Feasibility and Usability of LaparoGuard

NCT03503929 | Unknown

• 1 other identifier: LAP-PRO-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pre-operative LaparoGuard system setup time

  Baseline

• Usability reported pre-operatively by nurses

  Baseline

• Safe zone deviations

  Intraoperative

• Usability reported post-operatively by surgical team

  Intraoperative

• Clinical utility reported by expert surgeons

  2 months

Study Arms (1)

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.

Device: LaparoGuard System

Interventions

LaparoGuard System DEVICE

Adjunctive safety system for laparoscopic surgery

LaparoGuard System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mariner Endosurgery: lead
• Hamilton Health Sciences Corporation: collaborator
• Federal Economic Development Agency for Southern Ontario (FedDev Ontario): collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Study Officials

• Niv Sne, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, prospective, single site, multi-investigator

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: April 20, 2018
• Study Start: June 21, 2019
• Primary Completion: September 30, 2024
• Study Completion: October 30, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)