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

Terminated

• Conditions: Colorectal Surgical Procedures
• Interventions: Device: Echelon Contour

• Registration Number: NCT05133141
• Lead Sponsor: Ethicon Endo-Surgery

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-24
• Study Start: 2021-12-21
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-07
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Echelon Contour	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants with Echelon Contour Success	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?

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Device-related Adverse Events (AEs)	28 days post-procedure	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.

Trial Locations

Locations (2)

Baylor Scott and White; 🇺🇸 Saint Louis, Missouri, United States

Washington University; 🇺🇸 Dallas, Texas, United States