Pediatric ProceduresNCT05039021

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

A study testing HARMONIC 1100 Shears in people with Pediatric Procedures and Adult Hepato-pancreato-biliary (HPB) Procedures, run by Ethicon Endo-Surgery at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures, Adult Lower Gastrointestinal Procedures
What is being tested?: HARMONIC 1100 Shears
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 265 participants
Where: 7 sitesin 3 countries
Study dates: 29 Jul 2021to 12 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

United States4 sites

Indiana University
Indianapolis, Indiana, 46202
IU Health University Hospital
Indianapolis, Indiana, 46202
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
Baptist Health
Jacksonville, Florida, 32207

Other trials in United States

Canada2 sites

Centre Hospitalier de l'Universite de Montreal
Montreal
Toronto General Hospital
Toronto

Other trials in Canada

United Kingdom1 site

Western General Hospital
Edinburgh, Scotland

Other trials in United Kingdom

About this study

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)

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
Being tested: HARMONIC 1100 Shears

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05039021
Study group	Role	What they receive
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. Receives: Device: HARMONIC 1100 Shears

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: On the day of transection (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 202112 Mar 2024

First posted9 Sep 2021
Study start29 Jul 2021
Primary completion4 Feb 2024
Study completion12 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pediatric ProceduresStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05039021
Sponsor's protocol ID: ENG_2020_06
Status last verified: Apr 2025
First submitted: 5 Aug 2021
Last updated: 30 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Purse String Versus Conventional Wound Closure Techniques in Children Undergoing Stoma Reversal
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All Pediatric Procedures trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05039021
Acronym / sponsor ID: ENG_2020_06
Conditions: Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures, Adult Lower Gastrointestinal Procedures, Adult Gastric Procedures, Adult Gynecological Procedures, Adult Urological Procedures
Study type: Interventional
Recruitment status: Completed
Enrolment: 265 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: 29 Jul 2021 (actual)
Primary completion: 4 Feb 2024 (actual)
Study completion: 12 Mar 2024 (actual)
First posted: 9 Sep 2021 (actual)
Results: Posted 12 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)	Experimental	Device: HARMONIC 1100 ShearsAny 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

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.
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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HARMONIC 1100 ShearsHARMONIC 1100 Shears is used for vessel transection according to instructions for use.	Device	Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)

Primary outcome

Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
Time frame: On the day of transection (Day 0)
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).
Number of Participants With Device-related Adverse Events (AEs)
Time frame: From Day 0 up to post-procedure follow up visit (up to 28 days)
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.

4 secondary outcomes

Number of Vessels Transections With Diameter >5 to 7 mm With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
Time frame: 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
Time frame: On the day of transection (Day 0)
Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
Time frame: On the day of transection (Day 0)
Number of Grade 4 Vessel Transections Requiring Hemostasis Measures
Time frame: On the day of transection (Day 0)

Results and safety

Results posted to the registry on 12 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HARMONIC 1100 Shears	265	261

Primary outcome: Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale

Time frame: On the day of transection (Day 0). Count of units. Unit: Vessels transected

Measure	HARMONIC 1100 Shears n = 265
Value	484

Population analysed: Full analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel. Here, "Overall number of units analyzed" signifies total number of vessels transected and analyzed for this outcome measure.

Primary outcome: Number of Participants With Device-related Adverse Events (AEs)

Time frame: From Day 0 up to post-procedure follow up visit (up to 28 days). Count of participants. Unit: Participants

Measure	HARMONIC 1100 Shears n = 265
Value	5

Population analysed: Safety analysis set included participants in whom the HARMONIC 1100 Shears was utilized during the surgical procedure to transect at least one vessel.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 0 up to post-procedure follow up visit (Up to 28 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HARMONIC 1100 Shears	16 of 265 (6%)	69 of 265 (26%)	1 of 265

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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

Related trials for Pediatric Procedures

Active, not recruiting
Versius Paediatrics Study
Robotic Surgical Procedures in Pediatric Urology
Enrolling by invitation
Adolescent Surgery Roadmap Feasibility and Acceptability Study
Pediatric Surgical Procedures
Not yet recruiting
Purse String Versus Conventional Wound Closure Techniques in Children Undergoing Stoma Reversal
Purse-String Suture, Wound Closure Technique
Active, not recruitingObservational study
Machine Learning-Based Prediction of Postoperative Pain After Pediatric Ambulatory Surgery
Pain, Acute Post-Operative, Ambulatory Surgical Procedures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ethicon Endo-Surgery Clinical Trial study director

Ethicon Endo-Surgery

Troy Markel, MD principal investigator

Riley Hospital for Children at Indiana University Health

Attila Nakeeb, MD principal investigator

IU Health University Hospital

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HARMONIC 1100 Shears in people with Pediatric Procedures and Adult Hepato-pancreato-biliary (HPB) Procedures, run by Ethicon Endo-Surgery at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale (time frame: On the day of transection (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05039021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.