Assessment of the SurroundScope in Urologic Surgical Procedures

NCT05106218 | Unknown

• 1 other identifier: CL 466
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Partial Nephrectomy; Nephrectomy; Laparoscopy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Time of defined surgical tasks - port placement time

  During the defined surgical task

• Time of defined surgical tasks - transection time

  During the defined surgical task

• Time of defined surgical tasks - clamp time

  During the defined surgical task

Other Outcomes (3)

• Adverse events

  During the surgery - Since the first incision performed till the last incision is closed

• Length of stay

  Since the surgery completion to discharge from the medical center

• Surgeon's perception 270surgical

  Immediately following the surgery is completed

Study Arms (2)

SurroundScope

EXPERIMENTAL

For laparoscopic camera system, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used

Device: SurroundScope

Standard laparoscope

ACTIVE COMPARATOR

For laparoscopic camera system, the Standard laparoscope that is in a standard use at the medical center is used

Device: Standard Laparoscope

Interventions

SurroundScope DEVICE

The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization.

Also known as: 270System

SurroundScope

Standard Laparoscope DEVICE

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

Standard laparoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18
• Capable of giving informed consent.
• Scheduled for laparoscopic urologic surgery: Partial nephrectomy, Nephrectomy

You may not qualify if:

• 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)

Sponsors & Collaborators

• 270Surgical: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Study Officials

• Andrew Nado, MD

  Rabin Medical Center, 39 Jabotinski St., Petah Tikva 49100

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Nado, MD

CONTACT

+972 (0)547228500; nadua@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are not aware of the laparoscopic system that will be used during the operation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 3, 2021
• Study Start: March 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 9, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)