Clinical trial NCT05106218: Assessment of the SurroundScope in Urologic Surgical Procedures
Official title: Assessment of the SurroundScope in Urologic Surgical Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Partial Nephrectomy
Nephrectomy
Laparoscopy
Lead sponsor: 270Surgical
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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;

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)

Primary outcomes:
measure: Analysis of the efficient work time with the standard scope and the SurroundScope - Time of surgery
timeFrame: During the surgery - Since the first incision performed till the last incision is closed
measure: Analysis of the efficient work time with the standard scope and the SurroundScope - tools and ports Visibility time
timeFrame: During the surgery - Since the first incision performed till the last incision is closed
measure: Analysis of the efficient work time with the standard scope and the SurroundScope - time of scope removals
timeFrame: During the surgery - Since the first incision performed till the last incision is closed
Secondary outcomes:
measure: Time of defined surgical tasks - port placement time
timeFrame: During the defined surgical task
measure: Time of defined surgical tasks - transection time
timeFrame: During the defined surgical task
measure: Time of defined surgical tasks - clamp time
timeFrame: During the defined surgical task
Other outcomes:
measure: Adverse events
timeFrame: During the surgery - Since the first incision performed till the last incision is closed
measure: Length of stay
timeFrame: Since the surgery completion to discharge from the medical center
measure: Surgeon's perception 270surgical
timeFrame: Immediately following the surgery is completed
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center, 39 Jabotinski St., Petah Tikva 49100
name: Andrew Nado, MD
role: PRINCIPAL_INVESTIGATOR
References: