Laparoscopic Surgical ProceduresNCT03503929
Feasibility and Usability of LaparoGuard
A study testing LaparoGuard System in people with Laparoscopic Surgical Procedures, run by Mariner Endosurgery at 1 site in Canada.
Trial summary
LaparoGuard is intended as an adjunctive safety system for laparoscopic surgery. The system allows surgeons to virtually annotate a safe anatomical volume inside the body cavity of the patient during a laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgical Procedures
- What is being tested?
- LaparoGuard System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jun 2019to 30 Oct 2024
- 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
- Patients undergoing routine laparoscopic procedures. Examples include (non-exhaustive): operative laparoscopy, appendectomy, cholecystectomy, colon resection, inguinal or diaphragmatic hernia repairs.
- Ability to read and understand English
- Consent to use of the LaparoGuard system in their procedure (18 yrs or older)
Who cannot join
- Unwilling to sign informed consent
- Simple diagnostic laparoscopy (can be included if conversion to operative laparoscopy)
- Surgeries which require conversion to laparotomy for patient safety reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Feasibility and Usability of the LaparoGuard System During Laparoscopic Surgical Procedures
LaparoGuard is intended as an adjunctive safety system for laparoscopic surgery. The system allows surgeons to virtually annotate a safe anatomical volume inside the body cavity of the patient during a laparoscopic surgery. The surgeon then receives notification throughout the procedure whenever a tracked rigid instrument has exited that volume. This open label, prospective, feasibility, single site, multi-investigator trial will evaluate the feasibility and usability of the LaparoGuard system during laparoscopic surgical procedures.
Read the detailed description
PHASE 1) LaparoGuard will be used as an adjunctive tool for maintaining safety during procedures performed by expert surgeons. The pre-operative instructions for use will be evaluated along with ease of procedural setup, as reported by pre-operative nurses. The intraoperative instructions for use will be evaluated along with system usability, as reported by the expert surgeons. The perceived clinical utility will be judged by expert surgeons. Postoperatively, the system data will be reviewed. This phase will include 4-6 subjects.
PHASE 2) Novice surgeons will conduct procedures alongside expert surgeons. Expert surgeons will establish the safe zone. LaparoGuard will record all deviations, speed and smoothness of tip movements. The training utility of LaparoGuard will be assessed by both the expert and novice surgeons. This phase will include 4-6 subjects.
- Conditions
- Laparoscopic Surgical Procedures
- Being tested
- LaparoGuard System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoGuard SystemDevice
Adjunctive safety system for laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| LaparoGuard System | Other | All patients receiving laparoscopic surgery, candidates for prolonged time under anesthesia, and are admitted for gynecological, urological or general surgery procedures who consent to use of the LaparoGuard System. Receives: Device: LaparoGuard System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
For each surgical procedure conducted, the case will be defined as a technical success if: the surgical team is able to complete the procedure without needing to turn off the LaparoGuard system. Failure will be if the operator deems it necessary to stop utilizing the LaparoGuard system and resort to the standard (non-annotated) endoscopic camera feed. Potential reasons for doing so may be device reporting errors, such as the LaparoGuard system consistently incorrectly reporting that a surgical tool has exited the safe zone.
In emergency situations, such as changes in medical condition unrelated to use of the LaparoGuard system, the operator may also deem it necessary to resort to the standard-of-care; however, these situations will not be judged as failures and the case data will be utilized for study purposes up until that point.
Measured: Intraoperative
Secondary outcomes (6)
Pre-operative LaparoGuard system setup time
The amount of time taken to setup the LaparoGuard system by the surgical nurses will be recorded
Measured: Baseline
Usability reported pre-operatively by nurses
Following setup of the LaparoGuard system preoperatively, but prior to bringing the patient into the surgical suite, study staff will conduct a short interview with the surgical nurses to evaluate their comfort and ease with the system setup procedures. If any use errors or confusion were observed by the study staff, these shall be discussed in depth. Comments reported by the nurses on difficulties encountered and potential simplifications to the procedures will be recorded.
Measured: Baseline
Safe zone deviations
The total number of safe zone deviations as well the total time each instrument was outside the safe zone will be tracked and evaluated.
Measured: Intraoperative
Usability reported post-operatively by surgical team
Following completion of each surgical procedure, study staff will conduct a short interview with the surgical team to evaluate the ability of the team to interpret the LaparoGuard output, the safe zone and respond to any information provided by system.
Measured: Intraoperative
Clinical utility reported by expert surgeons
Following the completion of all 10 cases, study staff will conduct interviews with the expert surgeons to evaluate their perceived clinical utility of the LaparoGuard system. A qualitative discussion will held around the particular clinical situations in which LaparoGuard may be most useful. Study staff will also record any potential insights by the surgeons on future features which may be incorporated to improve the clinical utility of LaparoGuard.
Measured: 2 months
Training utility reported by novice and expert surgeons
Following the completion of all 10 cases, study staff will conduct interviews with the expert and novice surgeons to evaluate their perceived training utility of the LaparoGuard system. Quantitative rating scales will be used and qualitative discussion will held around the particular training situations in which LaparoGuard may be most useful. Study staff will also record any potential insights by the expert or novice surgeons on future features which may be incorporated to improve the training utility of LaparoGuard.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start21 Jun 2019
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Surgical ProceduresStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, prospective, single site, multi-investigator
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mariner Endosurgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hamilton Health Sciences Corporation, Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
- Responsible party
- Sponsor
- Investigators
- Niv Sne, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503929
- Sponsor's protocol ID
- LAP-PRO-001
- Status last verified
- Mar 2023
- First submitted
- 25 Jan 2018
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Feasibility and Usability of the LaparoGuard System During Laparoscopic Surgical Procedures
- ClinicalTrials.gov ID
- NCT03503929
- Acronym / sponsor ID
- LAP-PRO-001
- Conditions
- Laparoscopic Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mariner EndosurgeryIndustry (pharma, biotech, devices)
- Collaborators
- Hamilton Health Sciences Corporation, Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 20 Apr 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.
LaparoGuard is intended as an adjunctive safety system for laparoscopic surgery. The system allows surgeons to virtually annotate a safe anatomical volume inside the body cavity of the patient during a laparoscopic surgery. The surgeon then receives notification throughout the procedure whenever a tracked rigid instrument has exited that volume. This open label, prospective, feasibility, single site, multi-investigator trial will evaluate the feasibility and usability of the LaparoGuard system during laparoscopic surgical procedures.
Detailed description
PHASE 1) LaparoGuard will be used as an adjunctive tool for maintaining safety during procedures performed by expert surgeons. The pre-operative instructions for use will be evaluated along with ease of procedural setup, as reported by pre-operative nurses. The intraoperative instructions for use will be evaluated along with system usability, as reported by the expert surgeons. The perceived clinical utility will be judged by expert surgeons. Postoperatively, the system data will be reviewed. This phase will include 4-6 subjects.
PHASE 2) Novice surgeons will conduct procedures alongside expert surgeons. Expert surgeons will establish the safe zone. LaparoGuard will record all deviations, speed and smoothness of tip movements. The training utility of LaparoGuard will be assessed by both the expert and novice surgeons. This phase will include 4-6 subjects.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, prospective, single site, multi-investigator
| Arm | Type | Receives |
|---|---|---|
| LaparoGuard System | Other | Device: LaparoGuard SystemAll patients receiving laparoscopic surgery, candidates for prolonged time under anesthesia, and are admitted for gynecological, urological or general surgery procedures who consent to use of the LaparoGuard System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing routine laparoscopic procedures. Examples include (non-exhaustive): operative laparoscopy, appendectomy, cholecystectomy, colon resection, inguinal or diaphragmatic hernia repairs.
- Ability to read and understand English
- Consent to use of the LaparoGuard system in their procedure (18 yrs or older)
Key exclusion criteria (3 listed)
- Unwilling to sign informed consent
- Simple diagnostic laparoscopy (can be included if conversion to operative laparoscopy)
- Surgeries which require conversion to laparotomy for patient safety reasons
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 |
|---|---|---|
| LaparoGuard SystemAdjunctive safety system for laparoscopic surgery | Device | LaparoGuard System |
Primary outcome
Procedural Success
Time frame: Intraoperative
For each surgical procedure conducted, the case will be defined as a technical success if: the surgical team is able to complete the procedure without needing to turn off the LaparoGuard system. Failure will be if the operator deems it necessary to stop utilizing the LaparoGuard system and resort to the standard (non-annotated) endoscopic camera feed. Potential reasons for doing so may be device reporting errors, such as the LaparoGuard system consistently incorrectly reporting that a surgical tool has exited the safe zone. In emergency situations, such as changes in medical condition unrelated to use of the LaparoGuard system, the operator may also deem it necessary to resort to the standard-of-care; however, these situations will not be judged as failures and the case data will be utilized for study purposes up until that point.
6 secondary outcomes
Pre-operative LaparoGuard system setup time
Time frame: Baseline
Usability reported pre-operatively by nurses
Time frame: Baseline
Safe zone deviations
Time frame: Intraoperative
Usability reported post-operatively by surgical team
Time frame: Intraoperative
Clinical utility reported by expert surgeons
Time frame: 2 months
Training utility reported by novice and expert surgeons
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Niv Sne, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LaparoGuard System in people with Laparoscopic Surgical Procedures, run by Mariner Endosurgery at 1 site in Canada.
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 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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 Canada. 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?
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?
Procedural Success (time frame: Intraoperative). 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 15 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.