NCT03441178

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

March 13, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 16, 2020

Completed
Last Updated

September 16, 2020

Status Verified

August 1, 2020

Enrollment Period

1.4 years

First QC Date

February 15, 2018

Results QC Date

July 22, 2020

Last Update Submit

August 25, 2020

Conditions

Colectomy; Gynecological; Thoracic

Outcome Measures

Primary Outcomes (1)

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

    * 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).

    Intraoperative, after vessel has been transected

Secondary Outcomes (3)

  • Hemostasis Grading Assessment for Each Vessel Transection

    Intraoperative, after vessel has been transected

  • Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up

    Intraoperative, after vessel has been transected

  • Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used

    Intraoperative, after vessel has been transected

Study Arms (1)

Colectomy/Gynecological/Thoracic

EXPERIMENTAL

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

Device: ENSEAL X1

Interventions

ENSEAL X1DEVICE

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

Colectomy/Gynecological/Thoracic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

Yeovil District Hospital

Yeovil, BA21 4AT, United Kingdom

Location

Results Point of Contact

Title
Jason Waggoner, PhD
Organization
Ethicon Endo-Surgery
jwaggon1@its.jnj.com
+1 513.337.8310

Study Officials

  • Bruce Robb, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 22, 2018

Study Start

March 13, 2018

Primary Completion

August 14, 2019

Study Completion

August 30, 2019

Last Updated

September 16, 2020

Results First Posted

September 16, 2020

Record last verified: 2020-08

Locations

US(1)GB(5)