Clinical trial NCT05133141: A Study of the ECHELON Contour Curved Cutter Stapler Device in Colorectal Procedures
Official title: A Prospective, Single-Arm, Multi-Center Study of the ECHELON ContourTM Curved Cutter Stapler Device in Colorectal Procedures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Surgical Procedures
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who plan to have an elective colorectal surgical procedure will be included.

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).


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

Primary outcomes:
measure: Number of Participants with Echelon Contour Success
timeFrame: interoperative
Secondary outcomes:
measure: Number of Participants with Device-related Adverse Events (AEs)
timeFrame: 28 days post-procedure
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Baylor Scott and White
state: Missouri
city: Dallas
country: United States
facility: Washington University
state: Texas
Study officials:
affiliation: Ethicon Endo-Surgery
name: Ethicon Endo-Surgery Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Rai P, Johnston SS, Chaudhuri R, Naoumtchik E, Pollack E. Association of Complications with Healthcare Utilization and Hospital-Borne Costs Among Patients Undergoing Open Low Anterior Resection Using Curved Cutter Staplers. Med Devices (Auckl). 2021 Mar 31;14:87-95. doi: 10.2147/MDER.S298975. eCollection 2021.
citation: Giustina A, Bevan JS, Bronstein MD, Casanueva FF, Chanson P, Petersenn S, Thanh XM, Sert C, Houchard A, Guillemin I, Melmed S; SAGIT Investigator Group. SAGIT(R): clinician-reported outcome instrument for managing acromegaly in clinical practice--development and results from a pilot study. Pituitary. 2016 Feb;19(1):39-49. doi: 10.1007/s11102-015-0681-2.