Clinical trial NCT02044770: ENSEAL® G2 Articulating Tissue Sealer in Laparoscopic Colectomy
Official title: Initial Clinical Experience With the ENSEAL® G2 Articulating Tissue Sealer in Laparoscopic Colectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Any Condition Requiring Surgical Treatment Via Colectomy
Keywords: laparoscopic
colectomy
ENSEAL
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2014-01-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants (age ≥ 18 and \< 80 years of age, on the day of the procedure), scheduled to undergo a planned colectomy, anticipated to be performed laparoscopically

Brief summary: 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.

Detailed description: The ENSEAL® G2 Tissue Sealer is a sterile, single-patient use surgical instrument used to coagulate and transect vessels up to and including 7mm in diameter and tissue and/or vascular bundles. In preclinical research using ENSEAL tissue sealers, burst pressures were 51% higher for perpendicularly sealed vessels than for angled seals (p\<0.001) and the seal length was the primary variable in determining burst pressure (Voegele AC, 2013). These results suggest that the strongest possible seal may be obtained when vessels are approached perpendicularly and not at an angle.

However, desired angles for vessel sealing cannot always be obtained in the surgical field, especially in laparoscopic surgery due mostly to the fixed nature of the abdominal wall cannulas and the lack of adequate articulating hemostatic tools.

Since strong vessel seals are important for adequate homeostasis, the value of an articulating vessel-sealing device primarily resides in its ability to maneuver around corners and behind structures in confined spaces. An articulating vessel-sealing device would maximize the ability to approach vessels or bundles in a perpendicular manner to provide greater seal strength.

ENSEAL ART is the first articulating advanced bipolar device that can facilitate laparoscopic surgery through a 5mm port. The instrument shaft, can achieve up to 110 degrees of articulation (which improves the visibility of the tip of the device's jaw) to gain access to tissue in challenging anatomy, especially in deep/tight spaces, and facilitate additional angles to transect and seal tissue, vessels, and vascular bundles.

The articulation feature and improved ergonomics of the ENSEAL ART may provide the ability to maneuver around corners and behind structures, while making it easier to capture the full vessel in a single bite. These features may lead to a reduction of the number of ports, the instrument exchanges between ports, the need to pass the energy device to an assistant, and the number of times the surgical table tilt has to be changed during certain laparoscopic surgical procedures (e.g., colectomy).

This study focuses primarily in reporting initial user-centered interactions with the ENSEAL ART device. The users of the device will be board-certified colorectal surgeons, who will use it in an actual clinical setting (i.e., laparoscopic colectomies).

After obtaining Institutional Review Board approval, the study sites will begin recruitment of study participants.

At each of the participating study sites, 8 to 14 participants will undergo a laparoscopic colectomy using the ENSEAL ART for vessel dissection and sealing, according to the institution's standard approach.

Video recordings from the laparoscope and external cameras will capture all device activations completed with the ENSEAL ART device using articulation vs. straight (without articulating). After each surgical case, PIs will complete a survey related to the perceived advantages of the articulating features of ENSEAL ART in the context of their experience using non-articulation tissue sealers. PIs will also complete an assessment (using a validated tool) of the perceived workload of the use of the ENSEAL ART device.

The digital video recording of the surgical procedure will be evaluated by a consultancy group - Design Science Consulting Inc. (Philadelphia, PA), specializing in the conduct of field research of the variables pre-established by the protocol. Design Science is a third party reviewer, not associated with any of the study sites.

Subject-related data to be collected is limited to age, gender, diagnosis, Medical History, and adverse events associated to the use of the device.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Number of articulated activations
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
measure: Number and percent of perpendicular transections of vessels
timeFrame: Intraoperative
Locations:
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Neptune
country: United States
facility: Jersey Shore University medical Center
state: New Jersey
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
Study officials:
References:
citation: Glenn S. Parker MD, Ben M. Tsai MD, Dipen C. Maun MD, Janice F. Rafferty MD, Michael J. Stamos MD, Edward G. Chekan MD, Michael Schwiers, and Mario Gutierrez (2015)