
• 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;
• Willingness to give consent and comply with all study-related evaluations and visit schedule; and
• At least 18 years of age.

You may not qualify if:

• Preoperative
• Physical or psychological condition which would impair study participation;
• Female subjects, of childbearing age, who are pregnant; or
• Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
• Intraoperative
• \. The HARMONIC 1100 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure.

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (7)

Baptist Health

Jacksonville, Florida, 32207, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Canada

Location

Toronto General Hospital

Toronto, Canada

Location

Western General Hospital

Edinburgh, Scotland, United Kingdom

Location

Results Point of Contact

• Title: Senior Director Medical Affair-Endomechanical and Trx
• Organization: Ethicon Endo-Surgery, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Ethicon Endo-Surgery Clinical Trial

  Ethicon Endo-Surgery

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: September 9, 2021
• Study Start: July 29, 2021
• Primary Completion: February 4, 2024
• Study Completion: March 12, 2024
• Last Updated: April 30, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); US (4); CA (2)