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CompletedNCT01752725Updated Dec 19, 2012

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

An interventional study of BiCision® and Ultracision® Har-monic Scalpel(Ethicon) in Uterine Bleeding Disorders, Benign Uterine Conditions and Focus: Comparison of Two Instruments, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-19.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study summary

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).

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Conditions studied

  • Uterine Bleeding Disorders
  • Benign Uterine Conditions
  • Focus: Comparison of Two Instruments

Keywords

  • supracervical hysterectomy
  • vessel sealing
  • bipolar electrocoagulation
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In context

Uterine Hemorrhage

156 studies on the registry are indexed under Uterine Hemorrhage; 19 are open to participants now.

This study's enrollment of 30 is below the median of 96 across 111 interventional studies indexed under Uterine Hemorrhage.

Browse Uterine Hemorrhage studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    BiCision Arm

    Coagulation with BiCision

    Device: BiCision®

  • Active comparator
    Ultracision Arm

    Coagulation with Ultracision

    Device: Ultracision® Har-monic Scalpel(Ethicon)

Interventions

  • DeviceBiCision®
  • DeviceUltracision® Har-monic Scalpel(Ethicon)
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What researchers measure

Primary outcomes

  1. Operation time

    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.

    Time frame: Participants will be followed for the duration of hospital stay, an expexted average of 8 months

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Study locations

1 site
  • University Hospital
    Tübingen, 72076, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01752725
Lead sponsor
University Hospital Tuebingen
Collaborators
Erbe Elektromedizin GmbH
Responsible party
Bernhard Kraemer (Executive / Investigator, University Hospital Tuebingen) — Principal investigator
First posted
Dec 19, 2012
Start date
Oct 2011
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Dec 19, 2012

Study contacts

Diethelm Wallwiener, Professor
study chair · University Hospital Tuebingen
Bernhard Krämer, MD
principal investigator · University Hospital Tuebingen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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