Clinical trial NCT05039021: A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2021-09-09
Enrollment: 265
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Device-related Adverse Events (AEs)
timeFrame: From Day 0 up to post-procedure follow up visit (up to 28 days)
Secondary outcomes:
measure: Number of Vessels Transections With Diameter >5 to 7 mm With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
timeFrame: On the day of transection (Day 0)
measure: Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
timeFrame: On the day of transection (Day 0)
measure: Number of Grade 4 Vessel Transections Requiring Hemostasis Measures
timeFrame: On the day of transection (Day 0)
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Riley Hospital for Children at Indiana University Health
state: Indiana
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
city: Toronto
country: Canada
facility: Toronto General Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
Study officials:
affiliation: Ethicon Endo-Surgery
name: Ethicon Endo-Surgery Clinical Trial
role: STUDY_DIRECTOR
affiliation: Riley Hospital for Children at Indiana University Health
name: Troy Markel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IU Health University Hospital
name: Attila Nakeeb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de l'Universite de Montreal
name: Moishe Liberman, MD
role: PRINCIPAL_INVESTIGATOR
References: