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Completed

NCT Number: NCT03441178

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

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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Key information

Conditions

Colectomy; Gynecological; Thoracic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Hospital, Birmingham, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
  • At least 18 years of age.

Exclusion criteria

  • Physical or psychological condition which would impair study participation; or
  • Enrollment in a concurrent clinical study.

Treatment and study plan

ENSEAL X1

Device

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

Primary outcomes

  1. Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1

    Time frame: Intraoperative, after vessel has been transected

    • 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 monopolar device and/or touch-ups with ENSEAL X1;
    • Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Secondary outcomes

  1. Hemostasis Grading Assessment for Each Vessel Transection

    Time frame: Intraoperative, after vessel has been transected

    • 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 monopolar device and/or touch-ups with ENSEAL X1;
    • Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

  2. Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up

    Time frame: Intraoperative, after vessel has been transected

    • 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 monopolar device and/or touch-ups with ENSEAL X1;
    • Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

  3. Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used

    Time frame: Intraoperative, after vessel has been transected

    • 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 monopolar device and/or touch-ups with ENSEAL X1;
    • Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.