Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study

Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures Clinical Trial

Official title:

Evaluation of the Follow me Mode of the AutoLap System - a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326870
• Other study ID #: AL-65-003
• Status: Completed
• Phase: N/A
• First received: December 21, 2014
• Last updated: September 15, 2016
• Start date: December 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: M.S.T. Medical Surgery Technology LTD.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed and dated Informed Consent Form (ICF).

2. Patients over 18 years

Exclusion Criteria:

1. Pregnancy

2. Extensive adhesions that will preclude routine laparoscopic surgical approach.

3. American Society of Anesthesiologists' (ASA) classification>2

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures

Intervention

Device:
• AutoLap

Locations

Country	Name	City	State
Israel	Assuta Medical Center	Haifa
Israel	Assuta Medical Center	Tel Aviv
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
M.S.T. Medical Surgery Technology LTD.

Countries where clinical trial is conducted

Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgeon's learning curve for the use of the AutoLap system		post surgery	No
Primary	Number of successful "Follow Me" movements		during surgery	No
Primary	System set-up time		during surgery	No
Primary	Length of procedure		during surgery	No
Primary	Number of times that the laparoscope was removed for cleaning		during surgery	No
Primary	AutoLap evaluation questionnaire		post surgery	No
Secondary	System repositioning		during surgery	No