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

Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH): A Prospective, Controlled, Randomized, Non-inferiority in Vivo Human Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01752725

Enrollment

Registered

2012-12-19

Start date

2011-10-31

Completion date

2012-04-30

Last updated

2012-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

supracervical hysterectomy, vessel sealing, bipolar electrocoagulation

Brief 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).

Interventions

DEVICEBiCision®

DEVICEUltracision® Har-monic Scalpel(Ethicon)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Operation time	Participants will be followed for the duration of hospital stay, an expexted average of 8 months	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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026