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

NCT ID: NCT02326870

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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The AutoLap system

Use of the AutoLap system for controlling the laparoscope during the procedure

Group Type EXPERIMENTAL

AutoLap

Intervention Type DEVICE

Interventions

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AutoLap

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.S.T. Medical Surgery Technology LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivo A. M. J. Broeders, MD

Role: PRINCIPAL_INVESTIGATOR

Meander Medisch Centrum

Locations

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Assuta Medical Center

Haifa, , Israel

Site Status

Assuta Medical Center

Tel Aviv, , Israel

Site Status

Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Israel Netherlands

Other Identifiers

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AL-65-003

Identifier Type: -

Identifier Source: org_study_id

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