ENSEAL® G2 Articulating Tissue Sealer in Laparoscopic Colectomy
Completed
Conditions studied: Any Condition Requiring Surgical Treatment Via Colectomy
In brief
The primary objective of this clinical study is to describe the initial clinical experience with ENSEAL® G2 Articulating Tissue Sealer in laparoscopic colectomy, quantifying and/or qualifying how its articulation feature enables optimization of vessel sealing through improved access, approach, and visibility. This is an observational study of device usage being conducted to report initial experience with the ENSEAL ART device. It is not intended as hypothesis testing.
Key facts
- Study ID
- NCT02044770
- Run by
- Ethicon Endo-Surgery
- People needed
- 29
- Starts
- 2014-01-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2015-04-29
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult participants (age ≥ 18 and < 80 years of age, on the day of the procedure
- Scheduled to undergo one of the following planned colectomies, anticipated to be performed laparoscopically:
- a. Right colectomy; b. Left hemicolectomy; c. Transverse colectomy; d. Sigmoidectomy; e. Total colectomy; or f. Subtotal colectomy. f. Subtotal colectomy.
You may not qualify if…
- Unable or unwilling to sign the study informed consent form;
- Previous colectomy and/or proctectomy;
- Anticipated combinations of laparoscopic colectomy and low anterior resection, except in cases in which the lower anterior resection is intended to be done with an energy device other than the ENSEAL® G2 Articulating Tissue Sealer;
- Any previous major surgery of the colon that, in the opinion of the surgeon, may increase the risk of intraoperative conversion to open surgery;
- Surgery planned to be performed using a single port;
- Surgery planned to be performed with a hand-assisted device;
- Requiring emergency surgery;
- Likely to require an energy tissue sealer/dissector with a shaft larger than 35cm during surgery;
Where it is running
- Franciscan St. Francis Health — Indianapolis, Indiana, United States
- Jersey Shore University medical Center — Neptune City, New Jersey, United States
- The Christ Hospital — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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