18 and older, any sex, with Left-sided Colon Resection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Stapler Performance IssuesPrimary· Intraoperative
A stapler performance issue is defined as a failure of the ECHELON CIRCULAR Powered Stapler to perform per its instructions for use. This includes but is not limited to difficulty placing or removing the stapler, stapler misfire/failure of the device to fully fire, staple line defects, incomplete or thin donuts, tissue damage, positive intraoperative leak test, detached components, unformed staples, or any other device failure.
Group
Value
95% CI
ECHELON CIRCULAR Powered Stapler
11.9
7.4 – 17.8
SURG-TLX QuestionnaireSecondary· Collected postoperative for intraoperative stress
The Surgery Task Load index (SURG-TLX) questionnaire was completed by the participating surgeon following each procedure. The questionnaire was used to provide an assessment of surgical stress (surgeon) associated with the procedure (defined as the creation of the anastomosis).
There are six specific components (mental, physical, temporal, task, situational, and distractions) that are used for evaluating the surgeon experience after each surgery is performed. Each component is scored on a 0 to 100 scale with lower scores representing a "low" response on that component and higher scores indica
Overall Score
Group
Value
95% CI
ECHELON CIRCULAR Powered Stapler
38.0
± 21.60
Mental Demands (How mentally fatiguing was the procedure?)
Group
Value
95% CI
ECHELON CIRCULAR Powered Stapler
44.9
± 27.8
Physical Demands (How physically fatiguing was the procedure?)
Group
Value
95% CI
ECHELON CIRCULAR Powered Stapler
37.9
± 26.5
Temporal Demands (How hurried or rushed was the pace of the procedure?)
Group
Value
95% CI
ECHELON CIRCULAR Powered Stapler
30.3
± 22.6
Task Complexity (How complex was the procedure?)
Group
Value
95% CI
ECHELON CIRCULAR Powered Stapler
50.3
± 28.6
Situational Stress (How anxious did you feel while performing the procedure?)
Group
Value
95% CI
ECHELON CIRCULAR Powered Stapler
38.6
± 27.3
Distractions (How distracting was the operating environment?)
Group
Value
95% CI
ECHELON CIRCULAR Powered Stapler
26.5
± 21.0
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 Weeks Post Procedure.
Reporting threshold: 1.2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This prospective clinical study will evaluate the intra-operative performance of the powered circular stapler used in left colectomy procedures in a post-market setting.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Left-sided Colon Resection
Currently open trials in the same condition.
NCT07351071 — Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Res
· NA
· recruiting
Other Ethicon Endo-Surgery trials
Trials by the same sponsor.
NCT06608485 — A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
· recruiting
NCT05519215 — A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures
· completed
NCT05133141 — A Study of the ECHELON Contour Curved Cutter Stapler Device in Colorectal Procedures
· terminated
NCT05067647 — A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (E
· NA
· completed
NCT05039021 — A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ethicon Endo-Surgery
Last refreshed: 11 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03326895.