Task PerformanceNCT02163538
Articulating Enseal Versus Ligasure Energy Devices
A study testing articulating Enseal and Ligasure device in people with Task Performance, run by University of Louisville at 2 sites in United States.
Trial summary
This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index) ergonomic assessment tool to detect differences in surgeon workload when using commercially available advanced bipolar devices. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Task Performance
- What is being tested?
- articulating Enseal and Ligasure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Able and willing to provide informed consent
- Undergoing total laparoscopic hysterectomy
Who cannot join
- Under 18 years of age
- Severe endometriosis or adhesions requiring >15min of adhesiolysis prior to beginning hysterectomy
- Unsafe to use energy device due to decreased visualization or any other reason deemed to be unsafe by the surgeon intra-operative decision to convert to laparotomy prior to use of energy device
- Current diagnosis of uterine, tubal ovarian or cervical malignancy.
- Patients who cannot read/understand English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Louisville Health Care Outpatient Center
Louisville, Kentucky, 40202
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
Official title: A Comparison of Industry Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating Enseal Versus Ligasure Energy Devices
This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index) ergonomic assessment tool to detect differences in surgeon workload when using commercially available advanced bipolar devices. It is anticipated that the raw-TLX version of the validated NASA-TLX ergonomic assessment tool will detect less surgeon effort required in the procedure when articulating ENSEAL is utilized. The Articulating ENSEAL device may also positively impact other variables such as blood loss, operative time and cost.
Read the detailed description
This study is a single-center, single-blinded, randomized control, pilot trial that will be conducted at the University of Louisville Hospital. It is designed to assess whether there are different surgical outcomes with regard to surgeon perception of ease of instrument use, operative time, estimated blood loss, cost and perioperative complication rates between the Ethicon Articulating Enseal versus the LigaSure for total laparoscopic hysterectomy. This will be assessed using the raw-TLX version of the validated NASA-TLX scale.
The study will be single-blinded in that the patient will not be informed of their group assignment; it is impossible to blind the surgeon using the devices.
Methods and Procedures:
Patients undergoing total laparoscopic hysterectomy will be recruited from our University of Louisville Health Care Outpatient Center (HCOC) outpatient office and will be consented for participation in the study during their preoperative office visit.
Patients will be randomized pre-operatively on their date of surgery to one of two groups:
Group 1: The articulating Enseal device will be used during the hysterectomy. Group 2: The Ligasure device will be used during the hysterectomy.
All cases will be videotaped for review of operative time and complications; this is standard procedure at our institution.
To evaluate our primary objective, i.e., the potential ergonomic and surgical advantages of an articulating tip in an energy device, the raw-TLX of the validated NASA-TLX scale will be completed by the primary surgeon at the end of each surgery.
Subjects will be seen for study follow-up during their routine post-operative visits at 2 weeks, 6 weeks and within 3 months after surgery in the event of a hospital admission for a surgery-related complication.
No compensation for participation will be offered to patients and no compensation for subject recruitment will be gained by investigators. This will be disclosed during the informed consent process.
Inclusion Criteria:
- Age 18 or older
- Able and willing to provide informed consent
- Undergoing total laparoscopic hysterectomy
Exclusion Criteria:
- Under 18 years of age
- Severe endometriosis or adhesions requiring >15min of adhesiolysis prior to beginning hysterectomy
- Unsafe to use energy device due to decreased visualization or any other reason deemed to be unsafe by the surgeon
- Intra-operative decision to convert to laparotomy prior to use of energy device
- Current diagnosis of uterine, tubal ovarian or cervical malignancy.
- Patients who cannot read/understand English.
- Conditions
- Task Performance
- Being tested
- articulating Enseal, Ligasure device
- Keywords
- energy device, laparoscopic, hysterectomy, enseal, ligasure, raw tlx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
articulating EnsealDevice
Vessel-sealing device used for laparoscopic hysterectomy.
Ligasure deviceDevice
Vessel-sealing device used for laparoscopic hysterectomy.
| Study group | Role | What they receive |
|---|---|---|
| articulating Enseal | Active comparator | This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. Receives: Device: articulating Enseal |
| Ligasure device | Active comparator | This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Receives: Device: Ligasure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raw Task Load Index (TLX) Score Assigned by Surgeons
The Official NASA Task Load Index (TLX) is a subjective workload assessment tool to allow users to perform subjective workload assessments on operator(s) working with various human-machine interface systems. By incorporating a multi-dimensional rating procedure, NASA TLX derives an overall workload score based on a weighted average of ratings on six subscales given below. The overall workload score ranges between 0 and 100 with 100 being the most demanding.
Mental Demand Physical Demand Temporal Demand Performance Effort Frustration
Measured: 18 months
Secondary outcomes (5)
Intra- and Post-operative Complications
Measured: 18 months
Estimated Blood Loss
Measured: 18 months
Need for Second Energy Device Intra-operatively
Measured: 18 months
Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.
Measured: During procedure
Time Required to Complete Procedure
Measured: End of surgery up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Task PerformanceStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Responsible party
- Principal investigator, Resad Pasic, University of Louisville
- Investigators
- Resad Pasic, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163538
- Sponsor's protocol ID
- Energy Devices-UL
- Status last verified
- Nov 2017
- First submitted
- 11 Jun 2014
- Last updated
- 13 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data shared with study sponsor, Ethicon, and will be submitted for journal publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Industry Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating Enseal Versus Ligasure Energy Devices
- ClinicalTrials.gov ID
- NCT02163538
- Acronym / sponsor ID
- Energy Devices-UL
- Conditions
- Task Performance
- Keywords
- energy device, laparoscopic, hysterectomy, enseal, ligasure, raw tlx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Posted 17 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index) ergonomic assessment tool to detect differences in surgeon workload when using commercially available advanced bipolar devices. It is anticipated that the raw-TLX version of the validated NASA-TLX ergonomic assessment tool will detect less surgeon effort required in the procedure when articulating ENSEAL is utilized. The Articulating ENSEAL device may also positively impact other variables such as blood loss, operative time and cost.
Detailed description
This study is a single-center, single-blinded, randomized control, pilot trial that will be conducted at the University of Louisville Hospital. It is designed to assess whether there are different surgical outcomes with regard to surgeon perception of ease of instrument use, operative time, estimated blood loss, cost and perioperative complication rates between the Ethicon Articulating Enseal versus the LigaSure for total laparoscopic hysterectomy. This will be assessed using the raw-TLX version of the validated NASA-TLX scale.
The study will be single-blinded in that the patient will not be informed of their group assignment; it is impossible to blind the surgeon using the devices.
Methods and Procedures:
Patients undergoing total laparoscopic hysterectomy will be recruited from our University of Louisville Health Care Outpatient Center (HCOC) outpatient office and will be consented for participation in the study during their preoperative office visit.
Patients will be randomized pre-operatively on their date of surgery to one of two groups:
Group 1: The articulating Enseal device will be used during the hysterectomy. Group 2: The Ligasure device will be used during the hysterectomy.
All cases will be videotaped for review of operative time and complications; this is standard procedure at our institution.
To evaluate our primary objective, i.e., the potential ergonomic and surgical advantages of an articulating tip in an energy device, the raw-TLX of the validated NASA-TLX scale will be completed by the primary surgeon at the end of each surgery.
Subjects will be seen for study follow-up during their routine post-operative visits at 2 weeks, 6 weeks and within 3 months after surgery in the event of a hospital admission for a surgery-related complication.
No compensation for participation will be offered to patients and no compensation for subject recruitment will be gained by investigators. This will be disclosed during the informed consent process.
Inclusion Criteria:
- Age 18 or older
- Able and willing to provide informed consent
- Undergoing total laparoscopic hysterectomy
Exclusion Criteria:
- Under 18 years of age
- Severe endometriosis or adhesions requiring >15min of adhesiolysis prior to beginning hysterectomy
- Unsafe to use energy device due to decreased visualization or any other reason deemed to be unsafe by the surgeon
- Intra-operative decision to convert to laparotomy prior to use of energy device
- Current diagnosis of uterine, tubal ovarian or cervical malignancy.
- Patients who cannot read/understand English.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| articulating Enseal | Active comparator | Device: articulating EnsealThis group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device. |
| Ligasure device | Active comparator | Device: Ligasure deviceThis group of women undergoing hysterectomy is randomized to the Ligasure energy device. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Able and willing to provide informed consent
- Undergoing total laparoscopic hysterectomy
Key exclusion criteria (5 listed)
- Under 18 years of age
- Severe endometriosis or adhesions requiring >15min of adhesiolysis prior to beginning hysterectomy
- Unsafe to use energy device due to decreased visualization or any other reason deemed to be unsafe by the surgeon intra-operative decision to convert to laparotomy prior to use of energy device
- Current diagnosis of uterine, tubal ovarian or cervical malignancy.
- Patients who cannot read/understand English.
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 |
|---|---|---|
| articulating EnsealVessel-sealing device used for laparoscopic hysterectomy. | Device | articulating Enseal |
| Ligasure deviceVessel-sealing device used for laparoscopic hysterectomy. | Device | Ligasure device |
Primary outcome
Raw Task Load Index (TLX) Score Assigned by Surgeons
Time frame: 18 months
The Official NASA Task Load Index (TLX) is a subjective workload assessment tool to allow users to perform subjective workload assessments on operator(s) working with various human-machine interface systems. By incorporating a multi-dimensional rating procedure, NASA TLX derives an overall workload score based on a weighted average of ratings on six subscales given below. The overall workload score ranges between 0 and 100 with 100 being the most demanding. Mental Demand Physical Demand Temporal Demand Performance Effort Frustration
5 secondary outcomes
Intra- and Post-operative Complications
Time frame: 18 months
Estimated Blood Loss
Time frame: 18 months
Need for Second Energy Device Intra-operatively
Time frame: 18 months
Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.
Time frame: During procedure
Time Required to Complete Procedure
Time frame: End of surgery up to 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data shared with study sponsor, Ethicon, and will be submitted for journal publication.
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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.
Resad Pasic, MD, PhD principal investigator
University of Louisville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing articulating Enseal and Ligasure device in people with Task Performance, run by University of Louisville at 2 sites in United States.
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 3 inclusion and 5 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 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 17 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Raw Task Load Index (TLX) Score Assigned by Surgeons (time frame: 18 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 13 Feb 2018.