Assessment of the SurroundScope in Urologic Surgical Procedures

NCT ID: NCT05106218

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2022-12-31

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;

Conditions

Partial Nephrectomy; Nephrectomy; Laparoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SurroundScope

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

Group Type: EXPERIMENTAL

SurroundScope

Intervention Type: DEVICE

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

Standard laparoscope

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

Group Type: ACTIVE_COMPARATOR

Standard Laparoscope

Intervention Type: DEVICE

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

Interventions

SurroundScope

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

Intervention Type: DEVICE

Standard Laparoscope

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

Intervention Type: DEVICE

Other Intervention Names

270System

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

270Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Nado, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Rabin Medical Center

Petah Tikva, , Israel

Countries

Israel

Central Contacts

Andrew Nado, MD

Role: CONTACT

nadua@clalit.org.il

+972 (0)547228500

Facility Contacts

Andrew Nado, MD

Role: primary

nadua@clalit.org.il

+972 (0)547228500

Other Identifiers

CL 466

Identifier Type: -

Identifier Source: org_study_id