Assessment of the SurroundScope in Urologic Surgical Procedures

Study Overview
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Brief Summary
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The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope

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 compare the use of the 270Surgical system (The SurroundScope) to standard laparoscope during partial nephrectomy and nephrectomy urological surgeries;

Official Title
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Assessment of the SurroundScope in Urologic Surgical Procedures

Conditions
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Partial Nephrectomy, Nephrectomy, Laparoscopy

Intervention / Treatment
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* Device: SurroundScope
* Device: Standard Laparoscope


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 laparoscopic urologic surgery: Partial nephrectomy, Nephrectomy Exclusion Criteria: Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator) Patients with contraindications to undergo laparoscopic surgery. Patients with American Society of Anesthesiology (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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For laparoscopic camera system to be used in urological surgeries, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used. This will be compared to the standard laparoscopic system use. The study will evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope. The procedure will be performed according to the institution's standard of care, using the SurroundScope or the standard scope for visualization. Each surgery will be captured on video.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SurroundScope<br>For laparoscopic camera system, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used | Device: SurroundScope<br>* The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization.<br>* Other names: 270System;|
| Active Comparator: Standard laparoscope<br>For laparoscopic camera system, the Standard laparoscope that is in a standard use at the medical center is used | Device: Standard Laparoscope<br>* The procedure will be performed according to the institution's standard of care, using the Standard laparoscope for visualization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the efficient work time with the standard scope and the SurroundScope - Time of surgery | Data collected include - skin to skin time of surgery | During the surgery - Since the first incision performed till the last incision is closed | 
| Analysis of the efficient work time with the standard scope and the SurroundScope - tools and ports Visibility time | Data collected include - Visibility time of tools and ports in the Field of view | During the surgery - Since the first incision performed till the last incision is closed | 
| Analysis of the efficient work time with the standard scope and the SurroundScope - time of scope removals | Data collected include - Time of scope removals during the case to clear smoke or fog | During the surgery - Since the first incision performed till the last incision is closed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of defined surgical tasks - port placement time | Time to complete port placement will be measured | During the defined surgical task | 
| Time of defined surgical tasks - transection time | Time to transection of renal artery & Vein with stapler will be measured | During the defined surgical task | 
| Time of defined surgical tasks - clamp time | Clamp time during partial nephrectomy will be measured | During the defined surgical task |