Study Results
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-06-21
2024-10-30
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
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.
LaparoGuard System
Adjunctive safety system for laparoscopic surgery
Interventions
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LaparoGuard System
Adjunctive safety system for laparoscopic surgery
Eligibility Criteria
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Inclusion Criteria
* Ability to read and understand English
* Consent to use of the LaparoGuard system in their procedure (18 yrs or older)
Exclusion Criteria
* Simple diagnostic laparoscopy (can be included if conversion to operative laparoscopy)
* Surgeries which require conversion to laparotomy for patient safety reasons
18 Years
ALL
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
OTHER
Mariner Endosurgery
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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LAP-PRO-001
Identifier Type: -
Identifier Source: org_study_id
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