Assessment of the SurroundScope in Urologic Surgical Procedures

270Surgical

Status: Unknown

Conditions: Laparoscopy; Partial Nephrectomy; Nephrectomy

Treatments: Device: SurroundScope; Device: Standard Laparoscope

Study type: Interventional

Funder types: Industry

Identifiers

NCT05106218

CL 466

Details and patient eligibility

About

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

Full 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;

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

SurroundScope

Experimental group

Description:

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

Treatment:

Device: SurroundScope

Standard laparoscope

Active Comparator group

Description:

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

Treatment:

Device: Standard Laparoscope