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

M.S.T. Medical Surgery Technology

Status: Completed

Conditions: General Laparoscopic Surgeries

Treatments: Device: AutoLap system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02934542

AL-65-006-P

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Control Group

No Intervention group

Description:

Patients in this group will undergo an elective standard laparoscopic procedure with a designated OR staff to maneuver the laparoscopic camera. The procedures will be performed according to the hospital and OR routine procedure.

AutoLap Group

Experimental group

Description:

Patients in this group will undergo a laparoscopic procedure using the AutoLap system. In this group the surgeon will use the AutoLap system to hold and control the movements of the laparoscopic camera.

Treatment:

Device: AutoLap system