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.Study Procedures: No. & type. A total of 35 laparoscopic…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gallbladder disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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.
Background summary
Evaluation of the Follow me mode of the AutoLap system * a feasibility study.
Study objective
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.
Study Procedures: No. & type. A total of 35 laparoscopic procedures will be
performed in the study, in up to 4 centers in Europe and Israel. Procedure
types include:
Cholecystectomy, fundoplication surgery, right hemicolectomy, Diaphragmatic
hernia, laparoscopic adnexal surgery, excision of
endometriosis lesion and diagnostic laparoscopy procedures.
Study design
Study Design:Prospective, multi-center study, one arm, open label.
Intervention
not applicable
Study burden and risks
Minimal / theoretical: damage to internal organs due to unexpected or rude
movements of the endoscope.
Kochav Yokneam Floor 5
Yokneam 20692
IL
Kochav Yokneam Floor 5
Yokneam 20692
IL
Listed location countries
Age
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
1.Pregnancy
2.Extensive adhesions that will preclude routine laparoscopic surgical approach.
3.American Society of Anesthesiologist'classification >2
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50856.100.14 |