ENSEAL X1 Curved Jaw for Upper Gastrointestinal; Lower Gastrointestinal; Gynecological.

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Upper Gastrointestinal; Lower Gastrointestinal; Gynecological.ENSEAL X1 Curved Jaw - Device
Eligibility
18+
All Sexes
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Study Summary

This trial will look at the safety and effectiveness of a new device by collecting data from people who have it used on them during standard procedures.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Intraoperative

Intraoperative
Achievement of Grade 3 or lower hemostasis for each vessel transection
Distribution of 5-point scale scores for various tasks completed by the ENSEAL X1 Curved Jaw device (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection)
Distribution of hemostasis grading scale for each vessel transected
Type, name, and number of additional hemostasis products required to achieve hemostasis for Grade 4 vessel transections

Trial Safety

Safety Progress

1 of 3

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1
Valiant PS-IDE Stent Graft
1
MANTA Vascular Closure Device
2
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Trial Design

1 Treatment Group

Upper Gastrointestinal/Lower Gastrointestinal/Gynecological
1 of 1

Experimental Treatment

164 Total Participants · 1 Treatment Group

Primary Treatment: ENSEAL X1 Curved Jaw · No Placebo Group · N/A

Upper Gastrointestinal/Lower Gastrointestinal/Gynecological
Device
Experimental Group · 1 Intervention: ENSEAL X1 Curved Jaw · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: intraoperative

Who is running the clinical trial?

Ethicon Endo-SurgeryLead Sponsor
83 Previous Clinical Trials
35,842 Total Patients Enrolled
Sergio Alfieri, MDPrincipal InvestigatorGemelli Hospital
1 Previous Clinical Trials
98 Total Patients Enrolled
Ahmar Shah, MDPrincipal InvestigatorYeovil District Hospital
Richard Skipworth, MDPrincipal InvestigatorRoyal Infirmary of Edinburgh
Anna Fagotti, MDPrincipal InvestigatorGemelli Hospital
Keith Gersin, MDPrincipal InvestigatorWake Forest University Health Sciences
4 Previous Clinical Trials
812 Total Patients Enrolled
James Hopkins, MDPrincipal InvestigatorSouthmead Hospital
Hugh Paterson, MDPrincipal InvestigatorWestern General Hospital

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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References

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