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OpenTrials
Completed

NCT Number: NCT02934542

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

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.

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Key information

Conditions

General Laparoscopic Surgeries Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meander Medisch Centrum

Amersfoort, 3800BM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 18 years
  • Able to provide a written informed consent

Exclusion criteria

  • Pregnancy
  • Obesity (BMI >35 Kg/m2)
  • Contra-indications for performing laparoscopy

Treatment and study plan

AutoLap system

Device

Primary outcomes

  1. Success rate in performing an operation with at least one OR person less

    Time frame: During surgery

Secondary outcomes

  1. Duration of the operation

    Time frame: During surgery

  2. Number of times the laparoscope is removed for cleaning

    Time frame: During surgery

  3. Usability evaluation

    Time frame: Up to two days post surgery

Sponsors and collaborators

Lead sponsor

M.S.T. Medical Surgery Technology LTD.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2016
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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