Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder

Not Applicable

Completed

• Conditions: General Laparoscopic Surgeries

• Registration Number: NCT02934542
• Lead Sponsor: M.S.T. Medical Surgery Technology LTD.

Brief Summary

The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the AutoLap system compared with the standard operation.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Status Verified: 2017-09
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Aged ≥ 18 years
2. Able to provide a written informed consent

Exclusion Criteria

1. Pregnancy
2. Obesity (BMI >35 Kg/m2)
3. Contra-indications for performing laparoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Success rate in performing an operation with at least one OR person less	During surgery

Secondary Outcome Measures

Name	Time	Method
Duration of the operation	During surgery
Usability evaluation	Up to two days post surgery
Number of times the laparoscope is removed for cleaning	During surgery

Trial Locations

Locations (1)

Meander Medisch Centrum; 🇳🇱 Amersfoort, Netherlands