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

This study has been completed.
Sponsor:
Collaborator:
ERBE Elektromedizin GmbH
Information provided by (Responsible Party):
Bernhard Kraemer, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01752725
First received: December 4, 2012
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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)

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752725

Locations
Germany
University Hospital
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
ERBE Elektromedizin GmbH
Investigators
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
ClinicalTrials.gov 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
Hemorrhagic Disorders
Hemorrhage
Uterine Hemorrhage
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013