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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-21

Study Completion Date

2022-12-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Colorectal Surgical Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Echelon Contour

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No