Feasibility and Usability of LaparoGuard

NCT ID: NCT03503929

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-21

Study Completion Date

2024-10-30

Brief Summary

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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

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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

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Laparoscopic Surgical Procedures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label, prospective, single site, multi-investigator
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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LaparoGuard System

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.

Group Type OTHER

LaparoGuard System

Intervention Type DEVICE

Adjunctive safety system for laparoscopic surgery

Interventions

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LaparoGuard System

Adjunctive safety system for laparoscopic surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

Federal Economic Development Agency for Southern Ontario (FedDev Ontario)

OTHER

Sponsor Role collaborator

Mariner Endosurgery

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niv Sne, MD

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

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Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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LAP-PRO-001

Identifier Type: -

Identifier Source: org_study_id

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