Laparoscopic HepatectomyNCT03678220
Assessment of Augmented Reality in Minimally Invasive Surgery
A study testing LapAR in people with Laparoscopic Hepatectomy and Laparoscopic Liver Thermal Ablation, run by IGI Technologies, Inc. at 1 site in United States.
Trial summary
The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Hepatectomy, Laparoscopic Liver Thermal Ablation
- What is being tested?
- LapAR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Mar 2020
- 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
- Patient is referred for either laparoscopic partial hepatectomy for tumor removal or laparoscopic ablation of liver cancer;
- Patient must be at least 18 years old;
- Patient provides written consent;
- Patient is considered a suitable candidate based on tumor location for using the AR system.
Who cannot join
- Patients with pacemaker or any other ICD(intra-cardiac device) which may interfere with electromagnetic tracking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15260
David Geller, MD, 412-692-2001, gellerda@upmc.edu
About this study
Official title: Clinical Translation of Augmented Reality Visualization for Laparoscopic Surgery
The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.
Read the detailed description
Surgeons use real-time video generated by a laparoscope to visualize the operative field when performing laparoscopic procedures. An inability to see beneath organ surfaces is a limitation of the current visualization technology. Surgeons additionally use laparoscopic ultrasound to see beneath organ surfaces, but also need to mentally correlate the ultrasound image with the video of the operative field. This process is difficult, subjective, and variable with expertise, and discourages the use of ultrasound.
The investigators have developed a method to combine live laparoscopic video and laparoscopic ultrasound images to present fused multimodality images on a single display, eliminating the need for mental image correlation. Specifically, the image fusion method, called laparoscopic augmented reality (LapAR), augments the laparoscopic video with ultrasound data when required by surgeons. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.
- Being tested
- LapAR
- Keywords
- Laparoscopic Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapARDevice
LapAR system will be used for guidance during laparoscopic hepatectomy and laparoscopic liver thermal ablation
| Study group | Role | What they receive |
|---|---|---|
| Patients using LapAR system | Experimental | Not described Receives: Device: LapAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon interview regarding usability
The ease of use of the LapAR system will be evaluated by the surgeon
Measured: post surgery, an expected average of 5 minutes
Procedure time
Time of using the LapAR system for laparoscopic hepatectomy and laparoscopic thermal ablation
Measured: during surgery
Measurement of margin
Obtain from Pathology department or follow-up imaging
Measured: post surgery
Secondary outcomes (1)
System set-up time
Measured: before surgery, an expected average of 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start1 Apr 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HepatectomyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IGI Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), University of Pittsburgh Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678220
- Sponsor's protocol ID
- LAPAR01
- Other IDs
- 2R42CA192504
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Translation of Augmented Reality Visualization for Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03678220
- Acronym / sponsor ID
- LAPAR01
- Keywords
- Laparoscopic Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IGI Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), University of Pittsburgh Medical Center
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 19 Sep 2018 (actual)
- 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 objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.
Detailed description
Surgeons use real-time video generated by a laparoscope to visualize the operative field when performing laparoscopic procedures. An inability to see beneath organ surfaces is a limitation of the current visualization technology. Surgeons additionally use laparoscopic ultrasound to see beneath organ surfaces, but also need to mentally correlate the ultrasound image with the video of the operative field. This process is difficult, subjective, and variable with expertise, and discourages the use of ultrasound.
The investigators have developed a method to combine live laparoscopic video and laparoscopic ultrasound images to present fused multimodality images on a single display, eliminating the need for mental image correlation. Specifically, the image fusion method, called laparoscopic augmented reality (LapAR), augments the laparoscopic video with ultrasound data when required by surgeons. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients using LapAR system | Experimental | Device: LapAR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is referred for either laparoscopic partial hepatectomy for tumor removal or laparoscopic ablation of liver cancer;
- Patient must be at least 18 years old;
- Patient provides written consent;
- Patient is considered a suitable candidate based on tumor location for using the AR system.
Key exclusion criteria (1 listed)
- Patients with pacemaker or any other ICD(intra-cardiac device) which may interfere with electromagnetic tracking
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 |
|---|---|---|
| LapARLapAR system will be used for guidance during laparoscopic hepatectomy and laparoscopic liver thermal ablation | Device | Patients using LapAR system |
Primary outcome
Surgeon interview regarding usability
Time frame: post surgery, an expected average of 5 minutes
The ease of use of the LapAR system will be evaluated by the surgeon
Procedure time
Time frame: during surgery
Time of using the LapAR system for laparoscopic hepatectomy and laparoscopic thermal ablation
Measurement of margin
Time frame: post surgery
Obtain from Pathology department or follow-up imaging
1 secondary outcome
System set-up time
Time frame: before surgery, an expected average of 15 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LapAR in people with Laparoscopic Hepatectomy and Laparoscopic Liver Thermal Ablation, run by IGI Technologies, Inc. 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raj Shekhar, PhD (202-476-1201, raj@igitechnologies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon interview regarding usability (time frame: post surgery, an expected average of 5 minutes). The study lists 3 primary outcomes in all. 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 26 Feb 2019.