Assessment of the Wide Field of View Provided by the SurroundScope

Study Overview
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Brief Summary
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The aim of this study is to assess the need and potential benefits of the wide field of view during general and gynecology laparoscopic surgery.

Detailed Description
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The tremendous popularity of the laparoscopic surgeries is balanced with its tradeoffs - the needs for an excellent intracavitary visualization along with a surgeon skill set capable of performing these, often more technically challenging procedures. Image quality has improved, but there are still various restrictions to images captured by the lens at the tip of a long tubular laparoscope. 270Surgical developed a 270 degree angle scope to overcome these unmet needs and improve the image quantity and extent during laparoscopy. The study will evaluate standard laparoscopic surgery using the 270Surgical system; The SurroundScope.

Official Title
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Assessment of the Wide Field of View Provided by the SurroundScope

Conditions
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Laparoscopic Surgery

Intervention / Treatment
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* Device: SurroundScope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 Capable of giving informed consent Scheduled for general or gynecology laparoscopic surgery or open procedure that in the surgeon's opinion can be performed laparoscopically with the 270System Exclusion Criteria: Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator) Patients with contraindications to undergo surgery Patients with ASA class* >3 Advanced cirrhosis with failure of hepatic function Patients who have participated in another interventional clinical study in the last month Pregnancy Unable to consent (due to cultural, language or neurological barriers)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SurroundScope<br>For laparoscopic camera system, the SurroundScope. 270-degree angle videoscope (270Surgical, Israel) was used | Device: SurroundScope<br>* The study will evaluate standard laparoscopic surgery using the 270Surgical system. The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the need and potential benefits of the wide field of view | Assessed by a multi-question subjective questionnaire completed in the OR, immediately after the case, by the surgeon and the camera person and constructed on a Likert-type, 5-point scale (1=Strongly disagree, 2=Disagree, 3=Neither agree or disagree, 4=Agree, 5=Strongly agree). | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the 270 Lenses clearance contribution to the procedure. | Lenses clearance contribution will be assessed by: Rating of the visual impairment due to smoke using a likert-type scale of 1-5: 1=imperceptible, 2= perceptible but not interfering, 3=same as in standard procedure, 4=annoying, 5=Very annoying. | Day of surgery | 
| Assessment of the 270 Lenses clearance contribution to the procedure. | Lenses clearance contribution will be assessed by: Amount of removals and pauses for fog and smoke incidences using a scale of 1-5: 1=none, 2= less than in standard procedure, 3=same as in standard procedure, 4= more than in standard procedure, 5=much more than in standard procedure. | Day of surgery | 
| A record of complications related to the SurroundScope | The SurroundScope related operative complications, that require further clinical intervention | Day of surgery up to 2 weeks after the surgical procedure |