Thoracic ProcedureNCT05067647
A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
A study testing ENSEAL X1 Curved Jaw Tissue Sealer in people with Thoracic Procedure and Urologic Procedure, run by Ethicon Endo-Surgery at 6 sites in 4 countries.
Trial summary
The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Procedure, Urologic Procedure, Ear, Nose and Throat Procedure
- What is being tested?
- ENSEAL X1 Curved Jaw Tissue Sealer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 29 Nov 2021to 30 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary laparoscopic or open procedure (thoracic, urologic or ear, nose, and throat [ENT]) where at least one vessel is planned to be transected by the ENSEAL X1 curved jaw tissue sealer (ENSEAL X1) device per the Instructions for use (IFU)
- Willingness to give consent and comply with all study-related evaluations and treatment schedule
- At least 18 years of age
Who cannot join
- Physical or psychological condition which would impair study participation
- Enrollment in a concurrent interventional clinical study that could impact the study endpoints
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Japan3 sites
National Cancer Center Hospital East
Chiba
Kitasato University
Kanagawa
Kanagawa Cancer Center
Yokohama
About this study
Official title: A Prospective, Single-Arm Multi-Center Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).
- Being tested
- ENSEAL X1 Curved Jaw Tissue Sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENSEAL X1 Curved Jaw Tissue SealerDevice
ENSEAL X1 curved jaw tissue sealer is used for transecting and sealing vessels during thoracic, urologic, or ENT procedures according to instructions for use.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic, Urologic, Ear, Nose and Throat (ENT) Procedures | Experimental | Any thoracic, urologic, or ENT procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. Participants will be considered enrolled when the ENSEAL X1 device has been attempted to be used for a vessel transection during thoracic, urologic, or ENT procedures. Receives: Device: ENSEAL X1 Curved Jaw Tissue Sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
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 ENSEAL X1; 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). Here, the number of vessels that achieved <=Grade 3 hemostasis was reported.
Measured: On the day of transection (Day 0)
Number of Participants With at Least One Device-related Adverse Events (AEs)
Device-related AEs were those having a relationship of possibly, probably, or causally. 1. Possible-The relationship with use of device was weak but cannot be ruled out completely. Alternative causes were also possible. Cases where relatedness cannot be assessed, or no information had been obtained were also classified as possible. 2. Probable -The relationship with use of device seemed relevant and/or event cannot reasonably be explained by another cause, but additional information may be obtained; 3. Causal relationship-The event was associated with device or with procedures beyond reasonable doubt with event occurred such as, a known side effect; temporal relationship; involves a body-site or organ that device was applied or had an effect on; followed a known response pattern; impact on event when discontinued and reintroduced; Others; Harms due to error in use.
Measured: Baseline up to 6 weeks
Secondary outcomes (8)
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
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 adhesion removal or division by ENSEAL X1.
Measured: On the day of transection (Day 0)
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
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 lymphatics bundles division by ENSEAL X1.
Measured: On the day of transection (Day 0)
Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
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 tissue bundles division by ENSEAL X1.
Measured: On the day of transection (Day 0)
Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
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 tissue grasping by ENSEAL X1.
Measured: On the day of transection (Day 0)
Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
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 tissue cutting by ENSEAL X1.
Measured: On the day of transection (Day 0)
Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
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 tissue dissection by ENSEAL X1.
Measured: On the day of transection (Day 0)
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale
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 ENSEAL X1; 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). Here, the number of vessels that achieved Grade 1 to 4 hemostasis was reported.
Measured: On the day of transection (Day 0)
Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures Such as Sutures and Hemoclips
Percentage of grade 4 vessel transections requiring hemostasis measures such as sutures and hemoclips were reported.
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.
- First posted5 Oct 2021
- Study start29 Nov 2021
- Primary completion21 Oct 2022
- Study completion30 Nov 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic ProcedureStudies 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ethicon Endo-Surgery Clinical Trial, Study director, Ethicon Endo-Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067647
- Sponsor's protocol ID
- ENG_2020_04
- Other IDs
- ENG_2020_04
- Status last verified
- Nov 2023
- First submitted
- 24 Sep 2021
- Last updated
- 21 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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) 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
Publications
Siegel JM, Cummings JF, Clymer JW. Reproducible, repeatable and clinically-relevant hemostasis scoring. J Adv Med Pharm Sci 2014;1:30-39.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Multi-Center Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
- ClinicalTrials.gov ID
- NCT05067647
- Acronym / sponsor ID
- ENG_2020_04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Posted 21 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic, Urologic, Ear, Nose and Throat (ENT) Procedures | Experimental | Device: ENSEAL X1 Curved Jaw Tissue SealerAny thoracic, urologic, or ENT procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. Participants will be considered enrolled when the ENSEAL X1 device has been attempted to be used for a vessel transection during thoracic, urologic, or ENT procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary laparoscopic or open procedure (thoracic, urologic or ear, nose, and throat [ENT]) where at least one vessel is planned to be transected by the ENSEAL X1 curved jaw tissue sealer (ENSEAL X1) device per the Instructions for use (IFU)
- Willingness to give consent and comply with all study-related evaluations and treatment schedule
- At least 18 years of age
Key exclusion criteria (2 listed)
- Physical or psychological condition which would impair study participation
- Enrollment in a concurrent interventional clinical study that could impact the study endpoints
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 |
|---|---|---|
| ENSEAL X1 Curved Jaw Tissue SealerENSEAL X1 curved jaw tissue sealer is used for transecting and sealing vessels during thoracic, urologic, or ENT procedures according to instructions for use. | Device | Thoracic, Urologic, Ear, Nose and Throat (ENT) Procedures |
Primary outcome
Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
Time frame: On the day of transection (Day 0)
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 ENSEAL X1; 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). Here, the number of vessels that achieved <=Grade 3 hemostasis was reported.
Number of Participants With at Least One Device-related Adverse Events (AEs)
Time frame: Baseline up to 6 weeks
Device-related AEs were those having a relationship of possibly, probably, or causally. 1. Possible-The relationship with use of device was weak but cannot be ruled out completely. Alternative causes were also possible. Cases where relatedness cannot be assessed, or no information had been obtained were also classified as possible. 2. Probable -The relationship with use of device seemed relevant and/or event cannot reasonably be explained by another cause, but additional information may be obtained; 3. Causal relationship-The event was associated with device or with procedures beyond reasonable doubt with event occurred such as, a known side effect; temporal relationship; involves a body-site or organ that device was applied or had an effect on; followed a known response pattern; impact on event when discontinued and reintroduced; Others; Harms due to error in use.
8 secondary outcomes
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Time frame: On the day of transection (Day 0)
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Time frame: On the day of transection (Day 0)
Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Time frame: On the day of transection (Day 0)
Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Time frame: On the day of transection (Day 0)
Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Time frame: On the day of transection (Day 0)
Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Time frame: On the day of transection (Day 0)
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale
Time frame: On the day of transection (Day 0)
Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures Such as Sutures and Hemoclips
Time frame: On the day of transection (Day 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundSiegel JM, Cummings JF, Clymer JW. Reproducible, repeatable and clinically-relevant hemostasis scoring. J Adv Med Pharm Sci 2014;1:30-39.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) 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 Thoracic Procedure
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingObservational study
A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Cancer
Recruiting
Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer
Advanced Lung Cancer, Dyspnea
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
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENSEAL X1 Curved Jaw Tissue Sealer in people with Thoracic Procedure and Urologic Procedure, run by Ethicon Endo-Surgery at 6 sites in 4 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 3 inclusion and 2 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 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan, United States, Netherlands, 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 21 Dec 2023). 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 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 NCT05067647, which also lists 1 linked publication.
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 21 Dec 2023.