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

NCT05133141 | Terminated FDA Device

• 1 other identifier: ESC202102
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Colorectal Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants with Device-related Adverse Events (AEs)

  28 days post-procedure

Study Arms (1)

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

Interventions

Echelon Contour DEVICE

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).

Echelon Contour

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (2)

Baylor Scott and White

St Louis, Missouri, 63110, United States

Location

Washington University

Dallas, Texas, 75246, United States

Location

Related Publications (2)

• 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.

  PMID: 33833593 BACKGROUND

• 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.

  PMID: 26377024 BACKGROUND

Study Officials

• Ethicon Endo-Surgery Clinical Trial

  Ethicon Endo-Surgery

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: December 21, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)