Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH)

This study has been completed.
ERBE Elektromedizin GmbH
Information provided by (Responsible Party):
Bernhard Kraemer, University Hospital Tuebingen Identifier:
First received: December 4, 2012
Last updated: December 14, 2012
Last verified: December 2012

The aim of the study is the evaluation of the efficiency and safety of the new, CE-certified thermofu-sion and dissection instrument BiCision® in comparison with the long established Ultracision® Har-monic Scalpel(Ethicon)during a laparoscopic supracervical hysterectomy (LASH).

Condition Intervention
Uterine Bleeding Disorders
Benign Uterine Conditions
Focus: Comparison of Two Instruments
Device: BiCision®
Device: Ultracision® Har-monic Scalpel(Ethicon)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH): A Prospective, Controlled, Randomized, Non-inferiority in Vivo Human Study.

Resource links provided by NLM:

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Operation time [ Time Frame: Participants will be followed for the duration of hospital stay, an expexted average of 8 months ] [ Designated as safety issue: No ]
    The primary objective is the operation time for each preparation side and instrument needed from the beginning of the removal of the cornual structure of the uterus (uterine cornu) till the completely removal of the parametric tissue directly before removal of the corpus uteri from the cervix.

Enrollment: 30
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BiCision Arm
Coagulation with BiCision
Device: BiCision®
Active Comparator: Ultracision Arm
Coagulation with Ultracision
Device: Ultracision® Har-monic Scalpel(Ethicon)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age > 18
  • gender: female
  • indication for laparoscopic supracervical hysterectomy with no adnexectomyor other surgery
  • will and the capability to comply the study requirements
  • signed informed consent

Exclusion Criteria:

  • Invasive malignome in the pelvis
  • Cardiac pacemaker or implanted defibrilator if no informations are available about the compatibil-ity with RF energy
  • Abnormal blood parameters (values less than factor 0.8 or more than 1.25 compared to the val-ues of creatinine and standard hemogram)
  • Abnormal coagulation parameters: PTT > 40 sec. and / or Quick's-Value< 50% (the use of antiplateletsup to a max. of 100mg/d is no exclusion criteria)
  • Inability to understand the purpose of the study
  • status after a laparotomy by a longitudinal incision
  • intraabdominal adhesions (at the beginning of the surgery ≥ 5 sectioning for adhesiolysis)
  • open laparoscopy required
  • different anatomical situations that yields to different surgery requirements
  • conspicuous PAP, cervixmyoma or endometriosis of the rectovaginale space
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01752725

University Hospital
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
ERBE Elektromedizin GmbH
Study Chair: Diethelm Wallwiener, Professor University Hospital Tuebingen
Principal Investigator: Bernhard Krämer, MD University Hospital Tuebingen
  More Information

No publications provided

Responsible Party: Bernhard Kraemer, Executive / Investigator, University Hospital Tuebingen Identifier: NCT01752725     History of Changes
Other Study ID Numbers: 04122012
Study First Received: December 4, 2012
Last Updated: December 14, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
supracervical hysterectomy
vessel sealing
bipolar electrocoagulation

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Uterine Hemorrhage
Cardiovascular Diseases
Genital Diseases, Female
Hematologic Diseases
Hemorrhagic Disorders
Pathologic Processes
Uterine Diseases
Vascular Diseases processed this record on November 20, 2014