- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02346552
Usability and Performance Evaluation of the AutoLap System - a Feasibility Study
August 27, 2018 updated by: M.S.T. Medical Surgery Technology LTD.
The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Burlington, Massachusetts, United States, 01805
- Lahey Hospital & Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed and dated Informed Consent Form (ICF).
- Patients over 18 years who were scheduled for elective laparoscopic Cholecystectomy, Nissen fundoplication, paraesophageal hernia and sleeve surgery procedures
Exclusion Criteria:
- Extensive adhesions that will preclude routine laparoscopic surgical approach.
- Pregnancy
- Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Procedures will be performed with the AutoLpap system used for holding and controlling the movement of the laparoscope.
|
|
No Intervention: Group 2
Procedures will be performed with the assistance of human camera holder.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Image stability
Time Frame: during surgery, an expected average of 1 hour
|
measured by the vibrations of inertial sensors
|
during surgery, an expected average of 1 hour
|
Usability
Time Frame: post surgery, an expected average of 3 minutes
|
The ease of use of the AutoLap system will be evaluated by a set of questionnaires
|
post surgery, an expected average of 3 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
System set-up time
Time Frame: during surgery, an expected average of 5 minutes
|
during surgery, an expected average of 5 minutes
|
Length of surgery
Time Frame: during surgery, an expected average of 1 hour
|
during surgery, an expected average of 1 hour
|
The Number of times that the laparoscope was removed for cleaning
Time Frame: during surgery, an expected average of 1 hour
|
during surgery, an expected average of 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dmitry Nepomnayshy, MD, Lahey Hospital & Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
January 8, 2015
First Submitted That Met QC Criteria
January 20, 2015
First Posted (Estimate)
January 27, 2015
Study Record Updates
Last Update Posted (Actual)
August 29, 2018
Last Update Submitted That Met QC Criteria
August 27, 2018
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AL-65-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on General Laparoscopic Surgery Candidate
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompletedObesity, Morbid | Bariatric Surgery Candidate | Laparoscopic Sleeve Gastrectomy
-
The Cleveland ClinicCompletedLaparoscopic Surgery | Surgery | General Anesthesia | PostoperativeUnited States
-
Unidad Internacional de Cirugia Bariatrica y MetabolicaRecruiting
-
Sefako Makgatho Health Sciences UniversityCompletedLaparoscopic Surgery | Laparoscopic Entry Technique
-
Case Comprehensive Cancer CenterCompletedLaparoscopic Surgery | Vaginal SurgeryUnited States
-
Université de SherbrookeCompletedLaparoscopic Surgery | Anesthesia, GeneralCanada
-
L. van HogezandRijnstate HospitalNot yet recruitingBariatric Surgery Candidate
-
University Hospital, Clermont-FerrandRecruitingBariatric Surgery CandidateFrance
-
Tanta UniversityNot yet recruitingBariatric Surgery Candidate
-
Intuitive SurgicalActive, not recruiting
Clinical Trials on AutoLap
-
M.S.T. Medical Surgery Technology LTD.CompletedPatients Who Were Scheduled for General and Gynecological Laparoscopic ProceduresNetherlands, Israel
-
M.S.T. Medical Surgery Technology LTD.CompletedPatients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid ResectionIsrael, Netherlands, Italy
-
M.S.T. Medical Surgery Technology LTD.CompletedGeneral Laparoscopic SurgeriesNetherlands