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| ID | Type | Description | Link |
|---|---|---|---|
| ESC202102 | Other Identifier | Ethicon Endo-Surgery |
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This clinical study was terminated due to low recruitment.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echelon Contour | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Echelon Contour Success | 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? | interoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Device-related Adverse Events (AEs) | 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. | 28 days post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
Preoperative
Intraoperative
- Study device use not attempted
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Participants who plan to have an elective colorectal surgical procedure will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Ethicon Endo-Surgery Clinical Trial | Ethicon Endo-Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott and White | St Louis | Missouri | 63110 | United States | ||
| Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33833593 | Background | 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. | |
| 26377024 | Background |
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Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| Dallas |
| Texas |
| 75246 |
| United States |
| 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. |