Evaluation of the Follow Me Mode of the AutoLap System -... | NCT02326870

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

NCT02326870

Sponsor

M.S.T. Medical Surgery Technology LTD.

Status

Completed

Last Update Posted

Sep 16, 2016Estimated

Enrollment

33Actual

Phase

Not Applicable

Conditions

Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures

Interventions

AutoLap

Countries

Israel
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Dec 21, 2014

First Submission Date that Met QC Criteria

Dec 24, 2014

First Posted Date

Dec 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2016

Last Update Posted Date

Sep 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Conditions Module

Conditions

Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures

Keywords

laparoscopic Cholecystectomy
laparoscope holder
gynecological laparoscopy procedures
fundoplication surgery
laparoscopic adnexal surgery
excision of endometriosis lesion
diagnostic laparoscopy procedures
right hemicolectomy
Diaphragmatic hernia

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The AutoLap system	Experimental	Use of the AutoLap system for controlling the laparoscope during the procedure	Device: AutoLap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AutoLap	Device		The AutoLap system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of successful "Follow Me" movements		during surgery
System set-up time		during surgery
Length of procedure		during surgery
Number of times that the laparoscope was removed for cleaning		during surgery
AutoLap evaluation questionnaire		post surgery

Secondary Outcomes

Measure	Description	Time Frame
System repositioning		during surgery

Other Outcomes

Measure	Description	Time Frame
Surgeon's learning curve for the use of the AutoLap system		post surgery

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ivo A. M. J. Broeders, MD	Meander Medisch Centrum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assuta Medical Center		Haifa			Israel
Assuta Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D006548	Hernia, Diaphragmatic

Ancestor Terms

ID	Term
D000082122	Internal Hernia
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided