Assessment of the SurroundScope in Urologic Surgical Procedures

Laparoscopy Clinical Trial

Official title:

Assessment of the SurroundScope in Urologic Surgical Procedures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05106218
• Other study ID #: CL 466
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: 270Surgical
• Contact: Andrew Nado, MD
• Phone: +972 (0)547228500
• Email: nadua[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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;

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Laparoscopy
• Nephrectomy
• Partial Nephrectomy

Intervention

Device:
• SurroundScope
The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization.
• Standard Laparoscope
The procedure will be performed according to the institution's standard of care, using the Standard laparoscope for visualization.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
270Surgical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Amount of intraoperative adverse event	During the surgery - Since the first incision performed till the last incision is closed
Other	Length of stay	Length of stay at the hospital following the surgery in days	Since the surgery completion to discharge from the medical center
Other	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
Primary	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
Primary	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
Primary	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	Time of defined surgical tasks - port placement time	Time to complete port placement will be measured	During the defined surgical task
Secondary	Time of defined surgical tasks - transection time	Time to transection of renal artery & Vein with stapler will be measured	During the defined surgical task
Secondary	Time of defined surgical tasks - clamp time	Clamp time during partial nephrectomy will be measured	During the defined surgical task