NCT03326895

Brief Summary

This prospective clinical study will evaluate the intra-operative performance of the powered circular stapler used in left colectomy procedures in a post-market setting.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
5 countries

12 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

October 9, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

November 20, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 11, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

October 9, 2017

Results QC Date

December 2, 2020

Last Update Submit

January 6, 2021

Conditions

Left-sided Colon Resection

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Stapler Performance Issues

    A stapler performance issue is defined as a failure of the ECHELON CIRCULAR Powered Stapler to perform per its instructions for use. This includes but is not limited to difficulty placing or removing the stapler, stapler misfire/failure of the device to fully fire, staple line defects, incomplete or thin donuts, tissue damage, positive intraoperative leak test, detached components, unformed staples, or any other device failure.

    Intraoperative

Secondary Outcomes (1)

  • SURG-TLX Questionnaire

    Collected postoperative for intraoperative stress

Study Arms (1)

Group 1

EXPERIMENTAL

Powered circular stapler used to complete anastomosis of colon

Device: Left-sided colon resection

Interventions

Left-sided colon resectionDEVICE

Left-sided colon resection with powered stapler

Group 1

Eligibility Criteria

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

You may qualify if:

  • Scheduled for colectomy with left-sided anastomosis peformed with a circular stapler;
  • Willing to give consent and comply with all study-related evaluations; and
  • At least 18 years of age.

You may not qualify if:

  • Enrollment in a concurrent clinical study;
  • Pregnancy;
  • Physical or psychological condition which would impair study participation;
  • Emergency surgery;
  • ASA Class ≥ IV;
  • The subject is judged unsuitable for study participation by the Investigator; or
  • Unable or unwilling to provide follow-up information 8, Undergoing multiple intraoperative synchronous colon resections;
  • \. Anastomosis not distal from splenic flexure of the colon 10. Anastomosis of the colon not attempted 11. Subjects with any intraoperative findings identified by the surgeon that would preclude attempting an anastomosis with a circular stapler.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Alabama Birmingham

Birmingham, Alabama, 35294-0016, United States

Location

Colon & Rectal Clinic of Orlando

Orlando, Florida, 32806, United States

Location

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

Spectrum Health System

Grand Rapids, Michigan, 49503, United States

Location

Mt. Sinai Hospital / Mt. Sinai School of Medicine

New York, New York, 10029, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Schon Klinik Neustadt

Neustadt, 23730, Germany

Location

Hospital Universitario Virgen Rocio

Seville, 41013, Spain

Location

University Hospitals Birmingham NHS

Birmingham, B15 2TH, United Kingdom

Location

St Jame's University Hospital

Leeds, LS9 7TF, United Kingdom

Location

St. Mary's Hospital

London, United Kingdom

Location

Related Publications (1)

  • Herzig DO, Ogilvie JW, Chudzinski A, Ferrara A, Ashraf SQ, Jimenez-Rodriguez RM, Van der Speeten K, Kinross J, Schimmelpenning H, Sagar PM, Cannon JA, Schwiers ML, Singleton DW, Waggoner JR, Fryrear R 2nd, Sylla P. Assessment of a circular powered stapler for creation of anastomosis in left-sided colorectal surgery: A prospective cohort study. Int J Surg. 2020 Dec;84:140-146. doi: 10.1016/j.ijsu.2020.11.001. Epub 2020 Nov 8.

    PMID: 33176211RESULT

Results Point of Contact

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

Study Officials

  • Daniel Herzig, MD

    Oregon Health and Science 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

October 9, 2017

First Posted

October 31, 2017

Study Start

November 20, 2017

Primary Completion

December 6, 2019

Study Completion

January 15, 2020

Last Updated

January 11, 2021

Results First Posted

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Primary endpoint

Locations

BE(1)ES(1)DE(1)US(6)GB(3)