Evaluation of the Follow me mode of the AutoLap system- a feasibility study

Evaluation of the Follow me mode of the AutoLap system- a feasibility study - Evaluation of the Follow me mode of the AutoLap system- a feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40655

Enrollment

Registered

2014-11-17

Start date

2014-11-17

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

as mentioned in C21

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Signed and dated Informed Consent Form 2. Patients over 18 years who were scheduled for elective laparoscopic cholecystectomy fundopllication surgery, right hemicolectomy, diaphragmatic hernia, laparoscopic adnexal surgery, excision of endometriosis lesion and diagnostic laparoscopy procedures.

Exclusion criteria

Exclusion criteria: 1.Pregnancy 2.Extensive adhesions that will preclude routine laparoscopic surgical approach. 3.American Society of Anesthesiologist'classification >2

Design outcomes

Primary

Measure	Time frame
Primary endpoints: 1)Number of successful Follow Me movements, which are measured as the ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position using Follow Me mode (see paragraph 10.1). A successful procedure is a considered as a procedure that was completed with the AutoLap system. 2)System set-up time - defined as the time required from covering the AutoLap system with the sterile drape until the CU is registered and the laparoscope camera is connected in the desired position for starting the procedure (the readiness of the AutoLap for use) 3)Length of procedure- Defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed) 4)Number of times that the laparoscope was removed for cleaning 5)AutoLap evaluation questionnaire The ease of use of the AutoLap system and the surgeon*s satisfaction from the AutoLap system will be evaluated by a questionnaire that will be filled by each surgeon after each procedure.	—

Measure

Time frame

Primary endpoints: 1)Number of successful *Follow Me* movements, which are measured as the ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position using Follow Me mode (see paragraph *10.1). A successful procedure is a considered as a procedure that was completed with the AutoLap system. 2)System set-up time - defined as the time required from covering the AutoLap system with the sterile drape until the CU is registered and the laparoscope camera is connected in the desired position for starting the procedure (the readiness of the AutoLap for use) 3)Length of procedure- Defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed) 4)Number of times that the laparoscope was removed for cleaning 5)AutoLap evaluation questionnaire * The ease of use of the AutoLap system and the surgeon*s satisfaction from the AutoLap system will be evaluated by a questionnaire that will be filled by each surgeon after each procedure.

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Secondary

Measure	Time frame
Secondary endpoints: 1)System repositioning: Number of times that the system was repositioned after the initial positioning along the bed rail. Initial positioning is completed once the surgeon starts the procedure. Additional assessment Surgeons learning curve for the use of the AutoLap system will be evaluated based on the following parameters: Number of successful movements Number of required systems repositioning *System set-up time.	—

Measure

Time frame

Secondary endpoints: 1)System repositioning: Number of times that the system was repositioned after the initial positioning along the bed rail. Initial positioning is completed once the surgeon starts the procedure. Additional assessment Surgeon*s learning curve for the use of the AutoLap system will be evaluated based on the following parameters: *Number of successful movements *Number of required system*s repositioning *System set-up time.

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Countries

Netherlands

Outcome results