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

Ethicon Endo-Surgery2 sites in 1 country9 target enrollmentDecember 21, 2021

ConditionsColorectal Surgical Procedures

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Surgical Procedures
Sponsor: Ethicon Endo-Surgery
Enrollment: 9
Locations: 2
Primary Endpoint: Number of Participants with Echelon Contour Success
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 21, 2021

End Date

December 15, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ethicon Endo-Surgery

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Participants with Echelon Contour Success

Time Frame: interoperative

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?