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Feasibility and Usability of LaparoGuard

NCT03503929 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-15

No results posted yet for this study

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

Interventions

DEVICE

LaparoGuard System

Adjunctive safety system for laparoscopic surgery

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • Federal Economic Development Agency for Southern Ontario (FedDev Ontario)

    collaborator OTHER

  • Mariner Endosurgery

    lead INDUSTRY

Principal Investigators

  • Niv Sne, MD · Hamilton Health Sciences Corporation

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-21
Primary Completion
2024-09-30
Completion
2024-10-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503929 on ClinicalTrials.gov