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

Launched by ETHICON ENDO-SURGERY · Nov 12, 2021

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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

Trial Officials