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

Ethicon

Status: Terminated

Conditions: Colorectal Surgical Procedures

Treatments: Device: Echelon Contour

Study type: Observational

Funder types: Industry

Identifiers

NCT05133141

ESC202102 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

9 participants in 1 patient group

Echelon Contour

Description:

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).

Treatment:

Device: Echelon Contour