Uterine Bleeding DisordersNCT01752725
Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH)
A study testing BiCision® and Ultracision® Har-monic Scalpel(Ethicon) in people with Uterine Bleeding Disorders and Benign Uterine Conditions, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Bleeding Disorders, Benign Uterine Conditions, Focus: Comparison of Two Instruments
- What is being tested?
- BiCision® and Ultracision® Har-monic Scalpel(Ethicon)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH): A Prospective, Controlled, Randomized, Non-inferiority in Vivo Human Study.
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).
- Conditions
- Uterine Bleeding Disorders, Benign Uterine Conditions, Focus: Comparison of Two Instruments
- Being tested
- BiCision®, Ultracision® Har-monic Scalpel(Ethicon)
- Keywords
- supracervical hysterectomy, vessel sealing, bipolar electrocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiCision®Device
Ultracision® Har-monic Scalpel(Ethicon)Device
| Study group | Role | What they receive |
|---|---|---|
| BiCision Arm | Experimental | Coagulation with BiCision Receives: Device: BiCision® |
| Ultracision Arm | Active comparator | Coagulation with Ultracision Receives: Device: Ultracision® Har-monic Scalpel(Ethicon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of hospital stay, an expexted average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Bleeding DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Responsible party
- Principal investigator, Bernhard Kraemer, University Hospital Tuebingen
- Investigators
- Diethelm Wallwiener, Professor, Study chair, University Hospital TuebingenBernhard Krämer, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752725
- Sponsor's protocol ID
- 04122012
- Status last verified
- Dec 2012
- First submitted
- 4 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH): A Prospective, Controlled, Randomized, Non-inferiority in Vivo Human Study.
- ClinicalTrials.gov ID
- NCT01752725
- Acronym / sponsor ID
- 04122012
- Conditions
- Uterine Bleeding Disorders, Benign Uterine Conditions, Focus: Comparison of Two Instruments
- Keywords
- supracervical hysterectomy, vessel sealing, bipolar electrocoagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiCision Arm | Experimental | Device: BiCision®Coagulation with BiCision |
| Ultracision Arm | Active comparator | Device: Ultracision® Har-monic Scalpel(Ethicon)Coagulation with Ultracision |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiCision® | Device | BiCision Arm |
| Ultracision® Har-monic Scalpel(Ethicon) | Device | Ultracision Arm |
Primary outcome
Operation time
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diethelm Wallwiener, Professor study chair
University Hospital Tuebingen
Bernhard Krämer, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiCision® and Ultracision® Har-monic Scalpel(Ethicon) in people with Uterine Bleeding Disorders and Benign Uterine Conditions, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: Participants will be followed for the duration of hospital stay, an expexted average of 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2012.