Assessment of the SurroundScope in Urologic Surgical Procedures

Not Applicable

• Conditions: Partial Nephrectomy; Nephrectomy; Laparoscopy
• Interventions: Device: SurroundScope; Device: Standard Laparoscope

• Registration Number: NCT05106218
• Lead Sponsor: 270Surgical

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-21
• Status Verified: 2021-11
• Study First Posted: 2021-11-03
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09
• Study Start: 2022-03
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SurroundScope	SurroundScope	For laparoscopic camera system, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used
Standard laparoscope	Standard Laparoscope	For laparoscopic camera system, the Standard laparoscope that is in a standard use at the medical center is used

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time of defined surgical tasks - clamp time	During the defined surgical task	Clamp time during partial nephrectomy will be measured
Time of defined surgical tasks - port placement time	During the defined surgical task	Time to complete port placement will be measured
Time of defined surgical tasks - transection time	During the defined surgical task	Time to transection of renal artery \& Vein with stapler will be measured

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel