Clinical trial NCT03503929: Feasibility and Usability of LaparoGuard
Official title: A Pilot Study Evaluating the Feasibility and Usability of the LaparoGuard System During Laparoscopic Surgical Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Surgical Procedures
Lead sponsor: Mariner Endosurgery
Sponsor class: INDUSTRY
Collaborators: name: Hamilton Health Sciences Corporation
name: Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
First posted: 2018-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, prospective, single site, multi-investigator
Primary purpose: DEVICE_FEASIBILITY

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedural Success
timeFrame: Intraoperative
Secondary outcomes:
measure: Pre-operative LaparoGuard system setup time
timeFrame: Baseline
measure: Usability reported pre-operatively by nurses
timeFrame: Baseline
measure: Safe zone deviations
timeFrame: Intraoperative
measure: Usability reported post-operatively by surgical team
timeFrame: Intraoperative
measure: Clinical utility reported by expert surgeons
timeFrame: 2 months
measure: Training utility reported by novice and expert surgeons
timeFrame: 2 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Niv Sne, MD
role: PRINCIPAL_INVESTIGATOR
References: