Observational Study Utilizing Harmonic ACE®+7 Shears (ENG-14-001)

• Research type

  Research Study

• Full title

  Prospective, Multicenter, Observational Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Laparascopic Colectomy.

• IRAS ID

  158348

• Contact name

  Jonathan Batiller

• Contact email

  jbatill2@its.jnj.com

• Sponsor organisation

  ETHICON

• Duration of Study in the UK

  0 years, 5 months, 0 days

• 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 laparascopic colectomy. Vessel sealing will be quantitatively assessed for transection and sealing of the inferior mesenteric artery (IMA) and the inferior mesenteric vein (IMV) (if identified).
  Subjects =18 years will be included in the study if they have indicated for elective laparoscopic colectomy with a planned dissection and transection of the IMA.
  Our primary endpoint is the incidence of haemostasis of the IMA where 'Yes' is defined as a single activation of the Advanced Haemostasis Mode on the device. Our secondary endpoints are incidence of haemostasis of the IMV, incidence of the requirement for additional measures to obtain haemostasis on the IMA or IMV and incidence of use of addtional treatment after first pass haemostasis has already been achieved at the IMA or IMV.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  14/SW/1076

• Date of REC Opinion

  10 Oct 2014

• REC opinion

  Further Information Favourable Opinion