Minimally Invasive Surgical ProcedureNCT02008409
Evaluation of Safety and Efficacy of the EndoLift Liver Retractor
A study testing EndoLift Liver Retractor in people with Minimally Invasive Surgical Procedure and Laparoscopic Gastric Banding, run by Duke University at 1 site in United States.
Trial summary
The primary goal of the study is to evaluate the safety of the EndoLift Liver Retractor as an internal laparoscopic liver retraction device. The secondary goals of the study are to evaluate the efficacy of the EndoLift Liver Retractor as an internal laparoscopic liver retraction device and to identify 'best practices'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimally Invasive Surgical Procedure, Laparoscopic Gastric Banding, Laparoscopic Roux-en-Y Gastric Bypass
- What is being tested?
- EndoLift Liver Retractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Feb 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible for this clinical study must fulfill all of the following:
- Subject is 18 years of age or older.
- Subject is scheduled for a MIS procedure:
- Laparoscopic Gastric Banding
- Laparoscopic Roux-en-Y Gastric Bypass
- Laparoscopic Sleeve Gastrectomy
Show all 11Show fewer
- Laparoscopic Fundoplication Procedure (Nissen, Toupet, Dor, etc.)
- Laparoscopic Heller myotomy
- Laparoscopic paraesophageal hernia repair
- Laparoscopic gastric resection
- Subject is able to comprehend and give informed consent for participation in this study.
Who cannot join
- Subjects not eligible for this research study include those that have any of the following:
- Subject is unable to comprehend and give informed consent for participation in this study.
- Subject who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Regional Hospital
Durham, North Carolina, 27710
About this study
Official title: Evaluation of Safety and Efficacy of the EndoLift Liver Retractor: a Pilot Study of a New Internal Laparoscopic Liver Retraction Device
The primary goal of the study is to evaluate the safety of the EndoLift Liver Retractor as an internal laparoscopic liver retraction device. The secondary goals of the study are to evaluate the efficacy of the EndoLift Liver Retractor as an internal laparoscopic liver retraction device and to identify 'best practices' for device utilization.
This study evaluates the use of a specific type of liver retractor (EndoLift). Liver retractors are often necessary during MIS procedures, but this retractor is the only device which is deployed internally (NOT requiring additional skin punctures/incisions for placement of the liver retractor device). All patients undergoing minimally invasive surgery (MIS) at Duke Regional Hospital will be approached.
The new device is expected to have a minimal risk safety profile. The investigators believe that these risks are no more than would be encountered by using any other commercially available retraction device available on the market today. Data will be collected and analyzed by the identified investigators. Continuous variables will be analyzed via T-test and Chi-square analysis will be applied to discontinuous variables. Statistical analysis software such as SPSS® will be utilized when necessary.
Read the detailed description
Since the introduction of minimally invasive surgery (MIS) techniques in the 1980's laparoscopic surgery has become the preferred approach for a number of intra-abdominal procedures such as cholecystectomy, gastric bypass, etc.[1] One of the key components of laparoscopic surgery, of any surgery for that matter, is the ability to achieve and maintain adequate visualization of the surgical target throughout the procedure. During certain MIS procedures the patient's internal organs, such as the liver, can block or obscure the surgical view. A number of surgical instruments (retractors) have been developed to help retract abdominal organs "out of the way" during MIS procedures, but all of these devices require an additional abdominal wall puncture/incision to adequately position the device.
Virtual Ports, Ltd. has developed a new laparoscopic liver retractor device, the EndoLift Liver Retractor. This new device does not require additional skin incisions and is placed internally (inside the abdomen) during laparoscopic surgery. The device has 2 ends that "grab" tissue. The body of the device is a smooth, cylindrical steel bar that has minimal risk of traumatizing tissues/organs. The ends of the device are positioned on to peritoneal surfaces (e.g., anterior abdominal wall and/or the right crus of the diaphragm) and the body of the device (smooth cylindrical bar) "pushes" the liver away from the surgical field.
- Conditions
- Minimally Invasive Surgical Procedure, Laparoscopic Gastric Banding, Laparoscopic Roux-en-Y Gastric Bypass, Laparoscopic Sleeve Gastrectomy, Laparoscopic Fundoplication Procedure, Laparoscopic Heller Myotomy
- Being tested
- EndoLift Liver Retractor
- Keywords
- Minimally Invasive Surgery, EndoLift Liver Retractor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoLift Liver RetractorDevice
During the surgery, the surgeon will use the new internal liver retractor device. The device will retract the liver out of the way and help the surgeon see better during the surgery. The device is placed inside the abdomen during the surgery. It is "clipped" onto 2 safe surfaces inside the abdomen. The device is removed before the surgery ends.
| Study group | Role | What they receive |
|---|---|---|
| EndoLift Liver Retractor | Experimental | During surgery, the surgeon will use the new internal liver retractor device. The device will retract the subject's liver out of the way and help the surgeon see better during the surgery. The device is placed inside the abdomen during the surgery. It is "clipped" onto 2 safe surfaces inside the abdomen. The device is removed before the surgery ends. Receives: Device: EndoLift Liver Retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The primary study endpoint will be to establish the safety of using the EndoLift Liver Retractor as an internal laparoscopic liver retraction device.
Safety will be established by lack of serious events. Events are defined as adverse if they require change in the operative course, a device specific complication and/or association with prolongation of hospital stay.
Measured: Day 1 post-op
Secondary outcomes (1)
Effective use of the EndoLift Liver Retractor
The effective use of the EndoLift Liver Retractor as a liver retraction device during surgery will be considered a "success". If there is a need to use any additional equipment to retract the liver during the surgery, the subject will be scored a "failure".
Study success will be declared if at least 80% of subjects are scored a "success".
Measured: Up to 6 hours during the operative procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: The study was terminated. Six subjects were consented \& all were withdrawn before any study activities took place.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Virtual Ports
- Responsible party
- Sponsor
- Investigators
- Dana Portenier, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008409
- Sponsor's protocol ID
- Pro00028255
- Status last verified
- Aug 2015
- First submitted
- 22 Nov 2013
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the EndoLift Liver Retractor: a Pilot Study of a New Internal Laparoscopic Liver Retraction Device
- ClinicalTrials.gov ID
- NCT02008409
- Acronym / sponsor ID
- Pro00028255
- Conditions
- Minimally Invasive Surgical Procedure, Laparoscopic Gastric Banding, Laparoscopic Roux-en-Y Gastric Bypass, Laparoscopic Sleeve Gastrectomy, Laparoscopic Fundoplication Procedure, Laparoscopic Heller Myotomy
- Keywords
- Minimally Invasive Surgery, EndoLift Liver Retractor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated. Six subjects were consented \& all were withdrawn before any study activities took place.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Virtual Ports
- Study start
- Nov 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Dec 2013 (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 primary goal of the study is to evaluate the safety of the EndoLift Liver Retractor as an internal laparoscopic liver retraction device. The secondary goals of the study are to evaluate the efficacy of the EndoLift Liver Retractor as an internal laparoscopic liver retraction device and to identify 'best practices' for device utilization.
This study evaluates the use of a specific type of liver retractor (EndoLift). Liver retractors are often necessary during MIS procedures, but this retractor is the only device which is deployed internally (NOT requiring additional skin punctures/incisions for placement of the liver retractor device). All patients undergoing minimally invasive surgery (MIS) at Duke Regional Hospital will be approached.
The new device is expected to have a minimal risk safety profile. The investigators believe that these risks are no more than would be encountered by using any other commercially available retraction device available on the market today. Data will be collected and analyzed by the identified investigators. Continuous variables will be analyzed via T-test and Chi-square analysis will be applied to discontinuous variables. Statistical analysis software such as SPSS® will be utilized when necessary.
Detailed description
Since the introduction of minimally invasive surgery (MIS) techniques in the 1980's laparoscopic surgery has become the preferred approach for a number of intra-abdominal procedures such as cholecystectomy, gastric bypass, etc.[1] One of the key components of laparoscopic surgery, of any surgery for that matter, is the ability to achieve and maintain adequate visualization of the surgical target throughout the procedure. During certain MIS procedures the patient's internal organs, such as the liver, can block or obscure the surgical view. A number of surgical instruments (retractors) have been developed to help retract abdominal organs "out of the way" during MIS procedures, but all of these devices require an additional abdominal wall puncture/incision to adequately position the device.
Virtual Ports, Ltd. has developed a new laparoscopic liver retractor device, the EndoLift Liver Retractor. This new device does not require additional skin incisions and is placed internally (inside the abdomen) during laparoscopic surgery. The device has 2 ends that "grab" tissue. The body of the device is a smooth, cylindrical steel bar that has minimal risk of traumatizing tissues/organs. The ends of the device are positioned on to peritoneal surfaces (e.g., anterior abdominal wall and/or the right crus of the diaphragm) and the body of the device (smooth cylindrical bar) "pushes" the liver away from the surgical field.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoLift Liver Retractor | Experimental | Device: EndoLift Liver RetractorDuring surgery, the surgeon will use the new internal liver retractor device. The device will retract the subject's liver out of the way and help the surgeon see better during the surgery. The device is placed inside the abdomen during the surgery. It is "clipped" onto 2 safe surfaces inside the abdomen. The device is removed before the surgery ends. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is 18 years of age or older.
- Subject is scheduled for a MIS procedure:
- Subject is able to comprehend and give informed consent for participation in this study.
Key exclusion criteria (3 listed)
- Subjects not eligible for this research study include those that have any of the following:
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 |
|---|---|---|
| EndoLift Liver RetractorDuring the surgery, the surgeon will use the new internal liver retractor device. The device will retract the liver out of the way and help the surgeon see better during the surgery. The device is placed inside the abdomen during the surgery. It is "clipped" onto 2 safe surfaces inside the abdomen. The device is removed before the surgery ends. | Device | EndoLift Liver Retractor |
Primary outcome
Safety
Time frame: Day 1 post-op
The primary study endpoint will be to establish the safety of using the EndoLift Liver Retractor as an internal laparoscopic liver retraction device. Safety will be established by lack of serious events. Events are defined as adverse if they require change in the operative course, a device specific complication and/or association with prolongation of hospital stay.
1 secondary outcome
Effective use of the EndoLift Liver Retractor
Time frame: Up to 6 hours during the operative procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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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.
Dana Portenier, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoLift Liver Retractor in people with Minimally Invasive Surgical Procedure and Laparoscopic Gastric Banding, run by Duke University at 1 site 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 11 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 Aug 2015. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety (time frame: Day 1 post-op). 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 5 Aug 2015.