ENSEAL® G2 Articulating Tissue Sealer in Laparoscopic Colectomy
Condition: Any Condition Requiring Surgical Treatment Via Colectomy
Study type: Observational

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.
    

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
      
Keywords: laparoscopic; colectomy; ENSEAL