Observational Study Utilizing Harmonic ACE®+7 Shears (ENG-14-002)

• Research type

  Research Study

• Full title

  Prospective, Multicenter, Observational Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Total Laparoscopic Hysterectomy.

• IRAS ID

  162913

• Contact name

  Jonathan Batiller

• Contact email

  jbatill2@its.jnj.com

• Sponsor organisation

  ETHICON

• Research summary

  The objective of this study is to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total laparoscopic hysterectomy. Vessel sealing will be quantitately assessed for transection and sealing of the uterine vasculature. Subjects =40 years with no future desire for fertility will be included in the study if they have indicated for elective total laparoscopic hysterectomy.
  Our primary endpoint is the incidence of haemostasis at the named vessel/pedicle (Uterine Artery or Uterine Pedicle) on the left and right side.
  Our secondary endpoints are incidence of haemostasis at the Ovarian pedicle on the left and/or right side, incidence of requirement for additional measures to obtain haemostasis on the UA or UP and/or OP on the left and right side, and the incidence of complications associated with vaginal cuff healing including dehiscence or separation, infection, cellulitis, abscess, inflammation, and granulation associated with each suture used as part of the study.

• REC name

  West of Scotland REC 4

• REC reference

  14/WS/1088

• Date of REC Opinion

  3 Oct 2014

• REC opinion

  Further Information Favourable Opinion