Assessment of the SurroundScope in Urologic Surgical Procedures

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

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopy; Nephrectomy; Partial Nephrectomy
• Intervention / Treatment: Device: SurroundScope; Device: Standard Laparoscope

Detailed Description

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;

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Nado, MD; Phone Number: +972 (0)547228500; Email: nadua@clalit.org.il

Study Locations

• Israel
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
    • Contact: Andrew Nado, MD; Phone Number: +972 (0)547228500; Email: nadua@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Amount of intraoperative adverse event	During the surgery - Since the first incision performed till the last incision is closed
Length of stay	Length of stay at the hospital following the surgery in days	Since the surgery completion to discharge from the medical center
Surgeon's perception 270surgical	Surgeon's perception of the 270surgical System - 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).	Immediately following the surgery is completed

Collaborators and Investigators

• Sponsor: 270Surgical
• Investigators: Principal Investigator: Andrew Nado, MD, Rabin Medical Center, 39 Jabotinski St., Petah Tikva 49100

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CL 466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No