Feasibility and Usability of LaparoGuard

Laparoscopic Surgical Procedures Clinical Trial

Official title:

A Pilot Study Evaluating the Feasibility and Usability of the LaparoGuard System During Laparoscopic Surgical Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03503929
• Other study ID #: LAP-PRO-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 21, 2019
• Est. completion date: October 30, 2024

Study information

• Verified date: March 2023
• Source: Mariner Endosurgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: October 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Laparoscopic Surgical Procedures

Intervention

Device:
• LaparoGuard System
Adjunctive safety system for laparoscopic surgery

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Mariner Endosurgery	Federal Economic Development Agency for Southern Ontario (FedDev Ontario), Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intraoperative
Secondary	Pre-operative LaparoGuard system setup time	The amount of time taken to setup the LaparoGuard system by the surgical nurses will be recorded	Baseline
Secondary	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.	Baseline
Secondary	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.	Intraoperative
Secondary	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.	Intraoperative
Secondary	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.	2 months
Secondary	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.	2 months