A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-13

Study Completion Date

2019-08-30

Brief Summary

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This prospective, single-arm, multi-center, evaluation will collect clinical data in a post-market setting. The three types of procedures studied will be colectomy, gynecological, and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.

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Detailed Description

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The primary objective of this study is to prospectively generate device specific clinical data related to hemostasis in a post-market setting using the ENSEAL X1 per its instructions for use. There will be no blinding or planned interim analysis in this study.

Conditions

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Colectomy; Gynecological; Thoracic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Colectomy/Gynecological/Thoracic

Any colectomy/gynecological/thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.

Group Type EXPERIMENTAL

ENSEAL X1

Intervention Type DEVICE

ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.

Interventions

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ENSEAL X1

ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
2. Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
3. At least 18 years of age.