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Tissue Sealer

ENSEAL X1 Curved Jaw Tissue Sealer for Thoracic Surgery

N/A
Waitlist Available
Research Sponsored by Ethicon Endo-Surgery
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 weeks
Awards & highlights

Study 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).

Eligible Conditions
  • Urology Procedure
  • Ear, Nose and Throat Procedure
  • Thoracic Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With at Least One Device-related Adverse Events (AEs)
Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
Secondary outcome measures
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Thoracic, Urologic, Ear, Nose and Throat (ENT) ProceduresExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ENSEAL X1 Curved Jaw Tissue Sealer
2021
N/A
~100

Find a Location

Who is running the clinical trial?

Ethicon Endo-SurgeryLead Sponsor
83 Previous Clinical Trials
35,716 Total Patients Enrolled
Ethicon Endo-Surgery Clinical TrialStudy DirectorEthicon Endo-Surgery
3 Previous Clinical Trials
418 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
2021. "A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067647.
~28 spots leftby Apr 2025
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