- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02326870
Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study
September 15, 2016 updated by: M.S.T. Medical Surgery Technology LTD.
Evaluation of the Follow me Mode of the AutoLap System - a Feasibility Study
The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
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
-
-
-
Haifa, Israel
- Assuta Medical Center
-
Tel Aviv, Israel
- Assuta Medical Center
-
-
-
-
-
Amersfoort, Netherlands, 3800BM
- Meander Medisch Centrum
-
Utrecht, Netherlands
- University Medical Center Utrecht
-
-
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
Exclusion Criteria:
- Pregnancy
- Extensive adhesions that will preclude routine laparoscopic surgical approach.
- American Society of Anesthesiologists' (ASA) classification>2
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
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: The AutoLap system
Use of the AutoLap system for controlling the laparoscope during the procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of successful "Follow Me" movements
Time Frame: during surgery
|
during surgery
|
System set-up time
Time Frame: during surgery
|
during surgery
|
Length of procedure
Time Frame: during surgery
|
during surgery
|
Number of times that the laparoscope was removed for cleaning
Time Frame: during surgery
|
during surgery
|
AutoLap evaluation questionnaire
Time Frame: post surgery
|
post surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
System repositioning
Time Frame: during surgery
|
during surgery
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Surgeon's learning curve for the use of the AutoLap system
Time Frame: post surgery
|
post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ivo A. M. J. Broeders, MD, Meander Medisch Centrum
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
December 1, 2014
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
December 21, 2014
First Submitted That Met QC Criteria
December 24, 2014
First Posted (ESTIMATE)
December 30, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
September 16, 2016
Last Update Submitted That Met QC Criteria
September 15, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
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 Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures
-
Yonsei UniversityCompletedEarly Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal DissectionKorea, Republic of
-
Women's College HospitalTerminatedAmbulatory Gynecological Laparoscopic ProceduresCanada
-
Mahidol UniversityCompletedThe iNPH Patients Scheduled for VP or LP Shunt ProceduresThailand
-
Maastricht University Medical CenterCompletedPatients Scheduled for Epidural AnaesthesiaNetherlands
-
Yonsei UniversityUnknownPatients Scheduled for Brain SurgeryKorea, Republic of
-
Shahid Beheshti University of Medical SciencesUnknownGlaucoma Patients Scheduled for TrabeculectomyIran, Islamic Republic of
-
Sohag UniversityCompletedPain Management in Adult Females in Child Bearing Period Aging From 20 to 45 Years Who Are Scheduled for Elective Cesarean SectionEgypt
-
Instituto Valenciano de Infertilidad, IVI VALENCIACompletedWe Will Retrospectively Assess Our Databases in Our Clinic | Instituto Valenciano de Infertilidad in Valencia (Spain) | Searching for Assisted Reproduction Procedures | IUI Standard IVF/ICSI Cycles and Ovum Donation IVF/ICSI Cycles | Who Were Referred to Our Unit to Cryopreserve Sperm During... and other conditionsSpain
-
M.S.T. Medical Surgery Technology LTD.CompletedPatients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid ResectionIsrael, Netherlands, Italy
-
Liaoning Tumor Hospital & InstituteNot yet recruitingFor Patients With Colorectal Cancer Liver Metastases Who Were Not Able to Curative Surgical Resection.Focused on the Treatment Effect With the Quintuple MethodChina
Clinical Trials on AutoLap
-
M.S.T. Medical Surgery Technology LTD.CompletedGeneral Laparoscopic Surgery Candidate | Bariatric Laparoscopic Surgery CandidateUnited States
-
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