A Study of the ECHELON Contour Curved Cutter Stapler Device in Colorectal Procedures

A Prospective, Single-Arm, Multi-Center Study of the ECHELON ContourTM Curved Cutter Stapler Device in Colorectal Procedures

The purpose of this study is to prospectively generate device-specific clinical data related to the performance of Echelon Contour per its instructions for use (IFU).

Study Overview

• Status: Terminated
• Conditions: Colorectal Surgical Procedures
• Intervention / Treatment: Device: Echelon Contour

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Baylor Scott and White
  • Texas
    • Dallas, Texas, United States, 75246
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who plan to have an elective colorectal surgical procedure will be included.

Description

Inclusion Criteria:

• Elective colorectal procedure where Echelon Contour is planned to be used for transection and resection of the colon
• Willingness to give consent and comply with all study-related evaluations and visit schedule. If the participant is less than (<) 18 years of age, the participant's parent/legal guardian must be willing to give permission for the participant to participate in the study and provide written Informed Consent for the participant. In addition, assent must be obtained from pediatric participants who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric participant is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study); the parent/legal guardian's written Informed Consent for the participant will be acceptable for the participant to be included in the study
• Anatomical region must be of sufficient size for the device to be used

Exclusion Criteria:

Preoperative

• Females who are pregnant
• Physical or psychological condition which would impair study participation
• Participant previously enrolled into the study (example: participant enrolled for Hartmann's procedure then cannot be reenrolled for the Hartmann's reversal)

Intraoperative

- Study device use not attempted

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Echelon Contour; This prospective study will include the participants who plan to have an elective colorectal surgical procedure and collect clinical data in a post-market setting. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the Echelon Contour instruction for use (IFU).	Device: Echelon Contour; There is no intervention, beyond necessary clinical care, in this study. Echelon Contour is used for transection and resection in colorectal surgical procedures per its instructions for use (IFU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Echelon Contour Success	Echelon Contour success based on surgeon responses on question 1 in the surgeon reported outcome measures (SROM) will be reported. Surgeon will be asked to choose option "Yes" or "No" for following question: Did Echelon Contour provide acceptable performance considering other therapeutic alternatives?	interoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Device-related Adverse Events (AEs)	An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study.	28 days post-procedure

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Study Director: Ethicon Endo-Surgery Clinical Trial, Ethicon Endo-Surgery

Publications and helpful links

General Publications

• Rai P, Johnston SS, Chaudhuri R, Naoumtchik E, Pollack E. Association of Complications with Healthcare Utilization and Hospital-Borne Costs Among Patients Undergoing Open Low Anterior Resection Using Curved Cutter Staplers. Med Devices (Auckl). 2021 Mar 31;14:87-95. doi: 10.2147/MDER.S298975. eCollection 2021.
• Giustina A, Bevan JS, Bronstein MD, Casanueva FF, Chanson P, Petersenn S, Thanh XM, Sert C, Houchard A, Guillemin I, Melmed S; SAGIT Investigator Group. SAGIT(R): clinician-reported outcome instrument for managing acromegaly in clinical practice--development and results from a pilot study. Pituitary. 2016 Feb;19(1):39-49. doi: 10.1007/s11102-015-0681-2.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ESC202102 (Other Identifier: Ethicon Endo-Surgery)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes